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.
• 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