A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

Last updated: January 15, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Musculoskeletal Diseases

Connective Tissue Diseases

Treatment

Placebo

Belimumab

Clinical Study ID

NCT06572384
221672
2024-513018-36
  • Ages > 18
  • All Genders

Study Summary

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis,dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixedconnective tissue disease (MCTD) in accordance with internationally recognizedclassification criteria

  • Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extentof greater than or equal to (≥) 10% of the whole lung (WLILD)

  • Evidence of ILD progression in the previous 24 months

  • Must be currently receiving stable standard therapy to manage ILD and/or underlyingCTD, or to have failed or failed to tolerate first line standard therapy.

  • Participant is capable and willing to self-administer the study medication or has acaregiver who is capable and willing to administer the study medication throughoutthe study

  • A female participant is eligible to participate if she is not pregnant orbreastfeeding, and one of the following conditions applies:

  • Is a woman of nonchildbearing potential (WONCBP) OR

  • Is a Woman of childbearing potential (WOCBP) and using a contraceptive methodthat is highly effective, with a failure rate of less than (<)1%

  • Capable of giving signed informed consent

Exclusion

Exclusion Criteria:

  • Diagnosis of ILD other than CTD-ILD.

  • Primary diagnosis of Systemic Sclerosis (SSc).

  • Participants with rapidly progressive disease (absolute drop of 10% or more of FVCbetween screening and baseline visit and/or recent pulmonary hospitalisation).

  • FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted or requiring supplementaloxygen at screening

  • History or presence of diffuse alveolar haemorrhage (DAH) or other confoundingpulmonary disease, signs, or symptoms

  • Pulmonary arterial hypertension requiring therapy, as determined by the investigatorat, or prior to first day of dosing (Day 1)

  • Dependence on continuous oxygen supplementation

  • History or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, hematologic, or neurological disorders capable ofsignificantly altering the absorption, metabolism, or elimination of drugs;constituting a risk when taking the study intervention or interfering with theinterpretation of data

  • Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC <0.7).

  • Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD)

  • Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onsetor deteriorating neurologic signs and symptoms

  • Have evidence of moderate to severe depression, defined as PHQ-9 score ≥10, orserious current suicide risk, or any history of suicidal behavior in the last 6months and/or any suicidal ideation in the last 2 months, or who in theinvestigator's judgment, poses a significant suicide risk

  • Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cellor squamous epithelial carcinomas of the skin that have been resected with noevidence of metastatic disease for 3 years

  • Breast cancer within the past 10 years

  • Major surgery (including joint surgery) within 3 months prior to screening orplanned during the duration of the study

  • An active infection, or a history of infections

Study Design

Total Participants: 440
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 11, 2024
Estimated Completion Date:
December 13, 2028

Connect with a study center

  • GSK Investigational Site

    Buenos Aires, 1023
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, C1128AAF
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Cordoba, X5000AAW
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario, S2002
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    San Miguel de TucumAn, T4000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Murdoch, Western Australia 6163
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Adelaide, 5000
    Australia

    Site Not Available

  • GSK Investigational Site

    Woodville, 5011
    Australia

    Site Not Available

  • GSK Investigational Site

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • GSK Investigational Site

    LiEge, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Namur, 5000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Barra Mansa, 27323240
    Brazil

    Site Not Available

  • GSK Investigational Site

    Juiz de Fora, 36010-570
    Brazil

    Site Not Available

  • GSK Investigational Site

    Porto Alegre, 90480000
    Brazil

    Site Not Available

  • GSK Investigational Site

    SAo Paulo, 04004-030
    Brazil

    Site Not Available

  • GSK Investigational Site

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Sao Paulo, 05403-900
    Brazil

    Site Not Available

  • GSK Investigational Site

    Montreal, H3T 1E2
    Canada

    Site Not Available

  • GSK Investigational Site

    Trois RiviEres, G9A 4P3
    Canada

    Site Not Available

  • GSK Investigational Site

    Beijing, 100730
    China

    Active - Recruiting

  • GSK Investigational Site

    Chengdu, 610072
    China

    Active - Recruiting

  • GSK Investigational Site

    Guangzhou, 510630
    China

    Active - Recruiting

  • GSK Investigational Site

    Hangzhou, 310052
    China

    Site Not Available

  • GSK Investigational Site

    Mianyang,
    China

    Active - Recruiting

  • GSK Investigational Site

    Nanjing, 210029
    China

    Site Not Available

  • GSK Investigational Site

    Nanning, 530000
    China

    Active - Recruiting

  • GSK Investigational Site

    Shanghai, 200040
    China

    Active - Recruiting

  • GSK Investigational Site

    Shenyang, 110001
    China

    Site Not Available

  • GSK Investigational Site

    Suzhou,
    China

    Active - Recruiting

  • GSK Investigational Site

    Tianjin, 300052
    China

    Site Not Available

  • GSK Investigational Site

    ZhuZhou, 412007
    China

    Active - Recruiting

  • GSK Investigational Site

    Angers Cedex 9, 49933
    France

    Site Not Available

  • GSK Investigational Site

    Le Kremlin-BicEtre, 94275
    France

    Site Not Available

  • GSK Investigational Site

    Lille, 59037
    France

    Site Not Available

  • GSK Investigational Site

    Pessac cedex, 33604
    France

    Site Not Available

  • GSK Investigational Site

    Rouen Cedex, 76000
    France

    Site Not Available

  • GSK Investigational Site

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • GSK Investigational Site

    Essen, 45293
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Mainz, 55131
    Germany

    Site Not Available

  • GSK Investigational Site

    Minden, 32429
    Germany

    Site Not Available

  • GSK Investigational Site

    Sendenhorst, 48324
    Germany

    Site Not Available

  • GSK Investigational Site

    Wuerzburg, 97080
    Germany

    Site Not Available

  • GSK Investigational Site

    Athens, 124 62
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Larissa, 41110
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Ancona,
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Milano, 20132
    Italy

    Site Not Available

  • GSK Investigational Site

    Modena, 41124
    Italy

    Site Not Available

  • GSK Investigational Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Padova,
    Italy

    Site Not Available

  • GSK Investigational Site

    Pavia, 27100
    Italy

    Site Not Available

  • GSK Investigational Site

    Pisa, 56126
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma,
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Udine, 33100
    Italy

    Site Not Available

  • GSK Investigational Site

    Verona, 37134
    Italy

    Site Not Available

  • GSK Investigational Site

    Aichi, 470-1192
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Hiroshima, 734-8551
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Hokkaido, 060-8648
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kanagawa, 216-8511
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Miyagi, 983-8512
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Miyazaki, 889-1692
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Saitama, 350-0495
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Tokyo, 113-8603
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Tottori, 683-8504
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Yamanashi, 409-3898
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Bucheon Kyunggi-Do, 420-717
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Suwon Kyunggi-do, 443-721
    Korea, Republic of

    Active - Recruiting

  • 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

    DF, 14080
    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

    Mexico, 14080
    Mexico

    Site Not Available

  • GSK Investigational Site

    Monterrey, 64460
    Mexico

    Site Not Available

  • GSK Investigational Site

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Ciudad de Panama, 7099
    Panama

    Site Not Available

  • GSK Investigational Site

    Panama, 7002
    Panama

    Site Not Available

  • GSK Investigational Site

    Panama City,
    Panama

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • GSK Investigational Site

    COrdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Granada, 18016
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28007
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Malaga, 29530
    Spain

    Site Not Available

  • GSK Investigational Site

    Pamplona, 31008
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Santander, 39011
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 92868
    United States

    Site Not Available

  • GSK Investigational Site

    San Francisco, California 94143
    United States

    Site Not Available

  • GSK Investigational Site

    Upland, California 91786
    United States

    Site Not Available

  • GSK Investigational Site

    Gainesville, Florida 32608
    United States

    Site Not Available

  • GSK Investigational Site

    Naples, Florida 34102
    United States

    Active - Recruiting

  • GSK Investigational Site

    Bay Saint Louis, Mississippi 63110
    United States

    Site Not Available

  • GSK Investigational Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10032
    United States

    Site Not Available

  • GSK Investigational Site

    Potsdam, New York 13676
    United States

    Active - Recruiting

  • GSK Investigational Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • GSK Investigational Site

    Temple, Texas 76508
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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