AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Ruxolitinib Treatment in Inclusion Body Myositis

RecruitingPhase 2Ages 45 Years - anyAllAssistance Publique - Hôpitaux de Paris
💬

In plain words

What the trial is, and whether it could suit you

Refer to the "Detailed Description" section.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • Ruxolitinib
  • Placebo
📍

Where

21 sites
CHU d'Angers
Angers, France
Centre hospitalier de la Côte Basque
Bayonne, France
Hôpital CHU Jean Minjoz, CHU Besançon
Besançon, France
Hôpital Pellegrin - Tripode, CHU de Bordeaux
Bordeaux, France
Hôpital de la Cavale Blanche, CHU de Brest
Brest, France
Hôpital Pierre Wertheimer, CHU de Lyon
Bron, France
CHU Caen Normandie
Caen, France
Hôpital Henri-Mondor, APHP
Créteil, France

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy