Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536166
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Ruxolitinib Treatment in Inclusion Body Myositis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Blocking Interferon-γ by Ruxolitinib for Treating Inclusion Body Myositis a Phase IIb Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIGTIM
Brief Summary:
Refer to the Detailed Description section
Detailed Description:
A Phase IIIII 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 is the most frequent idiopathic immune myopathy IIM over age 45 pathologically characterized by the combination of intramuscular inflammation and degenerative features It differs from other IIMs by its chronic evolution and refractoriness to common immunomodulatory drugs leading to marked disability and poor quality of life Histological and molecular analyses of muscle biopsies from IBM patients showed intense muscular type II interferon IFNγ signature stronger than observed in other IIMs In vitro and in vivo experimental studies showed that IFNγ exerts myosuppressive effects through JAKSTAT pathway activation mimicking the degenerative features observed in IBM and that these effects can be prevented by JAK-inhibitor ruxolitinib
HypothesisObjective Ruxolitinib could be an effective therapy for IBM Objective is to evaluate its therapeutic effects in IBM
Method Comparative multicenter randomized parallel-group superiority placebo-controlled double-blind phase 2 trial 60 IBM patients able to walk during at least 6mn will be randomized in two groups 30group and received either ruxolitinib 15mgx2d or placebo during 1 yr Evaluation includes 6MWT muscle strength quantification functional scales respiratory functional test and muscle MRI
HypothesisObjective Ruxolitinib could be an effective therapy for IBM Objective is to evaluate its therapeutic effects in IBM
Method Comparative multicenter randomized parallel-group superiority placebo-controlled double-blind phase 2 trial 60 IBM patients able to walk during at least 6mn will be randomized in two groups 30group and received either ruxolitinib 15mgx2d or placebo during 1 yr Evaluation includes 6MWT muscle strength quantification functional scales respiratory functional test and muscle MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None