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New hope for rare muscle disease: drug targets inflammation to preserve walking ability

NCT ID NCT06536166

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ruxolitinib, a drug that blocks a specific immune signal (interferon-γ), can help people with inclusion body myositis, a rare muscle disease that causes progressive weakness. About 80 adults aged 45 and older will receive either the drug or a placebo. The main goal is to see if treated patients can walk farther in 6 minutes than those on placebo, while also checking for side effects.

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 80 people

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

Started

May 2025

Expected to finish

Sep 2028

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

45 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: * Age ≥ 45 years * Effective contraception for the duration of the clinical trial for fertile women of childbearing age * Defined diagnosis of IBM according to data-derived criteria (Llyod et al, 2014): Patient must fulfill the three following criteria for being diagnosed as IBM: (1) finger flexor or quadriceps weakness; and (2) muscle biopsy showing endomysial inflammation; and (3) muscle biopsy showing invasion of nonnecrotic muscle fibers or rimmed vacuoles * To be able to walk 6 min without assistance from another person (external assist devices permitted \[e.g., canes, walkers, or rollators\]) * Patient informed and having signed the consent for participation, possibly assisted by a trusted person Exclusion Criteria: * Pregnancy or breastfeeding * Patient under guardianship, curatorship, safeguard of justice or deprived of liberty * Patient with cognitive disorders or unable, according to the investigator, to understand the study and/or to give informed consent * Quadriceps weakness (manual muscle testing, MRC) below or equal 1 * Forced vital capacity (FVC) or forced expiratory volume (FEV) \< 50% of predicted value * Concomitant use of immunomodulatory drugs including previous treatment with JAK inhibitor, or medications acting on muscle anabolism or catabolism * Live vaccine within the 4 weeks before starting treatment * Comorbidity or active chronic disease which contraindicate ruxolitinib: * Lipid parameters abnormalities/elevations * Severe renal impairment (stage 4) and end-stage renal disease (stage 5) * Hepatic impairment * Cytopenia * Recent history (\<6 months) of cardiovascular or thromboembolic disease (documented coronaropathy or hospitalization for acute arterial thrombosis or stroke or deep venous thrombosis or pulmonary embolism) * Active smoking more than 20 pack-years or history of respiratory or skin cancer or recent history (\<6 months) of other neoplastic disease * Very high cardiovascular risk (red color) at SCORE 2 in case of recent history (\<6 months) of cardiovascular or thromboembolic disease and non-controlled cardiovascular risk factors * History of Stevens-Johnson's syndrome or Lyell's syndrome * Active SARS-CoV-2 infection (patient can be included once infection resolved) * Any medical condition which limits the ability of participant to participate in study * Necessity to use a drug incompatible with ruxolitinib * Hypersensitivity to the IMP's active substance (ruxolitinib) or to any of the excipients * Non-affiliation to a social security scheme or to another social protection scheme, patient on state medical aid * Foreseeable inability, according to the investigator, to participate in all the visits, treatments and measures provided for in the protocol * Concomitant participation in another clinical trial on medical product for human use, to a clinical investigation on a medical device, to interventional study involving human participants or in the exclusion period at the end of a previous clinical trial on medical product for human use, a clinical investigation on a medical device, or study involving human participants. Participation in non-interventional research is permitted.

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Conditions

The condition(s) this trial relates to.

inclusion body myositis

As listed by the trial registrant

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

Inclusion body myositis, sporadic

How to take part

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

  1. The places running it

    16 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

  • CHU Caen Normandie

    RECRUITING

    Caen, France, 14000, France

  • CHU Nancy

    RECRUITING

    Nancy, France, 54035, France

  • CHU d'Angers

    ENROLLING_BY_INVITATION

    Angers, France, 49100, France

  • Centre hospitalier de la Côte Basque

    ENROLLING_BY_INVITATION

    Bayonne, France, 64109, France

  • Hôpital Bellevue, CHU Saint-Etienne

    RECRUITING

    Saint-Etienne, France, 42270, France

  • Hôpital CHU Jean Minjoz, CHU Besançon

    ENROLLING_BY_INVITATION

    Besançon, France, 25030, France

  • Hôpital Christian Cabrol, CHU Reims

    RECRUITING

    Reims, France, 51100, France

  • Hôpital Dupuytren, CHU de Limoges

    RECRUITING

    Limoges, France, 87000, France

  • Hôpital Gui de Chauliac, CHU de Montpellier

    ENROLLING_BY_INVITATION

    Montpellier, France, 34000, France

  • Hôpital Henri-Mondor, APHP

    RECRUITING

    Créteil, France, 94010, France

  • Hôpital Pasteur, CHU de Nice

    RECRUITING

    Nice, France, 06001, France

  • Hôpital Pellegrin - Tripode, CHU de Bordeaux

    ACTIVE_NOT_RECRUITING

    Bordeaux, France, 33076, France

  • Hôpital Pierre Wertheimer, CHU de Lyon

    ACTIVE_NOT_RECRUITING

    Bron, France, 69500, France

  • Hôpital Pierre-Paul Riquet, CHU de Toulouse

    RECRUITING

    Toulouse, France, 31059, France

  • Hôpital Pitié-Salpêtrière, APHP

    RECRUITING

    Paris, France, 75013, France

  • Hôpital Raymond Poincaré, APHP

    ACTIVE_NOT_RECRUITING

    Garches, France, 92380, France

  • Hôpital Roger Salengro, CHU de Lille

    RECRUITING

    Lille, France, 59037, France

  • Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

    ACTIVE_NOT_RECRUITING

    Strasbourg, France, 67089, France

  • Hôpital de la Cavale Blanche, CHU de Brest

    ENROLLING_BY_INVITATION

    Brest, France, 29200, France

  • Hôpital de la Timone, APHM

    NOT_YET_RECRUITING

    Marseille, France, 13005, France

  • Hôtel-Dieu, CHU Nantes

    ACTIVE_NOT_RECRUITING

    Nantes, France, 44093, France