SCLERITA - Safety and efficacy of itacitinib in adults with systemic sclerosis: a phase II, randomized, controlled trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513648-27-00

Acronym

APHP180613

Enrollment

Registered

2024-07-30

Start date

2024-10-25

Completion date

2025-11-20

Last updated

2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening

Brief summary

The primary outcome is the change in modified Rodnan skin score at 360 days

Detailed description

Security profile; SSc disease activity; Quality of life and disability

Interventions

DRUGItacitinib

DRUGplacebo of itacitinib 100mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome is the change in modified Rodnan skin score at 360 days	—

Secondary

Measure	Time frame
Security profile; SSc disease activity; Quality of life and disability	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026