A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Last updated: February 4, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

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 clinical study 218224 (Parent Study). 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 that have completed Study 218224 through to and includingthe Week 52 visit and are not considered treatment failure, defined as meetingeither of the following criteria:
  1. Initiation of new immunosuppressive or immunomodulatory medication forSSc-related disease activity/progression since joining study 218224.

  2. Discontinuation of study medication during study 218224 for any reason.

  • Participant has an area of uninvolved or mildly thickened skin that, in the opinionof the investigator, would allow subcutaneous (SC) injection at the abdomen or thefront, 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), 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 who have discontinued study treatment, prior to Week
  • Participants who have developed clinical evidence of significant, unstable oruncontrolled, acute or chronic diseases not due to SSc (i.e, cardiovascular,pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancyor infectious diseases), or experienced an AE in Study 218224 that could, in theopinion of the principal investigator, put the 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 (Day 1 of 219855).

Study Design

Total Participants: 225
Treatment Group(s): 1
Primary Treatment: Belimumab
Phase: 3
Study Start date:
December 12, 2024
Estimated Completion Date:
January 08, 2030

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

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires,
    Argentina

    Site Not Available

  • GSK Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • GSK Investigational Site

    LiEge, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Belo Horizonte, 30150221
    Brazil

    Site Not Available

  • GSK Investigational Site

    Curitiba, 80440-080
    Brazil

    Site Not Available

  • GSK Investigational Site

    Juiz de Fora, 36010-570
    Brazil

    Site Not Available

  • GSK Investigational Site

    Porto Alegre,
    Brazil

    Site Not Available

  • GSK Investigational Site

    SAo Paulo, 04038-002
    Brazil

    Site Not Available

  • GSK Investigational Site

    Salvador, 40.150-150
    Brazil

    Site Not Available

  • GSK Investigational Site

    Sao Paulo, 01308-050
    Brazil

    Site Not Available

  • GSK Investigational Site

    Beijing, 100730
    China

    Site Not Available

  • GSK Investigational Site

    Changchun, 130021
    China

    Site Not Available

  • GSK Investigational Site

    Chengdu, 610041
    China

    Site Not Available

  • GSK Investigational Site

    Luzhou, 648000
    China

    Site Not Available

  • GSK Investigational Site

    Mianyang,
    China

    Site Not Available

  • GSK Investigational Site

    Nanjing, 210008
    China

    Site Not Available

  • GSK Investigational Site

    Nanning, 530000
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai, 200001
    China

    Site Not Available

  • GSK Investigational Site

    Shenyang, 110001
    China

    Site Not Available

  • GSK Investigational Site

    ZhuZhou, 412007
    China

    Site Not Available

  • GSK Investigational Site

    Aarhus, 8200
    Denmark

    Site Not Available

  • GSK Investigational Site

    Odense C, 5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Turku, 20520
    Finland

    Site Not Available

  • GSK Investigational Site

    Bobigny cedex, 93000
    France

    Site Not Available

  • GSK Investigational Site

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • GSK Investigational Site

    Duesseldorf, 40225
    Germany

    Site Not Available

  • GSK Investigational Site

    Koeln, 51149
    Germany

    Site Not Available

  • GSK Investigational Site

    Mainz, 55131
    Germany

    Site Not Available

  • GSK Investigational Site

    Minden, 32429
    Germany

    Site Not Available

  • GSK Investigational Site

    Tuebingen, 72076
    Germany

    Site Not Available

  • GSK Investigational Site

    Athens, 12462
    Greece

    Site Not Available

  • GSK Investigational Site

    Heraklion Crete, 71110
    Greece

    Site Not Available

  • GSK Investigational Site

    Larissa, 41110
    Greece

    Site Not Available

  • GSK Investigational Site

    Thessaloniki, 546 42
    Greece

    Site Not Available

  • GSK Investigational Site

    Haifa, 3436212
    Israel

    Site Not Available

  • GSK Investigational Site

    Holon, 58100
    Israel

    Site Not Available

  • GSK Investigational Site

    Kfar Saba, 44281
    Israel

    Site Not Available

  • GSK Investigational Site

    Poriya, 15208
    Israel

    Site Not Available

  • GSK Investigational Site

    Tel Aviv, 64239
    Israel

    Site Not Available

  • GSK Investigational Site

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • GSK Investigational Site

    Ancona,
    Italy

    Site Not Available

  • GSK Investigational Site

    Bari,
    Italy

    Site Not Available

  • GSK Investigational Site

    Cagliari, 09042
    Italy

    Site Not Available

  • GSK Investigational Site

    Catania,
    Italy

    Site Not Available

  • GSK Investigational Site

    Ferrara,
    Italy

    Site Not Available

  • GSK Investigational Site

    Firenze, 50134
    Italy

    Site Not Available

  • GSK Investigational Site

    Milano,
    Italy

    Site Not Available

  • GSK Investigational Site

    Modena, 41124
    Italy

    Site Not Available

  • GSK Investigational Site

    Napoli, 80131
    Italy

    Site Not Available

  • GSK Investigational Site

    Orbassano TO,
    Italy

    Site Not Available

  • GSK Investigational Site

    Padova,
    Italy

    Site Not Available

  • GSK Investigational Site

    Pavia,
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma,
    Italy

    Site Not Available

  • GSK Investigational Site

    Verona, 37134
    Italy

    Site Not Available

  • GSK Investigational Site

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Suwon Kyunggi-do, 16499
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Yongsan-Ku Seoul,
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Chihuahua, 31000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Ciudad de Mexico, 03310
    Mexico

    Site Not Available

  • GSK Investigational Site

    Guadalajara, 44650
    Mexico

    Site Not Available

  • GSK Investigational Site

    Merida, CP 97070
    Mexico

    Site Not Available

  • GSK Investigational Site

    Torreon, 27000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08035
    Spain

    Site Not Available

  • GSK Investigational Site

    Bilbao, 48013
    Spain

    Site Not Available

  • GSK Investigational Site

    Granada, 18016
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28046
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46026
    Spain

    Site Not Available

  • GSK Investigational Site

    VigoPontevedra, 36200
    Spain

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.