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New treatment option for Inclusion Body Myositis, Sporadic
Official title Ruxolitinib Treatment in Inclusion Body Myositis
ClinicalTrials.gov ID: NCT06536166
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as a twice-daily injection into a muscle, being studied as a potential treatment for inclusion body myositis, sporadic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Refer to the "Detailed Description" section.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join 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...
- 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 likely can't join 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
See the full eligibility 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...
- 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
- 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 treatment study involving human participants or in the exclusion period at the...
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France, France
- Bayonne, France, France
- Besançon, France, France
- Bordeaux, France, France
- Brest, France, France
- Bron, France, France
- Caen, France, France
- Créteil, France, France
- Garches, France, France
- Lille, France, France
- Limoges, France, France
- Marseille, France, France
- Montpellier, France, France
- Nancy, France, France
- Nantes, France, France
- Nice, France, France
- Paris, France, France
- Reims, France, France
- Saint-Etienne, France, France
- Strasbourg, France, France
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France, France; Bayonne, France, France; Besançon, France, France; Bordeaux, France, France; Brest, France, France; Bron, France, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.