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NCT05799755 · ClinicalTrials.gov registry record · Phase 4
Myositis Interstitial Lung Disease Nintedanib Trial
A Phase 4 study of Myositis Associated Interstitial Lund Disease (MA-ILD), sponsored by Rohit Aggarwal, MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
- 10
- Study locations
NCT05799755: Completed Phase 4 study of Myositis Associated Interstitial Lund Disease (MA-ILD), sponsored by Rohit Aggarwal, MD.
NCT05799755 is a Phase 4 study of Myositis Associated Interstitial Lund Disease (MA-ILD) that has completed, run by Rohit Aggarwal, MD. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05799755, a Phase 4 study of Myositis Associated Interstitial Lund Disease (MA-ILD), has completed, sponsored by Rohit Aggarwal, MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
- 10
- Study locations
Study Summary
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).
Primary Outcome
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. The Impacts module yields a single Impacts score. Symptoms and Impacts scores are summed to yield a total L-PF score. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. Summary score range fro
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Standard of Care
- DRUG Nintedanib
Study Locations (10)
New York
- Columbia University Irving Medical Center - New York
- Northwell Health - New York
Alabama
- University of Alabama - Birmingham
Arizona
- Mayo Clinic Arizona - Scottsdale
Colorado
- National Jewish Health - Denver
Florida
- University of South Florida - Tampa
Illinois
- University of Chicago - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 4 |
What the finished NCT05799755 record still lists
NCT05799755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Myositis Associated Interstitial Lund Disease (MA-ILD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05799755 lists 10 locations in 9 states (New York, Alabama, Arizona).
Frequently Asked Questions
What is clinical trial NCT05799755 about?
NCT05799755 is a clinical study titled "Myositis Interstitial Lung Disease Nintedanib Trial". 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...
What is the current status of trial NCT05799755?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2023-08-01. Estimated completion is 2025-12-31.
What conditions does trial NCT05799755 study?
This clinical trial studies the following conditions: Myositis Associated Interstitial Lund Disease (MA-ILD).
What interventions are being tested in trial NCT05799755?
The interventions under investigation include: Placebo (DRUG), Standard of Care (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT05799755?
This trial is sponsored by Rohit Aggarwal, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05799755 being conducted?
This trial has 10 study locations across Alabama, Arizona, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05799755's enrollment target sits among peer trials
49 1323rd of 2000 higher than 671 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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