Ruxolitinib Treatment in Inclusion Body Myositis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06536166
Phase
PHASE2
Status
Recruiting
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Conditions

  • Inclusion Body Myositis, Sporadic

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    IBM patients treated by ruxolitinib (JAKAVI®), 15mg per os, twice a day, during 12 months.
  • Placebo — DRUG
    IBM patients treated by placebo, twice a day, during 12 months.

Study Details

Refer to the "Detailed Description" section.

Key Dates

Start date
May 27, 2025
Status verified
Sep 2025
Primary completion
Jun 10, 2028
Completion
Sep 10, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Randomization in experimental group.
  • Placebo Comparator: Control group
    Randomization in control group.

Primary Outcome Measure

6 minutes-walk distance (6MWT): A distance walked in 6 min. superior in treated patients compared to placebo group [ Time Frame: 12 months ]

Central Contacts