What is belimumab studying for interstitial lung disease associated with systemic sclerosis and connective tissue diseases?

Belimumab is being studied to understand its long-term safety and whether it can slow lung function decline and disease progression in adults with ILD linked to systemic sclerosis and other connective tissue diseases. This research is sponsored by GlaxoSmithKline and continues from earlier clinical trials.

Who may be eligible for this connective tissue disease clinical trial?

Adults aged 18 years and older who have completed prior related studies without treatment failure may be eligible. Both males and females can participate, with females needing to meet specific pregnancy and contraception requirements. Participants should be able to self-administer or have assistance with the medication. Please review eligibility criteria for more details.

Is there any cost to participate in this connective tissue disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06716606

Long-term Study of Belimumab Treatment in Adults with Interstitial Lung Disease from Systemic Sclerosis or Other Connective Tissue Diseases

Led by GlaxoSmithKline · Updated on 2025-12-09

514

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term safety and effects of belimumab in adults with interstitial lung disease ILD linked to systemic sclerosis SSc and other connective tissue diseases CTD. This open-label extension study builds on previous randomized controlled trials to see if belimumab can continue to slow lung function decline, disease progression, and improve quality of life in these patients. Participants in this study will receive belimumab as the investigational treatment. The study continues from prior trials, focusing on long-term use and tolerance. Participants will be monitored over time to assess how well belimumab is tolerated and its impact on lung function and overall disease status. During the study, researchers will track adverse events, including serious and special interest events, for up to approximately five years. They will also measure changes in lung function using forced vital capacity FVC at multiple time points baseline, 12, 26, and 52 weeks. Participants will undergo regular assessments to monitor safety, disease progression, and quality of life throughout the study period.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants with SSc-ILD or other CTD-ILDs who completed study 218224 or 221672 through the Week 52 visit without treatment failure.
Participants with systemic sclerosis should have an area of uninvolved or mildly thickened skin suitable for subcutaneous injection at the abdomen or thigh.
Participants must be capable and willing to self-administer the study medication or have a caregiver/healthcare professional who can administer it.
Female participants must not be pregnant or breastfeeding and must meet specific contraception requirements if of childbearing potential.
Participants must be capable of giving signed informed consent and comply with study requirements.

You will not qualify if you...

Participants who discontinued study treatment prior to Week 52 in studies 218224 or 221672.
Participants with significant, unstable, or uncontrolled acute or chronic diseases not due to systemic sclerosis or CTD that may pose undue risk.
Participants with medical conditions or laboratory abnormalities that may alter drug metabolism, pose safety risks, interfere with data interpretation, or make continuation unsafe.
Participants exposed to ionizing radiation over 10 mSv above background in the past 3 years due to occupational or research exposure.
Participants with a QTc interval greater than 480 milliseconds at Week 52 of the parent studies.

Research Team

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

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