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Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

NCT02921971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2022-03-21

Study results available
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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

Interventions

DRUG

SAR156597

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-21
Primary Completion
2019-01-14
Completion
2019-04-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Estonia
  • France
  • Germany
  • Italy
  • Mexico
  • Poland
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921971 on ClinicalTrials.gov