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Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
Phase 2
Waitlist Available
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week 4 and week 13
Summary
This trial is testing if giving a medication called S95011 can help reduce symptoms in people with primary Sjögren's syndrome, a condition where the immune system attacks moisture-producing glands.
Eligible Conditions
- Sjögren's Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, week 4 and week 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week 4 and week 13
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in ESSDAI Total Score
Secondary study objectives
ESSDAI Score by Domain and Total Score
ESSPRI Score by Symptom and Total Score
Fatigue (MFI)
+4 moreSide effects data
From 2023 Phase 2 trial • 48 Patients • NCT0460597816%
COVID-19
13%
Lymphopenia
6%
Parotitis
6%
Oral Herpes
6%
Purpura
6%
Hypertension
3%
Amaurosis fugax
3%
Herpes zoster
3%
Cystitis
3%
Neutropenia
3%
Infusion related reaction
3%
Nasopharyngitis
3%
Constipation
3%
Arthralgia
3%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
S95011 Placebo Concentrate for Solution for Infusion
S95011 Concentrate for Solution for Infusion
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: S95011 concentrate for solution for infusionExperimental Treatment1 Intervention
S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Group II: S95011 Placebo concentrate for solution for infusionPlacebo Group1 Intervention
S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S95011 concentrate for solution for infusion
2021
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Institut de Recherches Internationales ServierLead Sponsor
90 Previous Clinical Trials
67,021 Total Patients Enrolled
ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,286 Total Patients Enrolled