Actively Recruiting

Phase 2
Age: 45Years +
All Genders
NCT06536166

Ruxolitinib Treatment in Inclusion Body Myositis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-10-03

80

Participants Needed

16

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Refer to the "Detailed Description" section.

CONDITIONS

Official Title

Ruxolitinib Treatment in Inclusion Body Myositis

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 years or older
  • Effective contraception during the trial for fertile women of childbearing age
  • Diagnosed with IBM by: finger flexor or quadriceps weakness; muscle biopsy showing endomysial inflammation; and biopsy showing invasion of nonnecrotic muscle fibers or rimmed vacuoles
  • Able to walk 6 minutes without assistance from another person (can use assistive devices like canes or walkers)
  • Provided informed consent to participate, possibly with help from a trusted person
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Under guardianship, curatorship, safeguard of justice, or deprived of liberty
  • Cognitive disorders or unable to understand the study or give consent
  • Quadriceps muscle strength less than or equal to 1 on manual muscle testing
  • Forced vital capacity or forced expiratory volume less than 50% of predicted
  • Using immunomodulatory drugs including previous JAK inhibitors, or muscle anabolic/catabolic medications
  • Received live vaccine within 4 weeks before treatment
  • Comorbidities contraindicating ruxolitinib including severe lipid abnormalities, severe kidney or liver impairment, cytopenia, recent serious cardiovascular or thromboembolic events, heavy smoking history, recent cancer, very high cardiovascular risk, history of Stevens-Johnson or Lyell's syndrome
  • Active COVID-19 infection (can be included after recovery)
  • Any medical condition limiting study participation
  • Need for medications incompatible with ruxolitinib
  • Allergy to ruxolitinib or its ingredients
  • Not covered by social security or medical aid
  • Expected inability to complete all visits, treatments, and assessments
  • Participation in another clinical trial involving medical products or devices recently or concurrently

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Hôpital Pellegrin - Tripode, CHU de Bordeaux

Bordeaux, France, France, 33076

Active, Not Recruiting

2

Hôpital Pierre Wertheimer, CHU de Lyon

Bron, France, France, 69500

Active, Not Recruiting

3

CHU Caen Normandie

Caen, France, France, 14000

Active, Not Recruiting

4

Hôpital Henri-Mondor, APHP

Créteil, France, France, 94010

Actively Recruiting

5

Hôpital Raymond Poincaré, APHP

Garches, France, France, 92380

Active, Not Recruiting

6

Hôpital Roger Salengro, CHU de Lille

Lille, France, France, 59037

Not Yet Recruiting

7

Hôpital Dupuytren, CHU de Limoges

Limoges, France, France, 87000

Active, Not Recruiting

8

Hôpital de la Timone, APHM

Marseille, France, France, 13005

Not Yet Recruiting

9

CHU Nancy

Nancy, France, France, 54035

Active, Not Recruiting

10

Hôtel-Dieu, CHU Nantes

Nantes, France, France, 44093

Not Yet Recruiting

11

Hôpital Pasteur, CHU de Nice

Nice, France, France, 06001

Actively Recruiting

12

Hôpital Pitié-Salpêtrière, APHP

Paris, France, France, 75013

Active, Not Recruiting

13

Hôpital Christian Cabrol, CHU Reims

Reims, France, France, 51100

Active, Not Recruiting

14

Hôpital Bellevue, CHU Saint-Etienne

Saint-Etienne, France, France, 42270

Active, Not Recruiting

15

Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, France, France, 67089

Not Yet Recruiting

16

Hôpital Pierre-Paul Riquet, CHU de Toulouse

Toulouse, France, France, 31059

Not Yet Recruiting

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Research Team

F

François Jérôme AUTHIER, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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