Safety and Efficacy of Itacitinib in Adults with Systemic Sclerosis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called itacitinib to see if it is safe and effective for adults with systemic sclerosis, a condition that causes skin and internal organs to become thick and hard. The trial is currently recruiting adult participants, specifically those aged 18 and older who have been diagnosed with a specific type of systemic sclerosis called diffuse systemic sclerosis. To be eligible, participants should have had the disease for less than three years or be experiencing active symptoms, and their skin score should fall within a certain range.

If you decide to participate, you will undergo regular check-ups and tests to monitor your health during the study. It's important to note that there are some criteria that may exclude you from participating, such as having certain infections, serious health issues, or having received specific treatments recently. This trial could provide an opportunity to help advance treatment options for systemic sclerosis while contributing to important medical research.

Gender

ALL

Eligibility 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 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 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,
• • 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