Testing Itacitinib in Adults With Systemic Sclerosis

Trial details

Who runs it

Assistance Publique - Hôpitaux de Paris

Trial code

NCT04789850EU 2024-513648-27-00

Record updated

20 November 2025

Original description

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

Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial

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

Inclusion: 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 diffuse SSc, according to Leroy and Medsger dichotomy; 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); If patients receive mycophenolate or methotrexate for SSc, these need to be on stable dose as follows:; Mycophenolate mofetil/sodium: stable dose for at least 2 months prior to randomisation; Methotrexate: stable dose and route of administration for at least 2 months prior to randomisation.

Exclusion: Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,; Contra-indications to itacitinib or Janus kinase inhibitor,; 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); Failure to sign the informed consent or unable to consent; Acute or chronic active 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 with Systemic Lupus, or Sjögren's syndrome with systemic manifestations justifying immunosuppressive therapy; Atherosclerotic cardiovascular disease as defined by a history of myocardial infarction, ischaemic stroke, or peripheral artery thrombosis; Anti-phospholipid syndrome; 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 participating in another investigational therapeutic study,; Patient suspected not to be observant to the proposed treatments,; Patient who have triglyceride level greater than 5g/L; Pregnant or breastfeeding woman,; Protected adults (including individual under guardianship by court order),.

ClinicalTrials.gov NCT04789850 · EU CTIS 2024-513648-27-00