Informations générales (source: ClinicalTrials.gov)
Blocking Interferon-γ by Ruxolitinib for Treating Inclusion Body Myositis: a Phase IIb Trial
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2025
septembre 2028
02 décembre 2025
Refer to the "Detailed Description" section.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:38:16 | Contacter | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Raymond Poincaré | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Caen Normandie - 14000 - Caen 3029241 - France - France | Contact (sur clinicalTrials) | ||||
| Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg - 67089 - Strasbourg 2973783 - France - France | Aleksandra NADAJ PAKLEZA, Dr. | Contact (sur clinicalTrials) | |||
| Hôpital Pasteur, CHU de Nice - 06001 - Nice 2990440 - France - France | Sabrina SACCONI, Pr. | Contact (sur clinicalTrials) | |||
| Hôpital Pierre Wertheimer, CHU de Lyon - 69500 - Bron 3029931 - France - France | 13/12/2025 07:38:15 | Contact (sur clinicalTrials) | |||
| Hôpital Pierre-Paul Riquet, CHU de Toulouse - 31059 - Toulouse 2972315 - France - France | Pascal CINTAS, Dr. | Contact (sur clinicalTrials) | |||
| Hôpital Roger Salengro, CHU de Lille - 59037 - Lille 2998324 - France - France | Céline TARD, Dr. | 13/12/2025 07:38:15 | Contact (sur clinicalTrials) | ||
| Hôtel-Dieu, CHU Nantes - 44093 - Nantes 2990969 - France - France | Armelle MAGOT, Dr. | 13/12/2025 07:38:14 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Nancy - 54035 - Nancy 2990999 - France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Bellevue, CHU Saint-Etienne - 42270 - Saint-Etienne 2980291 - France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Christian Cabrol, CHU Reims - 51100 - Reims 2984114 - France - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone, APHM - 13005 - Marseille 2995469 - France - France | Shahram ATTARIAN, Pr. | Contact (sur clinicalTrials) | |||
| Hôpital Dupuytren, CHU de Limoges - 87000 - Limoges 2998286 - France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pellegrin - Tripode, CHU de Bordeaux - 33076 - Bordeaux 3031582 - France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pitié-Salpêtrière, APHP - 75013 - Paris 2988507 - France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Raymond Poincaré, APHP - 92380 - Garches 3016675 - France - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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.