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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

25 Oct 2024 → 20 Nov 2025

Decision date (initial)

2024-07-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

French Ministry of Health : PHRC-N 2018

External identifiers

EU CT number

2024-513648-27-00

EudraCT number

2019-003430-16

ClinicalTrials.gov

NCT04789850

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 1

1. - to evaluate the safety of itacitinib in patients with SSc - to compare the efficacy of itacitinib versus placebo in terms of disease activity, quality of life and disability

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - 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 1

1. - 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome is the change in modified Rodnan skin score at 360 days

Secondary endpoints 1

1. Security profile; SSc disease activity; Quality of life and disability

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Benjamin CHAIGNE

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Benjamin CHAIGNE

Locations

1 EU/EEA country · 47 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Urgent safety measures 1 · Art. 54 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications