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)

Last updated: December 2, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Musculoskeletal Diseases

Connective Tissue Diseases

Scar Tissue

Treatment

Belimumab

Clinical Study ID

NCT06716606
219855
2023-509370-39
2023-509370-39-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224or 221672 through to and including the Week 52 visit and are not consideredtreatment failure, defined as meeting either of the following criteria:

  • Discontinuation of study medication during study 218224 or 221672 for anyreason.

  • Participants with SSc should have an area of uninvolved or mildly thickened skinthat, in the opinion of the investigator, would allow subcutaneous (SC) injection atthe abdomen or the front, middle region of the thigh.

  • Participant is capable and willing to self-administer the study medication or has acaregiver/healthcare professional who is capable and willing to administer the studymedication throughout the study.

  • Female participants: A female participant is eligible to participate if she is notpregnant or breastfeeding, and one of the following conditions applies:

Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.

  1. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, asrequired by local regulations) within 24 hours before the first dose of studyintervention.

  2. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serumpregnancy test is required. In such cases, the participant must be excluded fromparticipation if the serum pregnancy result is positive.

  3. Additional requirements for pregnancy testing during and after study interventionare located.

  4. The investigator is responsible for review of medical history, menstrual history,and recent sexual activity to decrease the risk for inclusion of a woman with anearly undetected pregnancy.

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and inthe protocol.

Exclusion

Exclusion Criteria:

  • 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 oruncontrolled, 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, putthe participant at undue risk.

  • Participants who have developed any other medical diseases (eg, cardiopulmonary),laboratory abnormalities, or conditions (eg, poor venous access) that, in theopinion of the investigator could significantly alter the absorption, metabolism, orelimination of drugs; constitutes a risk when taking the study intervention;interferes with the interpretation of data; or it is not safe for the participant tocontinue on the study.

  • Participants who have been exposed to ionizing radiation in excess of 10millisievert (mSv) above background over the previous 3 year period as a result ofoccupational exposure or previous participation in research studies.

  • QT Interval Corrected (QTc) greater than (>) 480 millisecond (msec) at Week 52 ofparent study 218224 or study 221672.

Study Design

Total Participants: 514
Treatment Group(s): 1
Primary Treatment: Belimumab
Phase: 3
Study Start date:
December 12, 2024
Estimated Completion Date:
December 27, 2029

Connect with a study center

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1015ABO
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, 1425
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • GSK Investigational Site

    Sao Paulo, 01308-050
    Brazil

    Site Not Available

  • GSK Investigational Site

    Beijing, 100020
    China

    Active - Recruiting

  • GSK Investigational Site

    Beijing 1816670, 100020
    China

    Active - Recruiting

  • GSK Investigational Site

    Chengdu, 610072
    China

    Site Not Available

  • GSK Investigational Site

    Nanjing, 210029
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai, 200040
    China

    Site Not Available

  • GSK Investigational Site

    Zhuzhou 1783763, 412007
    China

    Active - Recruiting

  • GSK Investigational Site

    Athens, 11527
    Greece

    Site Not Available

  • GSK Investigational Site

    Larissa 258576, 41110
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Roma, 00161
    Italy

    Site Not Available

  • GSK Investigational Site

    Hokkaido, 060-8648
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Tokyo 1850147, 113-8603
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Yongsan-Ku Seoul,
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Yongsan-Ku Seoul,
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08025
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28007
    Spain

    Site Not Available

  • GSK Investigational Site

    London 2643743, NW3 2QG
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

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