An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis (POETYK-PSO-2)

• ClinicalTrials.gov Identifier: NCT03611751
• Recruitment Status: Completed
• First Posted: August 2, 2018
• Results First Posted: December 20, 2022
• Last Update Posted: December 20, 2022
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psoriasis
• Interventions: Drug: BMS-986165; Other: Placebo; Drug: Apremilast
• Enrollment: 1020

Participant Flow

Recruitment Details
Pre-assignment Details	1 Participant stopped treatment after week 16 and re-entered in treatment period Week 24-52.

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Period Title: Pre-treatment
Started	511	255	254
Completed	510	254	254
Not Completed	1	1	0
Reason Not Completed
Randomized but not treated	1	1	0
Period Title: Treatment Week 0 - Week 16
Started	510	254	254
Completed	456	212	217
Not Completed	54	42	37
Reason Not Completed
Adverse Event	11	7	12
Lack of Efficacy	6	9	4
Lost to Follow-up	5	6	2
Non-compliance with protocol	5	2	1
Withdrawal by Subject	14	9	9
Other reasons	13	9	7
Pregnancy	0	0	1
Death	0	0	1
Period Title: Treatment Week 16 - Week 24
Started	667	0	217
Completed	642	0	208
Not Completed	25	0	9
Reason Not Completed
Adverse Event	7	0	2
Lack of Efficacy	8	0	1
Lost to Follow-up	2	0	0
Non-compliance with protocol	3	0	1
Withdrawal by Subject	2	0	1
Other reasons	2	0	3
Pregnancy	1	0	1
Period Title: Treatment Week 24 - Week 52
Started	604	247	0
Completed	535	214	0
Not Completed	69	33	0
Reason Not Completed
Adverse Event	14	7	0
Lack of Efficacy	8	8	0
Lost to Follow-up	9	4	0
Non-compliance with protocol	2	0	0
Withdrawal by Subject	8	6	0
Other reasons	28	7	0
Pregnancy	0	1	0

Baseline Characteristics

Arm/Group Title		BMS-986165	Placebo	Apremilast	Total
Arm/Group Description		Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.	Total of all reporting groups
Overall Number of Baseline Participants		511	255	254	1020
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	511 participants	255 participants	254 participants	1020 participants
		46.9 (13.37)	47.3 (13.57)	46.4 (13.28)	46.9 (13.39)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	511 participants	255 participants	254 participants	1020 participants
	Female	175 34.2%	74 29.0%	97 38.2%	346 33.9%
	Male	336 65.8%	181 71.0%	157 61.8%	674 66.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	511 participants	255 participants	254 participants	1020 participants
	Hispanic or Latino	58 11.4%	29 11.4%	29 11.4%	116 11.4%
	Not Hispanic or Latino	445 87.1%	226 88.6%	223 87.8%	894 87.6%
	Unknown or Not Reported	8 1.6%	0 0.0%	2 0.8%	10 1.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	511 participants	255 participants	254 participants	1020 participants
	White	474 92.8%	232 91.0%	229 90.2%	935 91.7%
	Black or African American	8 1.6%	9 3.5%	9 3.5%	26 2.5%
	Asian	24 4.7%	8 3.1%	12 4.7%	44 4.3%
	American Indian or Alaska Native	2 0.4%	2 0.8%	3 1.2%	7 0.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Other	3 0.6%	4 1.6%	1 0.4%	8 0.8%

Outcome Measures

1. Primary Outcome

Title	The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
Description	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants in the BMS-986165 and Placebo arms

Arm/Group Title	BMS-986165	Placebo
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Overall Number of Participants Analyzed	511	255
Measure Type: Count of Participants; Unit of Measure: Participants
	253 49.5%	22 8.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	10.55
	Confidence Interval	(2-Sided) 95%; 6.54 to 17.00
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
Description	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants in the BMS-986165 and Placebo arms

Arm/Group Title	BMS-986165	Placebo
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Overall Number of Participants Analyzed	511	255
Measure Type: Count of Participants; Unit of Measure: Participants
	271 53.0%	24 9.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	10.49
	Confidence Interval	(2-Sided) 95%; 6.65 to 16.55
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
Description	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	511	255	254
Measure Type: Count of Participants; Unit of Measure: Participants
	138 27.0%	7 2.7%	46 18.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	11.42
	Confidence Interval	(2-Sided) 95%; 5.45 to 23.93
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0046
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.74
	Confidence Interval	(2-Sided) 95%; 1.18 to 2.56
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
Description	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	511	255	254
Measure Type: Count of Participants; Unit of Measure: Participants
	52 10.2%	3 1.2%	11 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9.21
	Confidence Interval	(2-Sided) 95%; 2.89 to 29.40
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0051
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.55
	Confidence Interval	(2-Sided) 95%; 1.30 to 5.00
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
Description	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	511	255	254
Measure Type: Count of Participants; Unit of Measure: Participants
	80	3	16

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	14.44
	Confidence Interval	(2-Sided) 95%; 4.62 to 45.11
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.85
	Confidence Interval	(2-Sided) 95%; 1.61 to 5.03
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
Description	PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0). A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants with evaluable baseline and week 16 PSSD scores.

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	466	239	233
Mean (Standard Deviation); Unit of Measure: Score on a scale
	-28.9 (25.22)	-4.2 (19.58)	-21.5 (25.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-23.6
	Confidence Interval	(2-Sided) 95%; -26.9 to -20.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.67
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.2
	Confidence Interval	(2-Sided) 95%; -10.5 to -3.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.68
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
Description	Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline PSSD symptom score ≥ 1

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	466	238	232
Measure Type: Count of Participants; Unit of Measure: Participants
	35 7.5%	3 1.3%	10 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.40
	Confidence Interval	(2-Sided) 95%; 1.94 to 21.15
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0928
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.82
	Confidence Interval	(2-Sided) 95%; 0.89 to 3.71
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)
Description	The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 . Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline ss-PGA score >=3

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	305	173	166
Measure Type: Count of Participants; Unit of Measure: Participants
	182 59.7%	30 17.3%	61 36.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.85
	Confidence Interval	(2-Sided) 95%; 4.34 to 10.81
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.63
	Confidence Interval	(2-Sided) 95%; 1.77 to 3.91
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)
Description	The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline DLQI score >=2. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.

Arm/Group Title	BMS-986165	Placebo
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Overall Number of Participants Analyzed	495	246
Measure Type: Count of Participants; Unit of Measure: Participants
	186	24

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.38
	Confidence Interval	(2-Sided) 95%; 3.42 to 8.47
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)
Description	The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline PGA-F score >=3. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.

Arm/Group Title	BMS-986165	Placebo
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Overall Number of Participants Analyzed	69	38
Measure Type: Count of Participants; Unit of Measure: Participants
	14	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0621
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.21
	Confidence Interval	(2-Sided) 95%; 0.88 to 11.79
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)
Description	The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline pp-PGA score >=3.

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	39	17	20
Measure Type: Count of Participants; Unit of Measure: Participants
	18	4	8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6692
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.06 to 7.46
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3793
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95%; 0.02 to 5.56
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
Description	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants in the BMS-986165 and Apremilast arms.

Arm/Group Title	BMS-986165	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	511	254
Measure Type: Count of Participants; Unit of Measure: Participants
	271 53.0%	101 39.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.76
	Confidence Interval	(2-Sided) 95%; 1.29 to 2.41
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
Description	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants in the BMS-986165 and Apremilast arms.

Arm/Group Title	BMS-986165	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	511	254
Measure Type: Count of Participants; Unit of Measure: Participants
	253 49.5%	86 33.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.01
	Confidence Interval	(2-Sided) 95%; 1.45 to 2.78
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
Description	Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline. The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.
Time Frame	From Week 24 to Week 52 (up to approximately 28 weeks)

Outcome Measure Data

Analysis Population Description

All randomized participants who had PASI 75 response at week 24. Pre-specified to report participants from their original randomization.

Arm/Group Title	BMS-986165	Placebo	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	145	150	95
Median (95% Confidence Interval); Unit of Measure: Days
	NA [1]; (NA to NA)	NA [1]; (NA to NA)	197.0 [1]; (125.0 to NA)

[1]

Insufficient number of participants with events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

15. Secondary Outcome

Title	The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)
Description	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.

Arm/Group Title	BMS-986165	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	504	254
Measure Type: Count of Participants; Unit of Measure: Participants
	251	75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.47
	Confidence Interval	(2-Sided) 95%; 1.78 to 3.43
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)
Description	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.

Arm/Group Title	BMS-986165	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	504	254
Measure Type: Count of Participants; Unit of Measure: Participants
	296	96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.44
	Confidence Interval	(2-Sided) 95%; 1.78 to 3.36
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
Description	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.

Arm/Group Title	BMS-986165	Apremilast
Arm/Group Description:	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label); 10 mg used for titration Day 1 through Day 3 morning dose; 20 mg used for titration Day 3 evening dose through Day 5 morning dose.; 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Overall Number of Participants Analyzed	504	254
Measure Type: Count of Participants; Unit of Measure: Participants
	164	50

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BMS-986165, Apremilast
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.07
	Confidence Interval	(2-Sided) 95%; 1.43 to 3.01
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks)
Adverse Event Reporting Description	The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Arm/Group Title	BMS-986165 (Week 0 up to Week 16)	Placebo (Week 0 up to Week 16)	Apremilast (Week 0 up to Week 16)	BMS-986165 (Week 0 up to Week 52)	Placebo (Week 0 up to Week 52)	Apremilast (Week 0 up to Week 52)
Arm/Group Description	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)	Participants receive Placebo by oral administration once daily (QD)	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) 10 mg used for titration Day 1 through Day 3 morning dose 20 mg used for titration Day 3 evening dose through Day 5 morning dose. 30 mg from Day 5 evening dose onwards	Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)	Participants receive Placebo by oral administration once daily (QD)	Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) 10 mg used for titration Day 1 through Day 3 morning dose 20 mg used for titration Day 3 evening dose through Day 5 morning dose. 30 mg from Day 5 evening dose onwards
All-Cause Mortality
	BMS-986165 (Week 0 up to Week 16)	Placebo (Week 0 up to Week 16)	Apremilast (Week 0 up to Week 16)	BMS-986165 (Week 0 up to Week 52)	Placebo (Week 0 up to Week 52)	Apremilast (Week 0 up to Week 52)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/511 (0.20%)	0/255 (0.00%)	1/254 (0.39%)	2/834 (0.24%)	0/502 (0.00%)	1/254 (0.39%)
Serious Adverse Events
	BMS-986165 (Week 0 up to Week 16)	Placebo (Week 0 up to Week 16)	Apremilast (Week 0 up to Week 16)	BMS-986165 (Week 0 up to Week 52)	Placebo (Week 0 up to Week 52)	Apremilast (Week 0 up to Week 52)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/510 (1.57%)	3/254 (1.18%)	1/254 (0.39%)	24/833 (2.88%)	5/501 (1.00%)	3/254 (1.18%)
Cardiac disorders
Arteriosclerosis coronary artery † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Atrial fibrillation † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Cardiac arrest † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Cardiac failure † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Myocardial ischaemia † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Pericardial effusion † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	0/833 (0.00%)	1/501 (0.20%)	0/254 (0.00%)
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation † 1	0/510 (0.00%)	0/254 (0.00%)	1/254 (0.39%)	0/833 (0.00%)	0/501 (0.00%)	1/254 (0.39%)
Eye disorders
Retinal detachment † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Gastrointestinal disorders
Anal polyp † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	0/833 (0.00%)	1/501 (0.20%)	0/254 (0.00%)
Gastrointestinal haemorrhage † 1	1/510 (0.20%)	0/254 (0.00%)	1/254 (0.39%)	1/833 (0.12%)	0/501 (0.00%)	1/254 (0.39%)
Pancreatic mass † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Hepatobiliary disorders
Hepatitis † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Immune system disorders
Anaphylactic reaction † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Infections and infestations
Anal abscess † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
COVID-19 † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Cellulitis † 1	0/510 (0.00%)	1/254 (0.39%)	0/254 (0.00%)	0/833 (0.00%)	1/501 (0.20%)	0/254 (0.00%)
Diverticulitis † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Mycoplasma infection † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	0/833 (0.00%)	0/501 (0.00%)	1/254 (0.39%)
Pneumonia † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	3/833 (0.36%)	0/501 (0.00%)	0/254 (0.00%)
Purulence † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Sepsis † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Streptococcal bacteraemia † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Upper respiratory tract infection † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Vascular graft infection † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Injury, poisoning and procedural complications
Post procedural haemorrhage † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Metabolism and nutrition disorders
Dehydration † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Diabetes mellitus † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Lung adenocarcinoma † 1	0/510 (0.00%)	0/254 (0.00%)	1/254 (0.39%)	0/833 (0.00%)	0/501 (0.00%)	1/254 (0.39%)
Nervous system disorders
Cerebrovascular accident † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Ischaemic stroke † 1	0/510 (0.00%)	0/254 (0.00%)	1/254 (0.39%)	0/833 (0.00%)	0/501 (0.00%)	1/254 (0.39%)
Psychiatric disorders
Major depression † 1	0/510 (0.00%)	1/254 (0.39%)	0/254 (0.00%)	0/833 (0.00%)	1/501 (0.20%)	0/254 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Reproductive system and breast disorders
Ovarian cyst † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	0/833 (0.00%)	0/501 (0.00%)	1/254 (0.39%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	0/833 (0.00%)	1/501 (0.20%)	0/254 (0.00%)
Chronic obstructive pulmonary disease † 1	0/510 (0.00%)	1/254 (0.39%)	0/254 (0.00%)	0/833 (0.00%)	1/501 (0.20%)	0/254 (0.00%)
Nasal septum deviation † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Respiratory failure † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Skin and subcutaneous tissue disorders
Excessive granulation tissue † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Vascular disorders
Malignant hypertension † 1	1/510 (0.20%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Peripheral artery occlusion † 1	0/510 (0.00%)	1/254 (0.39%)	0/254 (0.00%)	0/833 (0.00%)	1/501 (0.20%)	0/254 (0.00%)
Shock † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
Thrombosis † 1	0/510 (0.00%)	0/254 (0.00%)	0/254 (0.00%)	1/833 (0.12%)	0/501 (0.00%)	0/254 (0.00%)
1 Term from vocabulary, MedDRA 23.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	BMS-986165 (Week 0 up to Week 16)	Placebo (Week 0 up to Week 16)	Apremilast (Week 0 up to Week 16)	BMS-986165 (Week 0 up to Week 52)	Placebo (Week 0 up to Week 52)	Apremilast (Week 0 up to Week 52)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	114/510 (22.35%)	61/254 (24.02%)	86/254 (33.86%)	249/833 (29.89%)	97/501 (19.36%)	98/254 (38.58%)
Gastrointestinal disorders
Diarrhoea † 1	24/510 (4.71%)	19/254 (7.48%)	33/254 (12.99%)	39/833 (4.68%)	22/501 (4.39%)	35/254 (13.78%)
Nausea † 1	7/510 (1.37%)	3/254 (1.18%)	23/254 (9.06%)	13/833 (1.56%)	6/501 (1.20%)	26/254 (10.24%)
Infections and infestations
Nasopharyngitis † 1	55/510 (10.78%)	29/254 (11.42%)	23/254 (9.06%)	133/833 (15.97%)	47/501 (9.38%)	28/254 (11.02%)
Upper respiratory tract infection † 1	25/510 (4.90%)	11/254 (4.33%)	14/254 (5.51%)	74/833 (8.88%)	27/501 (5.39%)	21/254 (8.27%)
Nervous system disorders
Headache † 1	22/510 (4.31%)	14/254 (5.51%)	28/254 (11.02%)	45/833 (5.40%)	16/501 (3.19%)	30/254 (11.81%)
1 Term from vocabulary, MedDRA 23.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Results Point of Contact

• Name/Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb
• Phone: Please email
• EMail: Clinical.Trials@bms.com

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03611751
• Other Study ID Numbers: IM011-047; 2018-001925-24 ( EudraCT Number )
• First Submitted: July 25, 2018
• First Posted: August 2, 2018
• Results First Submitted: October 6, 2022
• Results First Posted: December 20, 2022
• Last Update Posted: December 20, 2022