NCT06536166

Brief Summary

Refer to the "Detailed Description" section.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
27mo left

Started May 2025

Typical duration for phase_2

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
May 2025Sep 2028

First Submitted

Initial submission to the registry

July 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

May 27, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2028

Last Updated

May 29, 2026

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

July 26, 2024

Last Update Submit

May 27, 2026

Conditions

Inclusion Body Myositis, Sporadic

Keywords

Inclusion body myositisIdiopathic immune myopathyJAK-inhibitorRuxolitinib

Outcome Measures

Primary Outcomes (1)

  • 6 minutes-walk distance (6MWT): A distance walked in 6 min. superior in treated patients compared to placebo group

    The 6MWT is performed in a corridor, between two cones separated by a distance of 25 m.

    12 months

Secondary Outcomes (8)

  • Adverse events (safety and tolerability) of ruxolitinib in IBM patients

    Through study completion that is to say 15 months

  • Therapeutic muscular efficacy of ruxolitinib on muscle strength

    Until last consultation that is to say 12 months

  • Therapeutic muscular efficacy of ruxolitinib on overall muscle status

    Until last consultation that is to say 12 months

  • Respiratory ability

    12 months

  • Evaluate swallowing using Swallowing Disturbance Questionnaire (SDQ)

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Randomization in experimental group.

Drug: Ruxolitinib

Control group

PLACEBO COMPARATOR

Randomization in control group.

Drug: Placebo

Interventions

RuxolitinibDRUG

IBM patients treated by ruxolitinib (JAKAVI®), 15mg per os, twice a day, during 12 months.

Experimental group
PlaceboDRUG

IBM patients treated by placebo, twice a day, during 12 months.

Control group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CHU d'Angers

Angers, France, 49100, France

ENROLLING BY INVITATION

Centre hospitalier de la Côte Basque

Bayonne, France, 64109, France

ENROLLING BY INVITATION

Hôpital CHU Jean Minjoz, CHU Besançon

Besançon, France, 25030, France

ENROLLING BY INVITATION

Hôpital Pellegrin - Tripode, CHU de Bordeaux

Bordeaux, France, 33076, France

ACTIVE NOT RECRUITING

Hôpital de la Cavale Blanche, CHU de Brest

Brest, France, 29200, France

ENROLLING BY INVITATION

Hôpital Pierre Wertheimer, CHU de Lyon

Bron, France, 69500, France

ACTIVE NOT RECRUITING

CHU Caen Normandie

Caen, France, 14000, France

RECRUITING

Hôpital Henri-Mondor, APHP

Créteil, France, 94010, France

RECRUITING

Hôpital Raymond Poincaré, APHP

Garches, France, 92380, France

ACTIVE NOT RECRUITING

Hôpital Roger Salengro, CHU de Lille

Lille, France, 59037, France

RECRUITING

Hôpital Dupuytren, CHU de Limoges

Limoges, France, 87000, France

RECRUITING

Hôpital de la Timone, APHM

Marseille, France, 13005, France

NOT YET RECRUITING

Hôpital Gui de Chauliac, CHU de Montpellier

Montpellier, France, 34000, France

ENROLLING BY INVITATION

CHU Nancy

Nancy, France, 54035, France

RECRUITING

Hôtel-Dieu, CHU Nantes

Nantes, France, 44093, France

ACTIVE NOT RECRUITING

Hôpital Pasteur, CHU de Nice

Nice, France, 06001, France

RECRUITING

Hôpital Pitié-Salpêtrière, APHP

Paris, France, 75013, France

RECRUITING

Hôpital Christian Cabrol, CHU Reims

Reims, France, 51100, France

RECRUITING

Hôpital Bellevue, CHU Saint-Etienne

Saint-Etienne, France, 42270, France

RECRUITING

Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67089, France

ACTIVE NOT RECRUITING

Hôpital Pierre-Paul Riquet, CHU de Toulouse

Toulouse, France, 31059, France

RECRUITING

MeSH Terms

Conditions

Myositis, Inclusion Body

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • François Jérôme AUTHIER, Pr

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

François Jérôme AUTHIER, Pr

CONTACT

+33 1 4981 2735francois-jerome.authier@aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 2, 2024

Study Start

May 27, 2025

Primary Completion (Estimated)

June 10, 2028

Study Completion (Estimated)

September 10, 2028

Last Updated

May 29, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Datas are own by assistance publique - hopitaux de paris, please contact sponsor for further information.

Locations

FR(21)