Actively Recruiting
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)
Led by GlaxoSmithKline · Updated on 2025-12-09
514
Participants Needed
10
Research Sites
263 weeks
Total Duration
On this page
Sponsors
G
GlaxoSmithKline
Lead Sponsor
I
ICON plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Completed 52 weeks in parent study 218224 or 221672 without treatment failure
- Have systemic sclerosis-associated interstitial lung disease (SSc-ILD) or other connective tissue disease-associated ILD (CTD-ILD)
- For SSc participants, have skin areas suitable for subcutaneous injection in abdomen or thigh
- Able and willing to self-administer study medication or have a caregiver who can
- Female participants must not be pregnant or breastfeeding
- Female participants of childbearing potential must use highly effective contraception during treatment and for 4 months after last dose
- Female participants of childbearing potential must have a negative pregnancy test within 24 hours before first dose
- Capable of giving signed informed consent and complying with study requirements
You will not qualify if you...
- Discontinued study treatment before Week 52 in parent study 218224 or 221672
- Have significant, unstable, or uncontrolled acute or chronic diseases unrelated to SSc or CTD
- Experienced adverse events in parent studies that pose undue risk
- Have other medical conditions or lab abnormalities that affect drug absorption or safety
- Exposed to ionizing radiation over 10 mSv in past 3 years from work or research
- QTc interval greater than 480 milliseconds at Week 52 in parent study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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