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NCT02921971 · ClinicalTrials.gov registry record · Phase 2
Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
A Phase 2 study of Systemic Sclerosis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 20
- Study locations
NCT02921971: Completed Phase 2 study of Systemic Sclerosis, sponsored by Sanofi.
NCT02921971 is a Phase 2 study of Systemic Sclerosis that has completed, run by Sanofi. The registered enrollment target is 97 participants, below the 275-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02921971, a Phase 2 study of Systemic Sclerosis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives: * To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc. * To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc. * To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc. * To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc. * To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.
Primary Outcome
mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score i
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAR156597
Study Locations (20)
Other
- Investigational Site Number 0320003 - Buenos Aires
- Investigational Site Number 0320002 - Caba
- Investigational Site Number 0320005 - Capital Federal
- Investigational Site Number 0320001 - San Miguel de Tucumán
- Investigational Site Number 0560001 - Ghent
- Investigational Site Number 0560002 - Leuven
- Investigational Site Number 2330001 - Tallinn
- Investigational Site Number 2500003 - Montpellier
- Investigational Site Number 2500004 - Paris
- Investigational Site Number 2500002 - Strasbourg
- Investigational Site Number 2760003 - Bad Nauheim
- Investigational Site Number 2760001 - Berlin
- Investigational Site Number 2760002 - Cologne
- Investigational Site Number 2760004 - Ulm
- Investigational Site Number 3800004 - Genova
- Investigational Site Number 3800001 - Milan
California
- Investigational Site Number 8400006 - San Francisco
District of Columbia
- Investigational Site Number 8400005 - Washington D.C.
Ohio
- Investigational Site Number 8400002 - Cleveland
Texas
- Investigational Site Number 8400007 - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2016-12-21 |
| Est. Completion | 2019-04-01 |
| Phase | Phase 2 |
What the finished NCT02921971 record still lists
NCT02921971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 275-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Systemic Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02921971 names 20 study sites across 5 states, led by Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02921971 about?
NCT02921971 is a clinical study titled "Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis". Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives: * To evaluate the efficacy of SAR156597 compared to placebo on p...
What is the current status of trial NCT02921971?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2016-12-21. Estimated completion is 2019-04-01.
What conditions does trial NCT02921971 study?
This clinical trial studies the following conditions: Systemic Sclerosis.
What interventions are being tested in trial NCT02921971?
The interventions under investigation include: Placebo (DRUG), SAR156597 (DRUG).
Who is sponsoring clinical trial NCT02921971?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02921971 being conducted?
This trial has 20 study locations across California, District of Columbia, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02921971's enrollment target sits among peer trials
97 8th of 26 higher than 19 of 26 other Systemic Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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