Myositis Interstitial Lung Disease Nintedanib Trial

ClinicalTrials.gov ID: NCT05799755

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Official title

Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung. This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices. The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine).

Study identification

NCT ID: NCT05799755
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: Rohit Aggarwal, MD; Other
Enrollment: 62 participants

Conditions and interventions

Conditions

Myositis Associated Interstitial Lund Disease (MA-ILD)

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 1, 2023 (Actual)
Primary completion: Mar 17, 2025 (Actual)
Completion: Dec 31, 2025 (Actual)
Last update posted: Oct 15, 2026

2023 – 2025

United States locations

U.S. sites: 10
U.S. states: 9
U.S. cities: 9

Facility	City	State	ZIP	Site status
University of Alabama	Birmingham	Alabama	35294	—
Mayo Clinic Arizona	Scottsdale	Arizona	85259	—
National Jewish Health	Denver	Colorado	80206	—
University of South Florida	Tampa	Florida	33612	—
University of Chicago	Chicago	Illinois	60637	—
University of Kansas Medical Center	Kansas City	Kansas	66160	—
Columbia University Irving Medical Center	New York	New York	10032	—
Northwell Health	New York	New York	11021	—
University of Pittsburgh	Pittsburgh	Pennsylvania	15216	—
University of Utah Health Sciences Center	Salt Lake City	Utah	84112	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05799755, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 15, 2026 · Synced Nov 13, 2026