Trials / Recruiting
RecruitingNCT05878717
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Belimumab | Belimumab will be administered. |
| OTHER | Placebo | .Placebo will be administered. |
Timeline
- Start date
- 2023-09-13
- Primary completion
- 2029-05-17
- Completion
- 2029-07-12
- First posted
- 2023-05-26
- Last updated
- 2026-01-12
Locations
131 sites across 18 countries: United States, Argentina, Australia, Belgium, Brazil, China, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Mexico, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05878717. Inclusion in this directory is not an endorsement.