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Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

NCT04789850 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-11-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.

Conditions

Interventions

DRUG

Itacitinib

200 mg oral for 360 days

DRUG

Placebo

200 mg oral for 360 days

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Luc Mouthon, MD-PhD · Assistance Publique - Hôpitaux de Paris

  • Benjamin Chaigne, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT04789850 on ClinicalTrials.gov