Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

• ClinicalTrials.gov Identifier: NCT04908475
• Recruitment Status: Completed
• First Posted: June 1, 2021
• Results First Posted: April 30, 2024
• Last Update Posted: April 30, 2024
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psoriasis
• Interventions: Drug: Risankizumab; Drug: Apremilast
• Enrollment: 352

Participant Flow

Recruitment Details

A total of 352 participants were enrolled from 48 sites across 5 countries including Canada, Germany, Israel, Poland, and the United States.

Pre-assignment Details

Period A: participants were randomized in a 1:2 ratio to risankizumab (RZB) or apremilast (APR). Period B: participants receiving RZB were continued up to Week 52; participants receiving APR were re-randomized in a 1:1 ratio to receive either RZB or APR (with the option to receive RZB as rescue) up to Week 52. Rerandomization was stratified by Psoriasis Area and Severity Index (PASI) 75 response (responder, non-responder) at Week 16.

Arm/Group Title	Period A: APR	Periods A/B: RZB/RZB	Period B: APR/APR, NR	Period B: APR/RZB, NR	Period B: APR/APR, R	Period B: APR/RZB, R
Arm/Group Description	Apremilast 30 mg orally twice daily (BID) up to Week 16	Risankizumab 150 mg as a single subcutaneous (SC) injection at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.	Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (responders [R]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.	Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (R) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
Period Title: Period A (Baseline to Week 16)
Started	234	118	0	0	0	0
Completed	216	118	0	0	0	0
Not Completed	18	0	0	0	0	0
Reason Not Completed
Lost to Follow-up	3	0	0	0	0	0
Withdrawal by Subject	9	0	0	0	0	0
Other, Not Specified	6	0	0	0	0	0
Period Title: Period B (Week 16 to Week 52)
Started [1]	0	118	78	83	22	20
Received ≥ 1 Dose of Study Drug	0	116	75	82	22	20
Received RZB as Rescue Medication	0	0	47	0	1	0
Completed	0	69	42	57	15	13
Not Completed	0	49	36	26	7	7
Reason Not Completed
Lost to Follow-up	0	6	4	6	0	0
Withdrawal by Subject	0	5	13	2	3	0
Other, Not Specified	0	38	19	18	4	7
[1] Participants re-randomized in Period B

Baseline Characteristics

Arm/Group Title		Period A: APR	Period A: RZB	Total
Arm/Group Description		Apremilast 30 mg orally BID up to Week 16	Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4.	Total of all reporting groups
Overall Number of Baseline Participants		234	118	352
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	234 participants	118 participants	352 participants
		46.2 (14.27)	45.5 (13.63)	46.0 (14.04)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	234 participants	118 participants	352 participants
	Female	79 33.8%	42 35.6%	121 34.4%
	Male	155 66.2%	76 64.4%	231 65.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	234 participants	118 participants	352 participants
	Hispanic or Latino	23 9.8%	7 5.9%	30 8.5%
	Not Hispanic or Latino	211 90.2%	111 94.1%	322 91.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	234 participants	118 participants	352 participants
	American Indian or Alaska Native	1 0.4%	0 0.0%	1 0.3%
	Asian	14 6.0%	12 10.2%	26 7.4%
	Native Hawaiian or Other Pacific Islander	1 0.4%	2 1.7%	3 0.9%
	Black or African American	9 3.8%	5 4.2%	14 4.0%
	White	209 89.3%	98 83.1%	307 87.2%
	More than one race	0 0.0%	1 0.8%	1 0.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
Description	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT_A Population: all participants randomized in Period A

Arm/Group Title	Period A: APR	Period A: RZB
Arm/Group Description:	Apremilast 30 mg orally BID up to Week 16	Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4
Overall Number of Participants Analyzed	234	118
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	5.1; (2.3 to 8.0)	55.9; (47.0 to 64.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Period A: APR, Period A: RZB
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	Adjusted for strata (baseline body weight [≤ 100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥ 1]) for the comparison of 2 treatment groups.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Difference
	Estimated Value	50.7
	Confidence Interval	(2-Sided) 95%; 41.3 to 60.1
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)
Description	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT_A Population: all participants randomized in Period A.

Arm/Group Title	Period A: APR	Period A: RZB
Arm/Group Description:	Apremilast 30 mg orally BID up to Week 16	Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4.
Overall Number of Participants Analyzed	234	118
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	18.4; (13.4 to 23.3)	75.4; (67.7 to 83.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Period A: APR, Period A: RZB
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	Adjusted for strata (baseline body weight [≤ 100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥ 1]) for the comparison of 2 treatment groups.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Difference
	Estimated Value	56.8
	Confidence Interval	(2-Sided) 95%; 47.7 to 66.0
	Estimation Comments	[Not Specified]

3. Primary Outcome

Title	Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
Description	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.

Arm/Group Title	Period B: APR/APR, NR	Period B: APR/RZB, NR
Arm/Group Description:	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
Overall Number of Participants Analyzed	78	83
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	2.6; (0.0 to 6.1)	72.3; (62.7 to 81.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Period B: APR/APR, NR, Period B: APR/RZB, NR
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	69.7
	Confidence Interval	(2-Sided) 95%; 59.5 to 80.0
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
Description	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITT_A Population: all participants randomized in Period A

Arm/Group Title	Period A: APR	Period A: RZB
Arm/Group Description:	Apremilast 30 mg orally BID up to Week 16	Risankizumab 150 mg as a single SC injection at Baseline (Day 1) and Week 4.
Overall Number of Participants Analyzed	234	118
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	18.8; (13.8 to 23.8)	84.7; (78.3 to 91.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Period A: APR, Period A: RZB
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	Adjusted for strata (baseline body weight [≤ 100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥ 1] for the comparison of 2 treatment groups.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Difference
	Estimated Value	65.9
	Confidence Interval	(2-Sided) 95%; 57.6 to 73.9
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
Description	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.

Arm/Group Title	Period B: APR/APR, NR	Period B: APR/RZB, NR
Arm/Group Description:	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
Overall Number of Participants Analyzed	78	83
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	11.5; (4.4 to 18.6)	83.1; (75.1 to 91.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Period B: APR/APR, NR, Period B: APR/RZB, NR
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	71.6
	Confidence Interval	(2-Sided) 95%; 60.9 to 82.3
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
Description	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.

Arm/Group Title	Period B: APR/APR, NR	Period B: APR/RZB, NR
Arm/Group Description:	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.	Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
Overall Number of Participants Analyzed	78	83
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	7.7; (1.8 to 13.6)	77.1; (68.1 to 86.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Period B: APR/APR, NR, Period B: APR/RZB, NR
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	69.4
	Confidence Interval	(2-Sided) 95%; 58.6 to 80.2
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame

All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).

Adverse Event Reporting Description

Safety Population: participants who received ≥ 1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.

Arm/Group Title

Period A: APR

Period A: RZB

Period B: RZB/RZB

Period B: APR/APR

Period B: APR/RZB

Period B: APR/APR/RZB

Arm/Group Description

Apremilast 30 mg orally BID up to Week 16

Risankizumab 150 mg as a single SC injection at Day 1 and Week 4

Participants who received risankizumab 150 mg as a single subcutaneous (SC) injection at Day 1 and continued on risankizumab at Weeks 16, 28, and 40

Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID up to Week 52.

Participants who received apremilast in Period A who were re-randomized to receive risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, 44.

Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID and received rescue medication with risankizumab.

All-Cause Mortality

Period A: APR

Period A: RZB

Period B: RZB/RZB

Period B: APR/APR

Period B: APR/RZB

Period B: APR/APR/RZB

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/234 (0.00%)

0/118 (0.00%)

0/116 (0.00%)

0/97 (0.00%)

0/102 (0.00%)

0/48 (0.00%)

Serious Adverse Events

Period A: APR

Period A: RZB

Period B: RZB/RZB

Period B: APR/APR

Period B: APR/RZB

Period B: APR/APR/RZB

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

4/234 (1.71%)

1/118 (0.85%)

8/116 (6.90%)

2/97 (2.06%)

3/102 (2.94%)

0/48 (0.00%)

Cardiac disorders

ACUTE MYOCARDIAL INFARCTION † 1

1/234 (0.43%)

1

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

CORONARY ARTERY DISEASE † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

0/116 (0.00%)

0

1/97 (1.03%)

1

0/102 (0.00%)

0

0/48 (0.00%)

0

Gastrointestinal disorders

GASTROINTESTINAL HAEMORRHAGE † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

1/102 (0.98%)

1

0/48 (0.00%)

0

OBSTRUCTIVE PANCREATITIS † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

SMALL INTESTINAL OBSTRUCTION † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

UMBILICAL HERNIA † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

Immune system disorders

HYPERSENSITIVITY † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

1/102 (0.98%)

1

0/48 (0.00%)

0

Infections and infestations

APPENDICITIS PERFORATED † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

SEPSIS † 1

1/234 (0.43%)

1

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

Injury, poisoning and procedural complications

FALL † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

1/102 (0.98%)

1

0/48 (0.00%)

0

LOWER LIMB FRACTURE † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

1/102 (0.98%)

1

0/48 (0.00%)

0

Metabolism and nutrition disorders

HYPONATRAEMIA † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

Musculoskeletal and connective tissue disorders

OSTEOARTHRITIS † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

OSTEOCHONDROSIS † 1

1/234 (0.43%)

1

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

PROSTATE CANCER † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

0/116 (0.00%)

0

1/97 (1.03%)

1

0/102 (0.00%)

0

0/48 (0.00%)

0

Nervous system disorders

CAROTID ARTERY STENOSIS † 1

1/234 (0.43%)

1

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

GENERALISED TONIC-CLONIC SEIZURE † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

SCIATICA † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

1/116 (0.86%)

1

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

Respiratory, thoracic and mediastinal disorders

NASAL INFLAMMATION † 1

0/234 (0.00%)

0

1/118 (0.85%)

1

0/116 (0.00%)

0

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

PULMONARY EMBOLISM † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

2/116 (1.72%)

2

0/97 (0.00%)

0

0/102 (0.00%)

0

0/48 (0.00%)

0

Skin and subcutaneous tissue disorders

URTICARIA † 1

0/234 (0.00%)

0

0/118 (0.00%)

0

0/116 (0.00%)

0

0/97 (0.00%)

0

1/102 (0.98%)

2

0/48 (0.00%)

0

1 Term from vocabulary, MedDRA 25.1; † Indicates events were collected by systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

5%

Period A: APR

Period A: RZB

Period B: RZB/RZB

Period B: APR/APR

Period B: APR/RZB

Period B: APR/APR/RZB

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

101/234 (43.16%)

24/118 (20.34%)

36/116 (31.03%)

27/97 (27.84%)

31/102 (30.39%)

15/48 (31.25%)

Gastrointestinal disorders

DIARRHOEA † 1

47/234 (20.09%)

50

1/118 (0.85%)

1

0/116 (0.00%)

0

1/97 (1.03%)

1

1/102 (0.98%)

1

0/48 (0.00%)

0

NAUSEA † 1

41/234 (17.52%)

45

0/118 (0.00%)

0

2/116 (1.72%)

2

3/97 (3.09%)

3

0/102 (0.00%)

0

0/48 (0.00%)

0

Infections and infestations

COVID-19 † 1

16/234 (6.84%)

16

13/118 (11.02%)

13

19/116 (16.38%)

20

14/97 (14.43%)

14

12/102 (11.76%)

12

6/48 (12.50%)

6

NASOPHARYNGITIS † 1

10/234 (4.27%)

13

4/118 (3.39%)

5

11/116 (9.48%)

14

8/97 (8.25%)

10

10/102 (9.80%)

11

5/48 (10.42%)

6

UPPER RESPIRATORY TRACT INFECTION † 1

2/234 (0.85%)

2

3/118 (2.54%)

3

5/116 (4.31%)

5

3/97 (3.09%)

3

6/102 (5.88%)

8

1/48 (2.08%)

1

Nervous system disorders

HEADACHE † 1

27/234 (11.54%)

28

3/118 (2.54%)

3

1/116 (0.86%)

1

4/97 (4.12%)

4

5/102 (4.90%)

6

1/48 (2.08%)

1

Vascular disorders

HYPERTENSION † 1

3/234 (1.28%)

3

2/118 (1.69%)

2

6/116 (5.17%)

6

0/97 (0.00%)

0

1/102 (0.98%)

1

3/48 (6.25%)

3

1 Term from vocabulary, MedDRA 25.1; † 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.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

• Name/Title: Global Medical Services
• Organization: AbbVie
• Phone: 800-633-9110
• EMail: abbvieclinicaltrials@abbvie.com

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT04908475
• Other Study ID Numbers: M20-326; 2020-005512-21 ( EudraCT Number )
• First Submitted: May 28, 2021
• First Posted: June 1, 2021
• Results First Submitted: April 2, 2024
• Results First Posted: April 30, 2024
• Last Update Posted: April 30, 2024