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Evaluating Itacitinib for treating adults with systemic sclerosis

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

Phase 2 Interventional Assistance Publique - Hôpitaux de Paris · NCT04789850

This study is testing if a new medication called itacitinib can help adults with systemic sclerosis feel better and reduce skin thickening.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment74 (estimated)
Ages18 Years and up
SexAll
SponsorAssistance Publique - Hôpitaux de Paris Academic / other
Drugs / interventionsrituximab, tocilizumab, itacitinib, methotrexate, cyclophosphamide
Locations46 sites (Amiens and 45 other locations)
Trial IDNCT04789850 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of diffuse systemic sclerosis and specific disease activity criteria.

Not a fit: Patients with limited systemic sclerosis or those with a disease duration exceeding 36 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and disease outcomes for patients with systemic sclerosis.

How similar studies have performed: Previous studies have indicated the involvement of the JAK-STAT pathway in systemic sclerosis, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Amiens and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic SclerosisSystemic sclerosisItacitinib
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.