Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-05-27
2028-09-10
Brief Summary
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Detailed Description
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Hypothesis/Objective : Ruxolitinib could be an effective therapy for IBM. Objective is to evaluate its therapeutic effects in IBM.
Method : Comparative, multicenter, randomized, parallel-group, superiority, placebo-controlled, double-blind, phase 2 trial. 60 IBM patients able to walk during at least 6mn will be randomized in two groups (30/group) and received either ruxolitinib 15mgx2/d or placebo during 1 yr. Evaluation includes 6MWT, muscle strength quantification, functional scales, respiratory functional test and muscle MRI.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group
Randomization in experimental group.
Ruxolitinib
IBM patients treated by ruxolitinib (JAKAVI®), 15mg per os, twice a day, during 12 months.
Control group
Randomization in control group.
Placebo
IBM patients treated by placebo, twice a day, during 12 months.
Interventions
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Ruxolitinib
IBM patients treated by ruxolitinib (JAKAVI®), 15mg per os, twice a day, during 12 months.
Placebo
IBM patients treated by placebo, twice a day, during 12 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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François Jérôme AUTHIER, Pr
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Pellegrin - Tripode, CHU de Bordeaux
Bordeaux, France, France
Hôpital Pierre Wertheimer, CHU de Lyon
Bron, France, France
CHU Caen Normandie
Caen, France, France
Hôpital Henri-Mondor, APHP
Créteil, France, France
Hôpital Raymond Poincaré, APHP
Garches, France, France
Hôpital Roger Salengro, CHU de Lille
Lille, France, France
Hôpital Dupuytren, CHU de Limoges
Limoges, France, France
Hôpital de la Timone, APHM
Marseille, France, France
CHU Nancy
Nancy, France, France
Hôtel-Dieu, CHU Nantes
Nantes, France, France
Hôpital Pasteur, CHU de Nice
Nice, France, France
Hôpital Pitié-Salpêtrière, APHP
Paris, France, France
Hôpital Christian Cabrol, CHU Reims
Reims, France, France
Hôpital Bellevue, CHU Saint-Etienne
Saint-Etienne, France, France
Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, France
Hôpital Pierre-Paul Riquet, CHU de Toulouse
Toulouse, France, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP220829
Identifier Type: -
Identifier Source: org_study_id
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