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

Phase 2

Active, not recruiting

• Conditions: Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening

• Registration Number: 2024-513648-27-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-30
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• 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 -		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
  

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in modified Rodnan skin score at 360 days		The primary outcome is the change in modified Rodnan skin score at 360 days

Secondary Outcome Measures

Name	Time	Method
Security profile; SSc disease activity; Quality of life and disability		Security profile; SSc disease activity; Quality of life and disability

Trial Locations

Locations (33)

Centre Hospitalier Universitaire Grenoble Alpes; 🇫🇷 La Tronche, France

Centre Hospitalier De Dax Cote D'Argent; 🇫🇷 Dax, France

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

Centre Hospitalier Universitaire De Nice; 🇫🇷 Nice, France

Centre Hospitalier Universitaire De Dijon; 🇫🇷 Dijon, France

Hospices Civils De Lyon; 🇫🇷 Pierre Benite, France

Centre Hospitalier Et Universitaire De Limoges; 🇫🇷 Limoges Cedex 1, France

Centre Hospitalier Regional De Marseille; 🇫🇷 Marseille, France

Centre Hospitalier Regional Universitaire De Tours; 🇫🇷 Tours, France

Centre Hospitalier Intercommunal De Cornouaille; 🇫🇷 Quimper Cedex, France

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Centre Hospitalier Universitaire Grenoble Alpes

🇫🇷La Tronche, France

Laurence BOUILLET

Site contact

0476766898

LBouillet@chu-grenoble.fr

Bernard IMBERT

Site contact

0476765361

bimbert@chu-grenoble.fr