Evaluating Itacitinib for treating adults with systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and efficacy of itacitinib, a Janus kinase inhibitor, in adults diagnosed with systemic sclerosis (SSc). SSc is a severe autoimmune disease characterized by skin fibrosis and potential visceral involvement, leading to significant disability and poor quality of life. The trial will involve adult participants with diffuse SSc and will measure the impact of itacitinib on disease activity and skin fibrosis. Participants will be randomly assigned to receive either itacitinib or a placebo over a specified duration.

Why it matters

Who can join: the full rules

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

Where it's running

• CH Amiens
  Amiens, France Recruiting
• CHU Angers
  Angers, France Recruiting
• CHU Annecy
  Annecy, France Recruiting
• CHU Besançon
  Besançon, France Recruiting
• Avicenne Hospital
  Bobigny, France Recruiting
• CHU Bordeaux
  Bordeaux, France Recruiting

Study contacts

• Principal investigator: Benjamin Chaigne, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Benjamin Chaigne, MD
• Email: benjamin.chaigne@aphp.fr
• Phone: +33 1 58 41 41 17

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.