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NCT05878717 · ClinicalTrials.gov registry record · Phase 2
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
A Phase 2 study of Scleroderma, Systemic and Systemic Sclerosis Associated Interstitial Lung Disease, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05878717: Recruiting Phase 2 study of Scleroderma, Systemic and Systemic Sclerosis Associated Interstitial Lung Disease, sponsored by GlaxoSmithKline.
NCT05878717 is a Phase 2 study of Scleroderma, Systemic and Systemic Sclerosis Associated Interstitial Lung Disease that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 300 participants, above the 34-participant average among 6 other Scleroderma, Systemic trials with a reported enrollment target (782% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05878717, a Phase 2 study of Scleroderma, Systemic and Systemic Sclerosis Associated Interstitial Lung Disease, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Belimumab
Study Locations (20)
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Scottsdale
- GSK Investigational Site - Scottsdale
- GSK Investigational Site - Tucson
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Upland
New York
- GSK Investigational Site - New York
- GSK Investigational Site - New York
- GSK Investigational Site - Potsdam
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Miami
Colorado
- GSK Investigational Site - Aurora
District of Columbia
- GSK Investigational Site - Washington D.C.
Illinois
- GSK Investigational Site - Chicago
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-09-13 |
| Est. Completion | 2029-07-12 |
| Phase | Phase 2 |
What NCT05878717 shows while recruiting
NCT05878717 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 34-participant average among 6 other Scleroderma, Systemic trials with a reported enrollment target (782% higher).
The record links to 2 conditions, with Scleroderma, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05878717 names 20 study sites across 11 states, led by Arizona, California, New York.
Frequently Asked Questions
What is clinical trial NCT05878717 about?
NCT05878717 is a clinical study titled "A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease". This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as w...
What is the current status of trial NCT05878717?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2023-09-13. Estimated completion is 2029-07-12.
What conditions does trial NCT05878717 study?
This clinical trial studies the following conditions: Scleroderma, Systemic, Systemic Sclerosis Associated Interstitial Lung Disease.
What interventions are being tested in trial NCT05878717?
The interventions under investigation include: Placebo (OTHER), Belimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05878717?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05878717 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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