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RECRUITING
NCT06716606
PHASE3

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)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: An Open Label 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

514

Start Date

2024-12-12

Completion Date

2030-10-23

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Belimumab

Belimumab will be administered.

Locations (41)

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Santa Fe, Argentina

GSK Investigational Site

Fitzroy, Victoria, Australia

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Mianyang, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shenyang, China

GSK Investigational Site

Zhuzhou, China

GSK Investigational Site

Toulouse, France

GSK Investigational Site

Larissa, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Poria – Neve Oved, Israel, Israel

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Gunma, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Tokushima, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Yamanashi, Japan

GSK Investigational Site

Bucheon Kyunggi-Do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Kyunggi-do, South Korea

GSK Investigational Site

Yongsan-Ku Seoul, South Korea

GSK Investigational Site

Bilbao, Bizkaia, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

VigoPontevedra, Spain

GSK Investigational Site

Leeds, United Kingdom

GSK Investigational Site

London, United Kingdom