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
    Primary completion date:
    2029-27-12
    Observational study model:
    Not applicable
    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
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    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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