Myositis Interstitial Lung Disease Nintedanib Trial

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Myositis Associated Interstitial Lund Disease (MA-ILD)
Interventions
DRUG

Nintedanib

Nintedanib 150 mg BID

DRUG

Placebo

Placebo comparator

DRUG

Standard of Care

Maximum of 2 standard of care immunosuppressant (IS) drugs are allowed, one being a glucocorticoid (GC) and the other being a non-GC IS drug OR 2 non-GC IS drugs in the event that the patient is not on a GC). The patient should be on the IS drug(s) for at least 12 weeks (at least 4 weeks or more for GC) before the screening. The doses should be stable for at least 4 weeks (at least 2 weeks for GC) before the screening visit.

Trial Locations (10)

10032

Columbia University Irving Medical Center, New York

11021

Northwell Health, New York

15216

University of Pittsburgh, Pittsburgh

33612

University of South Florida, Tampa

35294

University of Alabama, Birmingham

60637

University of Chicago, Chicago

66160

University of Kansas Medical Center, Kansas City

80206

National Jewish Health, Denver

84112

University of Utah Health Sciences Center, Salt Lake City

85259

Mayo Clinic Arizona, Scottsdale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

lead

Rohit Aggarwal, MD

OTHER

NCT05799755 - Myositis Interstitial Lung Disease Nintedanib Trial | Biotech Hunter | Biotech Hunter