Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04789850
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    200 mg oral for 360 days
  • Placebo — DRUG
    200 mg oral for 360 days

Study Details

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

Key Dates

Start date
Feb 2, 2023
Status verified
Oct 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib
    200mg of oral Itacitinib everyday for 360 days.
  • Placebo Comparator: Placebo
    Oral placebo everyday for 360 days.

Primary Outcome Measure

Change in modified Rodnan skin score (mRSS) at 360 days [ Time Frame: 360 days ]

Central Contacts

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