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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 74

Inclusion Criteria

Adult patient (>/= 18 years old), -Patient with a diagnosis of SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria, -Patient with a diagnosis of diffuse SSc, according to LeRoy and Medgser classification -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 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 -Patientparticipatinginanotherinvestigational therapeutic study, -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 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 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). -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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to show a decrease of skin fibrosis, as evaluated by the modified Rodnan skin score, after 360 days of treatment, in patients with diffuse SSc treated with itacitinib when compared to patients treated with a placebo;Secondary Objective: -to evaluate the safety of itacitinib in patients with SSc -to compare the efficacy of itacitinib versus placebo in terms of disease activity, quality of life and disability;Primary end point(s): The primary outcome is the change in modified Rodnan skin score at 360 days

Secondary Outcome Measures