Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug trial aims to ease skin hardening in rare autoimmune disease

NCT ID NCT04789850

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether itacitinib is safe and effective for adults with systemic sclerosis, a disease that causes skin thickening and organ damage. About 74 participants with early or active disease will receive the drug or a placebo for one year. The main goal is to see if it reduces skin thickness, measured by a standard scoring method.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Systemic sclerosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    46 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ambroise Paré hospital

    RECRUITING

    Boulogne-Billancourt, 92100, France

  • Avicenne Hospital

    RECRUITING

    Bobigny, 93022, France

  • CH Amiens

    RECRUITING

    Amiens, 80000, France

  • CH Dax-Côte d'ARgent

    RECRUITING

    Dax, 40100, France

  • CH Le Mans

    RECRUITING

    Le Mans, 72037, France

  • CH Valenciennes

    RECRUITING

    Valenciennes, 59300, France

  • CH de Cornouaille

    RECRUITING

    Quimper, 29000, France

  • CHU Angers

    RECRUITING

    Angers, 49100, France

  • CHU Annecy

    RECRUITING

    Annecy, 74370, France

  • CHU Besançon

    RECRUITING

    Besançon, 25030, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • CHU Caen

    RECRUITING

    Caen, 14000, France

  • CHU Dijon

    RECRUITING

    Dijon, 21000, France

  • CHU Gabriel Montpied

    RECRUITING

    Clermont-Ferrand, 63000, France

  • CHU Grenoble

    RECRUITING

    Grenoble, 38700, France

  • CHU Grenoble

    RECRUITING

    Grenoble, 38700, France

  • CHU Lille

    RECRUITING

    Lille, 59000, France

  • CHU Limoges

    RECRUITING

    Limoges, 87000, France

  • CHU Lyon sud

    RECRUITING

    Lyon, 69310, France

  • CHU Montpellier - St Eloi Hospital

    RECRUITING

    Montpellier, 34090, France

  • CHU Montpellier - rhumatology

    RECRUITING

    Montpellier, 34090, France

  • CHU Nancy

    RECRUITING

    Nancy, 54035, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86021, France

  • CHU Rouen

    NOT_YET_RECRUITING

    Rouen, 76000, France

  • CHU Saint Etienne

    RECRUITING

    Saint-Etienne, 42000, France

  • CHU Tours

    RECRUITING

    Tours, 37000, France

  • Cochin Hospital

    RECRUITING

    Paris, 75014, France

  • Henry Mondor hospital

    RECRUITING

    Créteil, 94000, France

  • Hopital L'Archet 1

    RECRUITING

    Nice, 06000, France

  • Hospital Croix St Simon

    NOT_YET_RECRUITING

    Paris, 75020, France

  • Hospital Pasteur - CHU Nice

    RECRUITING

    Nice, 06000, France

  • Hôpital Nord

    RECRUITING

    Marseille, 13015, France

  • Hôpital Sud

    RECRUITING

    Rennes, 35200, France

  • Hôpital de la Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • Hôpitaux de Barbois

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • La Pitié-Salpêtrière

    RECRUITING

    Paris, 75013, France

  • La Pitié-Salpêtrière

    RECRUITING

    Paris, 75013, France

  • La Timone Hospital

    RECRUITING

    Marseille, 13385, France

  • La Timone Hospital

    RECRUITING

    Marseille, 13385, France

  • Nouvel Hospital Civil

    RECRUITING

    Strasbourg, 67000, France

  • Rangueil Hospital

    RECRUITING

    Toulouse, 31400, France

  • Robert Debré Hospital

    RECRUITING

    Reims, 51100, France

  • Robert Schuman Hospital

    RECRUITING

    Metz, 57000, France

  • Saint Antoine Hospital

    NOT_YET_RECRUITING

    Paris, 75012, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.