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NCT06716606 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
A Phase 3 study of Connective Tissue Diseases, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
- 10
- Study locations
NCT06716606: Recruiting Phase 3 study of Connective Tissue Diseases, sponsored by GlaxoSmithKline.
NCT06716606 is a Phase 3 study of Connective Tissue Diseases that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 514 participants, above the 33-participant average among 5 other Connective Tissue Diseases trials with a reported enrollment target (1458% higher). The trial reports 10 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06716606, a Phase 3 study of Connective Tissue Diseases, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 514 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the decline in lung function in participants with interstitial lung disease associated with diffuse cutaneous systemic sclerosis (dcSSc-ILD) and interstitial lung disease associated with other connective tissue diseases (CTD-ILD), respectively. The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.
Conditions Studied
Interventions
- DRUG Belimumab
Study Locations (10)
Other
- GSK Investigational Site - Ciudad Autonoma Buenos Aires
- GSK Investigational Site - Ciudad Autonoma de Buenos Aire
- GSK Investigational Site - Beijing
- GSK Investigational Site - Zhuzhou
- GSK Investigational Site - Larissa
- GSK Investigational Site - Hokkaido
- GSK Investigational Site - Tokyo
- GSK Investigational Site - Yongsan-Ku Seoul
- GSK Investigational Site - London
Pennsylvania
- GSK Investigational Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2029-12-27 |
| Phase | Phase 3 |
What NCT06716606 shows while recruiting
NCT06716606 is an interventional study that assigns participants to a tested intervention. The registered 514 participants enrollment target is mid-sized for trials with a published cap, above the 33-participant average among 5 other Connective Tissue Diseases trials with a reported enrollment target (1458% higher).
The record links to 1 condition, with Connective Tissue Diseases appearing as the primary indexed condition, and to 1 intervention - of which Belimumab is the first listed.
NCT06716606 lists 10 locations in 2 states (Other, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06716606 about?
NCT06716606 is a clinical study titled "A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)". This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the decline in lung function in participants with interstitial lung disease assoc...
What is the current status of trial NCT06716606?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2024-12-12. Estimated completion is 2029-12-27.
What conditions does trial NCT06716606 study?
This clinical trial studies the following conditions: Connective Tissue Diseases.
What interventions are being tested in trial NCT06716606?
The interventions under investigation include: Belimumab (DRUG).
Who is sponsoring clinical trial NCT06716606?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06716606 being conducted?
This trial has 10 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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