RecruitingPhase 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)

United States, Argentina, China514 participantsStarted 2024-12-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.
✓. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
✓. Additional requirements for pregnancy testing during and after study intervention are located.
✓. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

What they're measuring

Number of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs)

Timeframe: Up to approximately 5 years

Trial details

NCT IDNCT06716606

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12-27

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More Connective Tissue Diseases trials