Last updated: 12/02/2025 06:20:17

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)

GSK study ID
219855
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

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

Secondary outcomes:

Change from Baseline in Forced Vital Capacity (FVC)

Timeframe: Baseline (Day 1 of OLE study) and at Weeks 12, 26 and 52

Interventions:
Drug: Belimumab
Enrollment:
514
Observational study model:
Not applicable
Primary completion date:
2029-27-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Connective Tissue diseases
Product
belimumab
Collaborators
ICON
Study date(s)
December 2024 to December 2029
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224 or 221672 through to and including the Week 52 visit and are not considered treatment failure, defined as meeting either of the following criteria:
  • Discontinuation of study medication during study 218224 or 221672 for any reason.
  • Participants of study 218224 or study 221672 who have discontinued study treatment, prior to Week 52.
  • Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, put the participant at undue risk.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Status
Recruiting
Location
GSK Investigational Site
Yongsan-Ku Seoul, South Korea
Status
Recruiting
Location
GSK Investigational Site
ZhuZhou, China, 412007
Status
Recruiting
Location
GSK Investigational Site
Hokkaido, Japan, 060-8648
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 113-8603
Status
Recruiting
Location
GSK Investigational Site
Beijing, China, 100020
Status
Recruiting
Location
GSK Investigational Site
Larissa, Greece, 41110
Status
Recruiting
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1425
Status
Recruiting
Location
GSK Investigational Site
Philadelphia, PA, United States, 19104
Status
Recruiting
Location
GSK Investigational Site
London, United Kingdom, NW3 2QG
Status
Recruiting

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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