Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

• ClinicalTrials.gov Identifier: NCT04605978
• Recruitment Status: Completed
• First Posted: October 28, 2020
• Results First Posted: April 23, 2024
• Last Update Posted: April 23, 2024
• Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company
• Information provided by (Responsible Party): Servier ( Institut de Recherches Internationales Servier )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Primary Sjögren's Syndrome
• Interventions: Drug: S95011 concentrate for solution for infusion; Drug: Placebo concentrate for solution for infusion
• Enrollment: 48

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description	S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Period Title: Overall Study
Started	31	17
Completed	28	15
Not Completed	3	2
Reason Not Completed
Adverse Event	2	1
Withdrawal nonmedical reason	1	1

Baseline Characteristics

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion	Total
Arm/Group Description		S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	Total of all reporting groups
Overall Number of Baseline Participants		31	17	48
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	31 participants	17 participants	48 participants
		53.7 (12.6)	53.6 (12.5)	53.7 (12.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	31 participants	17 participants	48 participants
	Female	26 83.9%	16 94.1%	42 87.5%
	Male	5 16.1%	1 5.9%	6 12.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	31 participants	17 participants	48 participants
	White	28 90.3%	16 94.1%	44 91.7%
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	2 6.5%	0 0.0%	2 4.2%
	Black or African American	1 3.2%	0 0.0%	1 2.1%
	Native Hawaiian or other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Other	0 0.0%	1 5.9%	1 2.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Ethnicity	Number Analyzed	31 participants	17 participants	48 participants
	Hispanic or Latino	1 3.2%	1 5.9%	2 4.2%
	Not Hispanic or Latino	30 96.8%	16 94.1%	46 95.8%
Duration since diagnosis of pSS (years); Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	31 participants	17 participants	48 participants
		7.6 (7.7)	6.5 (6.6)	7.2 (7.3)
Patient taking a specific treatment for pSS (for randomization stratification); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	31 participants	17 participants	48 participants
	Nothing	17 54.8%	8 47.1%	25 52.1%
	Oral corticosteroid	4 12.9%	1 5.9%	5 10.4%
	Antimalarial	5 16.1%	5 29.4%	10 20.8%
	Oral corticosteroid and antimalarial	5 16.1%	3 17.6%	8 16.7%

Outcome Measures

1. Primary Outcome

Title	Change in ESSDAI Total Score
Description	Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
Time Frame	From baseline to week 13

Outcome Measure Data

Analysis Population Description

Change in ESSDAI Total Score is computed only on observed values before occurrence of Intercurrent Events.

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:		S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Overall Number of Participants Analyzed		31	17
Mean (Standard Deviation); Unit of Measure: score on a scale
Change from Baseline to Week 13	Number Analyzed	26 participants	13 participants
		-3.77 (4.55)	-5.54 (4.89)
Baseline	Number Analyzed	31 participants	17 participants
		11.52 (3.75)	13.12 (7.20)
Week 13	Number Analyzed	26 participants	13 participants
		7.96 (4.91)	8.85 (8.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	S95011 Concentrate for Solution for Infusion
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.44
	Confidence Interval	(2-Sided) 95%; -0.61 to 5.49
	Estimation Comments	Missing data and data post intercurrent event were imputed for the statistical analysis as specified in the statistical analysis plan.

2. Secondary Outcome

Title	ESSDAI Score by Domain and Total Score
Description	Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. There are 12 organ-specific domains and for each domain, features of disease activity are scored according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The total score ranges from 0 to 123. A higher score always represents a more severe disease activity. The domain [weight] and score range are as follows: Constitutional [3] 0-2; Lymphadenopathy and lymphoma [4] 0-3; Glandular [2] 0-2; Articular [2] 0-3; Cutaneous [3] 0-3; Pulmonary [5] 0-3; Renal [5] 0-3; Muscular [6] 0-3; PNS [5] 0-3; CNS [5] 0-3; Hematological [2] 0-3; Biological [1] 0-2.
Time Frame	At baseline, week 4 and week 13

Outcome Measure Data

Analysis Population Description

ESSDAI Score by Domain and Total Score is computed without consideration of Intercurrent Events, therefore data gathered after an intercurrent event is not set as "missing". The participant data that is missing from Week 4 and Week 13 was not available.

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:		S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Overall Number of Participants Analyzed		31	17
Mean (Standard Deviation); Unit of Measure: score on a scale
Total Score - Baseline	Number Analyzed	31 participants	17 participants
		11.5 (3.7)	13.1 (7.2)
Total Score - Week 4	Number Analyzed	31 participants	16 participants
		9.5 (3.7)	10.8 (7.2)
Total Score - Week 13	Number Analyzed	28 participants	15 participants
		7.8 (4.8)	9.7 (8.3)
Constitutional - Baseline	Number Analyzed	31 participants	17 participants
		0.6 (0.7)	0.4 (0.6)
Constitutional - Week 4	Number Analyzed	31 participants	16 participants
		0.5 (0.7)	0.2 (0.4)
Constitutional - Week 13	Number Analyzed	28 participants	15 participants
		0.4 (0.7)	0.2 (0.6)
Lymphadenopathy and lymphoma - Baseline	Number Analyzed	31 participants	17 participants
		0.5 (0.8)	0.6 (0.6)
Lymphadenopathy and lymphoma - Week 4	Number Analyzed	31 participants	16 participants
		0.3 (0.7)	0.3 (0.5)
Lymphadenopathy and lymphoma - Week 13	Number Analyzed	28 participants	15 participants
		0.4 (0.7)	0.4 (0.5)
Glandular - Baseline	Number Analyzed	31 participants	17 participants
		0.7 (0.7)	0.7 (0.7)
Glandular - Week 4	Number Analyzed	31 participants	16 participants
		0.6 (0.6)	0.6 (0.6)
Glandular - Week 13	Number Analyzed	28 participants	15 participants
		0.4 (0.6)	0.5 (0.7)
Articular - Baseline	Number Analyzed	31 participants	17 participants
		1.5 (1.1)	1.6 (1.2)
Articular - Week 4	Number Analyzed	31 participants	16 participants
		1.1 (1.1)	1.3 (1.3)
Articular - Week 13	Number Analyzed	28 participants	15 participants
		0.6 (0.7)	0.7 (1.0)
Cutaneous - Baseline	Number Analyzed	31 participants	17 participants
		0.3 (0.6)	0.1 (0.5)
Cutaneous - Week 4	Number Analyzed	31 participants	16 participants
		0.2 (0.6)	0.1 (0.5)
Cutaneous - Week 13	Number Analyzed	28 participants	15 participants
		0.3 (0.6)	0.2 (0.8)
Pulmonary - Baseline	Number Analyzed	31 participants	17 participants
		0.0 (0.2)	0.3 (0.6)
Pulmonary - Week 4	Number Analyzed	31 participants	16 participants
		0.0 (0.2)	0.3 (0.6)
Pulmonary - Week 13	Number Analyzed	28 participants	15 participants
		0.0 (0.0)	0.2 (0.6)
Renal - Baseline	Number Analyzed	31 participants	17 participants
		0.0 (0.0)	0.0 (0.0)
Renal - Week 4	Number Analyzed	31 participants	16 participants
		0.0 (0.0)	0.0 (0.0)
Renal - Week 13	Number Analyzed	28 participants	15 participants
		0.0 (0.0)	0.0 (0.0)
Muscular - Baseline	Number Analyzed	31 participants	17 participants
		0.0 (0.0)	0.0 (0.0)
Muscular - Week 4	Number Analyzed	31 participants	16 participants
		0.0 (0.0)	0.0 (0.0)
Muscular - Week 13	Number Analyzed	28 participants	15 participants
		0.0 (0.0)	0.0 (0.0)
Peripheral Nervous System (PNS) - Baseline	Number Analyzed	31 participants	17 participants
		0.1 (0.2)	0.2 (0.5)
Peripheral Nervous System (PNS) - Week 4	Number Analyzed	31 participants	16 participants
		0.0 (0.2)	0.2 (0.5)
Peripheral Nervous System (PNS) - Week 13	Number Analyzed	28 participants	15 participants
		0.0 (0.2)	0.2 (0.6)
Central Nervous System (CNS) - Baseline	Number Analyzed	31 participants	17 participants
		0.0 (0.0)	0.1 (0.5)
Central Nervous System (CNS) - Week 4	Number Analyzed	31 participants	16 participants
		0.0 (0.0)	0.1 (0.5)
Central Nervous System (CNS) - Week 13	Number Analyzed	28 participants	15 participants
		0.0 (0.0)	0.1 (0.5)
Hematological - Baseline	Number Analyzed	31 participants	17 participants
		0.6 (0.7)	0.4 (0.5)
Hematological - Week 4	Number Analyzed	31 participants	16 participants
		0.7 (0.7)	0.5 (0.5)
Hematological - Week 13	Number Analyzed	28 participants	15 participants
		0.8 (0.8)	0.4 (0.5)
Biological - Baseline	Number Analyzed	31 participants	17 participants
		0.9 (0.8)	0.8 (0.8)
Biological - Week 4	Number Analyzed	31 participants	16 participants
		0.9 (0.8)	0.9 (0.9)
Biological - Week 13	Number Analyzed	28 participants	15 participants
		0.8 (0.8)	1.1 (0.9)

3. Secondary Outcome

Title	ESSPRI Score by Symptom and Total Score
Description	Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome. The three domains included in this scale are dryness, fatigue, and pain, each of which are scored on a scale of 0-10. The total score is calculated as the average of the three domain scores and therefore the maximum total score is 10. The higher score represents more severe symptoms.
Time Frame	At baseline, week 4 and week 13

Outcome Measure Data

Analysis Population Description

The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:		S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Overall Number of Participants Analyzed		31	17
Mean (Standard Deviation); Unit of Measure: score on a scale
Total score - Baseline	Number Analyzed	28 participants	17 participants
		7.14 (1.59)	6.87 (1.65)
Total score - Week 4	Number Analyzed	24 participants	14 participants
		6.65 (1.83)	5.19 (1.97)
Total score - Week 13	Number Analyzed	24 participants	13 participants
		5.54 (2.06)	5.40 (2.71)
Dryness score - Baseline	Number Analyzed	28 participants	17 participants
		7.46 (1.69)	7.06 (2.38)
Dryness score - Week 4	Number Analyzed	24 participants	14 participants
		6.96 (2.20)	5.64 (2.47)
Dryness score - Week 13	Number Analyzed	24 participants	13 participants
		6.54 (1.91)	6.62 (2.43)
Fatigue score - Baseline	Number Analyzed	28 participants	17 participants
		7.43 (1.43)	7.18 (2.24)
Fatigue score - Week 4	Number Analyzed	24 participants	14 participants
		6.88 (2.15)	5.29 (2.58)
Fatigue score - Week 13	Number Analyzed	24 participants	13 participants
		5.71 (2.74)	5.15 (3.21)
Pain score - Baseline	Number Analyzed	28 participants	17 participants
		6.54 (2.63)	6.35 (2.21)
Pain score - Week 4	Number Analyzed	24 participants	14 participants
		6.13 (2.85)	4.64 (2.71)
Pain score - Week 13	Number Analyzed	24 participants	13 participants
		4.38 (3.21)	4.46 (3.57)

4. Secondary Outcome

Title	Quality of Life (SF-36)
Description	Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL. Scores for each subscale range from 0 - 100, with a lower number representing a worse quality of life.
Time Frame	At baseline and week 13

Outcome Measure Data

Analysis Population Description

The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:		S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Overall Number of Participants Analyzed		31	17
Mean (Standard Deviation); Unit of Measure: score on a scale
Physical score - Baseline	Number Analyzed	28 participants	17 participants
		38.729 (9.742)	40.295 (8.236)
Physical score - Week 13	Number Analyzed	23 participants	13 participants
		45.139 (9.409)	47.011 (9.819)
Mental score - Baseline	Number Analyzed	28 participants	17 participants
		40.911 (10.909)	44.182 (13.208)
Mental score - Week 13	Number Analyzed	23 participants	13 participants
		41.970 (14.562)	45.050 (14.275)

5. Secondary Outcome

Title	Fatigue (MFI)
Description	Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate five dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue.
Time Frame	At baseline and week 13

Outcome Measure Data

Analysis Population Description

The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline (for all domains) but observed data at other timepoints and inversely).

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:		S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Overall Number of Participants Analyzed		31	17
Mean (Standard Deviation); Unit of Measure: score on a scale
General fatigue score - Baseline	Number Analyzed	28 participants	17 participants
		15.1 (3.0)	15.2 (3.6)
General fatigue score - Week 13	Number Analyzed	23 participants	13 participants
		13.2 (3.5)	13.5 (5.3)
Physical fatigue score - Baseline	Number Analyzed	28 participants	17 participants
		14.3 (2.7)	13.9 (3.9)
Physical fatigue score - Week 13	Number Analyzed	23 participants	13 participants
		12.6 (3.9)	11.4 (5.2)
Reduced activity score - Baseline	Number Analyzed	28 participants	17 participants
		12.9 (3.0)	12.3 (3.8)
Reduced activity score - Week 13	Number Analyzed	23 participants	13 participants
		11.4 (4.7)	9.7 (4.3)
Reduced motivation score - Baseline	Number Analyzed	27 participants	16 participants
		11.3 (4.1)	9.1 (3.1)
Reduced motivation score - Week 13	Number Analyzed	23 participants	13 participants
		10.3 (4.5)	8.8 (4.5)
Mental fatigue score - Baseline	Number Analyzed	28 participants	17 participants
		11.6 (3.9)	10.5 (3.7)
Mental fatigue score - Week 13	Number Analyzed	23 participants	13 participants
		11.4 (4.9)	9.5 (4.1)

6. Secondary Outcome

Title	Physician's Global Assessment (PhGA) of the Disease Activity
Description	Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
Time Frame	At baseline and week 13

Outcome Measure Data

Analysis Population Description

The number analyzed for Week 13 is less due to missing patient data.

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:		S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Overall Number of Participants Analyzed		31	17
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	31 participants	17 participants
		6.0 (1.5)	6.3 (1.3)
Week 13	Number Analyzed	24 participants	15 participants
		3.6 (1.3)	4.2 (1.6)

7. Secondary Outcome

Title	Patient's Global Assessment (PGA) of the Disease Activity
Description	Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
Time Frame	At baseline and week 13

Outcome Measure Data

Analysis Population Description

The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)

Arm/Group Title		S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:		S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Overall Number of Participants Analyzed		31	17
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	28 participants	17 participants
		7.1 (2.1)	7.1 (2.1)
Week 13	Number Analyzed	23 participants	13 participants
		6.2 (2.3)	5.4 (2.8)

8. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	Safety criterion
Time Frame	Through study completion, up to Week 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description:	S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Overall Number of Participants Analyzed	31	17
Measure Type: Count of Participants; Unit of Measure: Participants
Patients having reported at least one treatment emergent adverse event (TEAE)	24 77.4%	11 64.7%
Patients having reported at least one serious AE	3 9.7%	1 5.9%

Adverse Events

Time Frame	Through Week 28 (about 6 months)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
Arm/Group Description	S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.	S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
All-Cause Mortality
	S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/31 (0.00%)	0/17 (0.00%)
Serious Adverse Events
	S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/31 (9.68%)	1/17 (5.88%)
Blood and lymphatic system disorders
Lymphopenia † 1	1/31 (3.23%)	0/17 (0.00%)
Cardiac disorders
Cardiac failure † 1	0/31 (0.00%)	1/17 (5.88%)
Eye disorders
Amaurosis fugax † 1	1/31 (3.23%)	0/17 (0.00%)
General disorders
Vascular stent stenosis † 1	0/31 (0.00%)	1/17 (5.88%)
Infections and infestations
Herpes zoster † 1	1/31 (3.23%)	0/17 (0.00%)
1 Term from vocabulary, MedDRA (25.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	S95011 Concentrate for Solution for Infusion	S95011 Placebo Concentrate for Solution for Infusion
	Affected / at Risk (%)	Affected / at Risk (%)
Total	24/31 (77.42%)	11/17 (64.71%)
Blood and lymphatic system disorders
Lymphopenia † 1	4/31 (12.90%)	0/17 (0.00%)
Neutropenia † 1	1/31 (3.23%)	1/17 (5.88%)
Gastrointestinal disorders
Constipation † 1	1/31 (3.23%)	1/17 (5.88%)
Dry mouth † 1	0/31 (0.00%)	1/17 (5.88%)
Salivary gland pain † 1	0/31 (0.00%)	1/17 (5.88%)
General disorders
Discomfort † 1	0/31 (0.00%)	1/17 (5.88%)
Infections and infestations
COVID-19 † 1	5/31 (16.13%)	2/17 (11.76%)
Parotitis † 1	2/31 (6.45%)	1/17 (5.88%)
Oral Herpes † 1	2/31 (6.45%)	0/17 (0.00%)
Cystitis † 1	1/31 (3.23%)	1/17 (5.88%)
Nasopharyngitis † 1	1/31 (3.23%)	1/17 (5.88%)
Gastrointestinal Infection † 1	0/31 (0.00%)	1/17 (5.88%)
Onychomycosis † 1	0/31 (0.00%)	1/17 (5.88%)
Pharyngitis streptococcal † 1	0/31 (0.00%)	1/17 (5.88%)
Sialoadenitis † 1	0/31 (0.00%)	1/17 (5.88%)
Viral upper respiratory tract infection † 1	0/31 (0.00%)	1/17 (5.88%)
Injury, poisoning and procedural complications
Infusion related reaction † 1	1/31 (3.23%)	1/17 (5.88%)
Thermal burn † 1	0/31 (0.00%)	1/17 (5.88%)
Investigations
Blood cholesterol increased † 1	0/31 (0.00%)	1/17 (5.88%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/31 (3.23%)	1/17 (5.88%)
Myalgia † 1	1/31 (3.23%)	1/17 (5.88%)
Sjogren's syndrome † 1	0/31 (0.00%)	1/17 (5.88%)
Nervous system disorders
Presyncope † 1	0/31 (0.00%)	1/17 (5.88%)
Skin and subcutaneous tissue disorders
Purpura † 1	2/31 (6.45%)	0/17 (0.00%)
Acne † 1	0/31 (0.00%)	1/17 (5.88%)
Dermatitis † 1	0/31 (0.00%)	1/17 (5.88%)
Skin ulcer † 1	0/31 (0.00%)	1/17 (5.88%)
Vascular disorders
Hypertension † 1	2/31 (6.45%)	0/17 (0.00%)
1 Term from vocabulary, MedDRA (25.0); † 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.

Results Point of Contact

• Name/Title: Clinical Studies Department
• Organization: Institut de Recherches Internationales Servier (I.R.I.S.)
• Phone: +33 1 55 72 60 00
• EMail: scientificinformation@servier.com

• Responsible Party: Servier ( Institut de Recherches Internationales Servier )
• ClinicalTrials.gov Identifier: NCT04605978
• Other Study ID Numbers: CL2-95011-001; 2020-001526-59 ( EudraCT Number )
• First Submitted: October 19, 2020
• First Posted: October 28, 2020
• Results First Submitted: January 15, 2024
• Results First Posted: April 23, 2024
• Last Update Posted: April 23, 2024