Ruxolitinib Treatment in Inclusion Body Myositis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Inclusion Body Myositis, Sporadic

In brief

Refer to the "Detailed Description" section.

Key facts

Study ID

NCT06536166

Run by

Assistance Publique - Hôpitaux de Paris

People needed

80

Starts

2025-05-27

Expected to finish

2028-09-10

Last updated by the study team

2026-05-29

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hôpital Pierre-Paul Riquet, CHU de Toulouse — Toulouse, France, France (enrolling)
• CHU Caen Normandie — Caen, France, France (enrolling)
• Hôpital Henri-Mondor, APHP — Créteil, France, France (enrolling)
• Hôpital Roger Salengro, CHU de Lille — Lille, France, France (enrolling)
• Hôpital Dupuytren, CHU de Limoges — Limoges, France, France (enrolling)
• CHU Nancy — Nancy, France, France (enrolling)
• Hôpital Pasteur, CHU de Nice — Nice, France, France (enrolling)
• Hôpital Pitié-Salpêtrière, APHP — Paris, France, France (enrolling)
• Hôpital Christian Cabrol, CHU Reims — Reims, France, France (enrolling)
• Hôpital Bellevue, CHU Saint-Etienne — Saint-Etienne, France, France (enrolling)
• Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg — Strasbourg, France, France
• Hôpital de la Timone, APHM — Marseille, France, France
• Centre hospitalier de la Côte Basque — Bayonne, France, France
• Hôpital CHU Jean Minjoz, CHU Besançon — Besançon, France, France
• Hôpital Pellegrin - Tripode, CHU de Bordeaux — Bordeaux, France, France
• Hôpital de la Cavale Blanche, CHU de Brest — Brest, France, France
• Hôpital Pierre Wertheimer, CHU de Lyon — Bron, France, France
• Hôpital Gui de Chauliac, CHU de Montpellier — Montpellier, France, France
• CHU d'Angers — Angers, France, France
• Hôpital Raymond Poincaré, APHP — Garches, France, France
• Hôtel-Dieu, CHU Nantes — Nantes, France, France

Full record on ClinicalTrials.gov

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