Actively Recruiting
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)
Led by GlaxoSmithKline · Updated on 2025-12-09
514
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GlaxoSmithKline
Lead Sponsor
I
ICON plc
Collaborating Sponsor
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
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to approximately 5 years
Participants receive belimumab and are monitored for safety and efficacy of the treatment.
Visits at Baseline and Weeks 12, 26, and 52
Trial Site Locations
Total: 10 locations
1
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Actively Recruiting
3
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1425
Actively Recruiting
4
GSK Investigational Site
Beijing, China, 100020
Actively Recruiting
5
GSK Investigational Site
Zhuzhou, China, 412007
Actively Recruiting
6
GSK Investigational Site
Larissa, Greece, 41110
Actively Recruiting
7
GSK Investigational Site
Hokkaido, Japan, 060-8648
Actively Recruiting
8
GSK Investigational Site
Tokyo, Japan, 113-8603
Actively Recruiting
9
GSK Investigational Site
Yongsan-Ku Seoul, South Korea
Actively Recruiting
10
GSK Investigational Site
London, United Kingdom, NW3 2QG
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here