Status:
RECRUITING
Ruxolitinib Treatment in Inclusion Body Myositis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Inclusion Body Myositis, Sporadic
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
Refer to the "Detailed Description" section.
Detailed Description
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of Ruxolitinib in the Treatment of Subjects with Inclusion Body Myositis (IBM) IBM i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06536166
Start Date
May 27 2025
End Date
September 10 2028
Last Update
October 3 2025
Active Locations (16)
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1
Hôpital Pellegrin - Tripode, CHU de Bordeaux
Bordeaux, France, France, 33076
2
Hôpital Pierre Wertheimer, CHU de Lyon
Bron, France, France, 69500
3
CHU Caen Normandie
Caen, France, France, 14000
4
Hôpital Henri-Mondor, APHP
Créteil, France, France, 94010