Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

• Adult patient (≥18 years old)

• Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,

• Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,

• Patient with a modified Rodnan skin score (mRSS) ≥ 10 and ≤ 35 units at screening,

• Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months' duration of the study,

• Patient able to give written informed consent prior to participation in the study,

• Affiliation to a social security scheme (profit or being entitled).

Exclusion Criteria:

• Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,

• Contra-indications to itacitinib or Janus kinase inhibitor,

• Failure to sign the informed consent or unable to consent

• Patient participating in another investigational therapeutic study,

• Current, or history of recurrent infections, including HBV, HCV, HIV,

• Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,

• Patient suspected not to be observant to the proposed treatments,

• Patient who have white blood cell count ≤ 4,000/mm3,

• Patient who have platelet count ≤ 100,000/mm3,

• Patients who have ALT or AST level greater that 3 times the upper limit of normal,

• Patient who have triglyceride level greater than 5g/L

• Pregnant or breastfeeding woman,

• Protected adults (including individual under guardianship by court order),

• Patient receiving or having received mycophenolate mofetil or methotrexate within the last month (possible inclusion beyond one month),

• Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),

• Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)