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S95011 concentrate for solution for infusion for Sjögren's Syndrome

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
Awards & highlights

Study Summary

This trial is testing an experimental drug to see if it can reduce disease activity in people with primary Sjögren's syndrome.

Eligible Conditions
  • Sjögren's Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week 4 and week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 4 and week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ESSDAI total score
Secondary outcome measures
ESSDAI score by domain and total score
ESSPRI score by symptom and total score
Fatigue (MFI)
+4 more

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
86 Previous Clinical Trials
67,088 Total Patients Enrolled
ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,368 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must potential participants meet for this research endeavor?

"Patients aged 18 to 75 with primary Sjögren's Syndrome (pss) are currently being admitted in this clinical trial. Prospective participants must meet the American College of Rheumatology-EULAR criteria, have an ESSDAI total score ≥ 6 and at least 6 points scored within seven distinct domains, test positive for anti-Sjögrens Syndrome A antibodies or ANA ≥ 1:320/RF >20 IU/ml, and demonstrate a stimulated whole salivary flow rate that exceeds 0 mL per minute."

Answered by AI

What is the cap for individuals involved in this trial?

"Affirmative. According to the information uploaded on clinicaltrials.gov, this experiment is currently enlisting participants. The trial was posted in August of 2021 and saw its most recent update at the end of November 2022 - it intends to recruit 45 people from 8 different locations."

Answered by AI

Is this research endeavor accommodating individuals aged 30 and above?

"This experiment is seeking individuals with ages surpassing the age of consent and below 75 years old."

Answered by AI

Is this research endeavor currently accepting participants?

"Based on the information available at clinicaltrials.gov, this medical trial is actively searching for participants. This research project was initially published on August 3rd 2021 and has been recently updated as of November 30th 2022."

Answered by AI

Has the FDA approved S95011 concentrate for solution for infusion?

"Our experts at Power rated S95011 concentrate for solution for infusion a 2 on the scale of 1 to 3 due to Phase 2 trial data only partially supporting its safety, yet lacking evidence of efficacy."

Answered by AI

How many facilities are involved with this trial's implementation?

"Patients are being sought out for this clinical trial at Altoona Center of Clinical Research in Duncansville, Pennsylvania, Wallace Rheumatic Study Centre situated in Beverly Hills, California and Colorado Arthritis Associates located in Lakewood. In addition to these sites there are 8 other places taking part."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
2021. "Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04605978.
~13 spots leftby Apr 2025
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