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NCT06572384 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
A Phase 3 study of Lung Diseases, Interstitial, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
- 20
- Study locations
NCT06572384: Recruiting Phase 3 study of Lung Diseases, Interstitial, sponsored by GlaxoSmithKline.
NCT06572384 is a Phase 3 study of Lung Diseases, Interstitial that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 440 participants, below the 12,465-participant average among 10 other Lung Diseases, Interstitial trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06572384, a Phase 3 study of Lung Diseases, Interstitial, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
- 20
- Study locations
Study Summary
Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.
Primary Outcome
Forced vital capacity is the total amount of air exhaled during the lung function test. Low FVC (mL) reflects more impaired lung function. Absolute Change from Baseline in FVC will be reported.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Belimumab
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Upland
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Ciudad Autonoma Buenos Aires
New York
- GSK Investigational Site - New York
- GSK Investigational Site - New York
- GSK Investigational Site - Potsdam
Florida
- GSK Investigational Site - Gainesville
- GSK Investigational Site - Naples
Texas
- GSK Investigational Site - Houston
- GSK Investigational Site - Temple
Missouri
- GSK Investigational Site - St Louis
North Carolina
- GSK Investigational Site - Durham
Pennsylvania
- GSK Investigational Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2024-09-11 |
| Est. Completion | 2028-12-13 |
| Phase | Phase 3 |
What NCT06572384 shows while recruiting
NCT06572384 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 12,465-participant average among 10 other Lung Diseases, Interstitial trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Lung Diseases, Interstitial appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06572384 names 20 study sites across 9 states, led by California, Other, New York.
Frequently Asked Questions
What is clinical trial NCT06572384 about?
NCT06572384 is a clinical study titled "A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease". Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the ...
What is the current status of trial NCT06572384?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2024-09-11. Estimated completion is 2028-12-13.
What conditions does trial NCT06572384 study?
This clinical trial studies the following conditions: Lung Diseases, Interstitial.
What interventions are being tested in trial NCT06572384?
The interventions under investigation include: Placebo (OTHER), Belimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06572384?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06572384 being conducted?
This trial has 20 study locations across California, Florida, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06572384's enrollment target sits among peer trials
440 5th of 10 higher than 6 of 10 other Lung Diseases, Interstitial trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Diseases, Interstitial 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.
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