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COMPLETED Phase 2

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

NCT02921971 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 97 participants
Start Date 2016-12-21
Est. Completion 2019-04-01
Phase Phase 2

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02921971

The ClinicalTrials.gov registry entry for NCT02921971 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02921971 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02921971?

The interventions under investigation include: Placebo (DRUG), SAR156597 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02921971?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial