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)

Part of paid clinical trials in Los Angeles, California.

Sponsor
GlaxoSmithKline
Study ID
NCT06716606
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Connective Tissue Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belimumab — DRUG
    Belimumab will be administered.

Study Details

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.

Key Dates

First listed
Dec 4, 2024
Start date
Dec 12, 2024
Status verified
Sep 2026
Primary completion
Sep 27, 2030
Completion
Oct 23, 2030

Study Design

Enrollment
514 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Belimumab
    Participants will receive belimumab.

Primary Outcome Measure

Number of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs) [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90095
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Suzanne Kafaja (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew YorkNew York11201
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
David Goddard (PRINCIPAL_INVESTIGATOR)
GSK Investigational SitePhiladelphiaPennsylvania19104
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Chris Derk (PRINCIPAL_INVESTIGATOR)
GSK Investigational SitePhiladelphiaPennsylvania19140
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Gerard Criner (PRINCIPAL_INVESTIGATOR)

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By research site
GSK Investigational Site· Los Angeles, CAGSK Investigational Site· New York, NYGSK Investigational Site· Philadelphia, PA

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