A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified December 2025 by GlaxoSmithKline
Sponsor
GlaxoSmithKline
Information Provided by (Responsible Party)
GlaxoSmithKline
Clinicaltrials.gov Identifier
NCT05878717
Other Study ID Numbers:
218224
First Submitted
May 18, 2023
First Posted
May 25, 2023
Last Update Posted
January 11, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Systemic Sclerosis Associated Interstitial Lung DiseaseScleroderma, Systemic
Biological: BelimumabOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)
Study Start DateSeptember 12, 2023
Actual Primary Completion Date3yrs 1d from now
Actual Study Completion Date3yrs 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Belimumab
Participants will receive belimumab in addition to standard therapy.
Biological: Belimumab
Belimumab will be administered.
Placebo
Participants will receive placebo in addition to standard therapy.
Other: Placebo
.Placebo will be administered.

Outcome Measures

Primary Outcome Measures
  1. Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Secondary Outcome Measures
  1. Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
    The modified Rodnan Skin Score (mRSS) is an evaluation of the patients skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The assessment is made across 17 pre-defined areas of the body, with total score ranging between 0 and 51. Higher scores indicate worse skin thickening.
  2. Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
    FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including SSc. FACIT-Fatigue scores range from 0-52 (higher scores indicate less fatigue).
  3. Time to Systemic sclerosis (SSc) progression or death
    SSc progression or death is defined as the time when major organ-based complications develop, or the participant dies.
  4. Absolute change from baseline in FVC percentage (%) predicted at Week 52
  5. Relative decline from baseline in FVC (mL) greater than or equal to (≥)5% at Week 52
  6. Relative decline from baseline in FVC (mL) ≥10% at Week 52
  7. Absolute change from baseline in mRSS at Week 26
    The modified Rodnan Skin Score (mRSS) is an evaluation of the patients skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold. The assessment is made across 17 pre-defined areas of the body and therefore the total score can range from 0 to 51. Higher scores indicate worse skin thickening.
  8. Proportion of participants achieving ≥20% increase in mRSS at Week 26 & 52
  9. Absolute change from baseline in Quantitative interstitial lung disease - whole lung (QILD-WL) at Week 52
  10. Absolute change from baseline in Quantitative lung fibrosis - whole lung (QLF-WL) at Week 52
  11. Proportion of participants achieving ≥2% increase in QILD at Week 52
  12. Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52
  13. Relative decline from baseline in DLco % predicted ≥15% at Week 52
  14. Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
    The cough NRS enables the participant to rate their cough on a defined scale from 0 to 10, where higher score indicating worse cough symptoms.
  15. Absolute change from baseline in Scleroderma Skin Patient-Reported Outcome (SSPRO) at Week 52
    SSPRO a patient-reported outcome (PRO) instrument developed to assess the skin-related quality of life (QoL) in participants with SSc. SSPRO has 18 items that assess four SSc skin-related HRQoL domain (emotional effects, physical effects, physical limitations and social effects). The higher score indicates worse impact on QoL.
  16. Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
    The HAQ-DI is a 26-question instrument assessing the degree of difficulty in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each question is scored 0-3 (where 0=without difficulty \& 3=unable to do). Higher scores reflect worse disability
  17. Absolute change from baseline in Short Form-36 Health Survey Questionnaire (SF-36) at Week 52
    The SF-36 yields an 8-scale profile of functional health and well-being scores as well as physical and mental component health summary scores. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
  18. Absolute change from baseline in Patient Global Assessment of SSc Disease Activity (PtGA) at Week 52.
    PtGA is a patient reported outcome scale designed to capture the participants overall assessment of their disease. The participants are asked to score their disease on a scale from 0 to 10 where higher score indicates higher severity
  19. Absolute change from baseline in Physician global assessment (PhGA) at Week 52
    The PhGA is a score which enables the treating physician to rate the participants disease on a scale from 0 to 10, where higher score indicates greater severity.
  20. Absolute change from baseline in Transition Dyspnea Index (TDI) at Week 52
    TDI assess dyspnea severity over 3 components: functional impairment, magnitude of task and magnitude of effort. Each component has 7 grades, ranging from -3 (major deterioration) to +3 (major improvement), which are summed to calculate a score, ranging between -9 and +9. The lower the score the more severely the participant is affected by dyspnea.
  21. Number of participants with Adverse Events (AEs), Adverse Events of special interest (AESIs) and Serious AEs (SAEs) up to Week 52
  22. Absolute change from baseline in DLco % predicted at Week 52

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent. 2. Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria. 3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS \>0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1. 4. Total mRSS ≥15 on Day 1. 5. Evidence of interstitial lung disease on centrally read screening HRCT. 6. Anticentromere antibody negative on central test at screening. 7. Evidence for active or progressive disease 8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh. 9. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study. 10. A female participant is eligible to participate if she is not pregnant 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. 11. Capable of giving signed informed consent.
Exclusion Criteria
1. Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \[nephrogenic systemic fibrosis\], or due to metabolic disease). 2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator. 3. FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening. 4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1). 5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1). 6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. 7. Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC \<0.7). 8. Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD). 9. Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant). 10. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives (whichever is longer) prior to dosing. 11. Treatment with rituximab within 6 months prior to Day 1. 12. Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine (including, but not limited to cyclosporine A, tacrolimus, leflunomide, oral or parenteral gold, Janus kinase (JAK) inhibitors) within 3 months prior to Day 1. 13. Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1. 14. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) within 4 weeks prior to Day 1. 15. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1. 16. Treatment with IM or IV corticosteroids within 1 month prior to Day 1.

Contacts and Locations

Sponsors and CollaboratorsGlaxoSmithKline
Locations
GSK Investigational Site | Phoenix Arizona, United States, 85027GSK Investigational Site | Scottsdale Arizona, United States, 85258GSK Investigational Site | Scottsdale Arizona, United States, 85259GSK Investigational Site | Tucson Arizona, United States, 85724GSK Investigational Site | Los Angeles California, United States, 90095GSK Investigational Site | Los Angeles California, United States, 90095GSK Investigational Site | Los Angeles California, United States, 90301GSK Investigational Site | Upland California, United States, 91786GSK Investigational Site | Aurora Colorado, United States, 80033GSK Investigational Site | Washington D.C. District of Columbia, United States, 20007GSK Investigational Site | Jacksonville Florida, United States, 32610GSK Investigational Site | Miami Florida, United States, 33144GSK Investigational Site | Chicago Illinois, United States, 60611GSK Investigational Site | Baltimore Maryland, United States, 21224GSK Investigational Site | Ann Arbor Michigan, United States, 48109GSK Investigational Site | New Brunswick New Jersey, United States, 08901GSK Investigational Site | New York New York, United States, 10021GSK Investigational Site | New York New York, United States, 11201GSK Investigational Site | Potsdam New York, United States, 13676GSK Investigational Site | Cincinnati Ohio, United States, 45206GSK Investigational Site | Philadelphia Pennsylvania, United States, 19104GSK Investigational Site | Philadelphia Pennsylvania, United States, 19140GSK Investigational Site | Denison Texas, United States, 75020GSK Investigational Site | El Paso Texas, United States, 79902GSK Investigational Site | Houston Texas, United States, 77030GSK Investigational Site | Buenos Aires , Argentina, GSK Investigational Site | Ciudad Autonoma Buenos Aires , Argentina, C1015ABOGSK Investigational Site | Ciudad Autonoma de Buenos Aire , Argentina, GSK Investigational Site | Liverpool New South Wales, Australia, 2170GSK Investigational Site | Adelaide South Australia, Australia, 5000GSK Investigational Site | Woodville South Australia, Australia, 5011GSK Investigational Site | Fitzroy Victoria, Australia, 3065GSK Investigational Site | Ghent , Belgium, 9000GSK Investigational Site | Liège , Belgium, 4000GSK Investigational Site | Belo Horizonte , Brazil, 30150221GSK Investigational Site | Curitiba , Brazil, 80440-080GSK Investigational Site | Juiz de Fora , Brazil, 36010-570GSK Investigational Site | Porto Alegre , Brazil, 90020-090GSK Investigational Site | Porto Alegre , Brazil, GSK Investigational Site | Salvador , Brazil, 40.150-150GSK Investigational Site | São Paulo , Brazil, 01308-050GSK Investigational Site | São Paulo , Brazil, 04038-002GSK Investigational Site | Beijing , China, 100020GSK Investigational Site | Beijing , China, 100191GSK Investigational Site | Beijing , China, 100730GSK Investigational Site | Beijing , China, 100730GSK Investigational Site | Changchun , China, 130021GSK Investigational Site | Chengdu , China, 610041GSK Investigational Site | Chengdu , China, 610072GSK Investigational Site | Luzhou , China, 648000GSK Investigational Site | Mianyang , China, GSK Investigational Site | Nanjing , China, 210008GSK Investigational Site | Nanjing , China, 210029GSK Investigational Site | Nanning , China, 530000GSK Investigational Site | Shanghai , China, 200001GSK Investigational Site | Shanghai , China, 200040GSK Investigational Site | Shenyang , China, 110001GSK Investigational Site | Xi'an , China, 710061GSK Investigational Site | Zhuzhou , China, 412007GSK Investigational Site | Aarhus , Denmark, 8200GSK Investigational Site | Odense C , Denmark, 5000GSK Investigational Site | Turku , Finland, 20520GSK Investigational Site | Bobigny , France, 93000GSK Investigational Site | Brest , France, 29609GSK Investigational Site | Paris , France, 75014GSK Investigational Site | Paris , France, 75014GSK Investigational Site | Paris , France, 75651GSK Investigational Site | Toulouse , France, 31059GSK Investigational Site | Cologne , Germany, 51149GSK Investigational Site | Düsseldorf , Germany, 40225GSK Investigational Site | Mainz , Germany, 55131GSK Investigational Site | Minden , Germany, 32429GSK Investigational Site | Tübingen , Germany, 72076GSK Investigational Site | Athens , Greece, 11527GSK Investigational Site | Athens , Greece, 12462GSK Investigational Site | Heraklion Crete , Greece, 71110GSK Investigational Site | Larissa , Greece, 41110GSK Investigational Site | Thessaloniki , Greece, 546 36GSK Investigational Site | Haifa , Israel, 3436212GSK Investigational Site | Holon , Israel, 58100GSK Investigational Site | Kfar Saba , Israel, 44281GSK Investigational Site | Poria – Neve Oved , Israel, 15208GSK Investigational Site | Ramat Gan , Israel, 52621GSK Investigational Site | Tel Aviv , Israel, 6423906GSK Investigational Site | Ancona , Italy, 60126GSK Investigational Site | Bari , Italy, 70124GSK Investigational Site | Cagliari , Italy, 09042GSK Investigational Site | Catania , Italy, 95123GSK Investigational Site | Ferrara , Italy, 44124GSK Investigational Site | Florence , Italy, 50134GSK Investigational Site | Milan , Italy, 20122GSK Investigational Site | Modena , Italy, 41125GSK Investigational Site | Naples , Italy, 80131GSK Investigational Site | Orbassano to , Italy, 10043GSK Investigational Site | Padova , Italy, 35128GSK Investigational Site | Pavia , Italy, 27100GSK Investigational Site | Roma , Italy, 00161GSK Investigational Site | Roma , Italy, 00186GSK Investigational Site | Verona , Italy, 37134GSK Investigational Site | Gunma , Japan, 371-8511GSK Investigational Site | Hiroshima , Japan, 734-8551GSK Investigational Site | Hokkaido , Japan, 060-8543GSK Investigational Site | Hokkaido , Japan, 060-8648GSK Investigational Site | Kanagawa , Japan, 236-0051GSK Investigational Site | Miyagi , Japan, 980-8574GSK Investigational Site | Shizuoka , Japan, 431-3192GSK Investigational Site | Tokushima , Japan, 770-8503GSK Investigational Site | Tokyo , Japan, 113-8603GSK Investigational Site | Chihuahua City , Mexico, 31000GSK Investigational Site | Guadalajara , Mexico, 44650GSK Investigational Site | Mérida , Mexico, CP 97070GSK Investigational Site | Torreón , Mexico, 27000GSK Investigational Site | Seoul , South Korea, 04763GSK Investigational Site | Seoul , South Korea, 05505GSK Investigational Site | Seoul , South Korea, 06591GSK Investigational Site | Seoul , South Korea, 140 887GSK Investigational Site | Suwon Kyunggi-do , South Korea, 16499GSK Investigational Site | Barcelona , Spain, 08025GSK Investigational Site | Barcelona , Spain, 08035GSK Investigational Site | Bilbao , Spain, 48013GSK Investigational Site | Granada , Spain, 18016GSK Investigational Site | Madrid , Spain, 28007GSK Investigational Site | Madrid , Spain, 28046GSK Investigational Site | Seville , Spain, 41013GSK Investigational Site | Valencia , Spain, 46026GSK Investigational Site | VigoPontevedra , Spain, 36200GSK Investigational Site | Birmingham , United Kingdom, B15 2GWGSK Investigational Site | Leeds , United Kingdom, LS7 4SAGSK Investigational Site | London , United Kingdom, NW3 2QGGSK Investigational Site | Portsmouth , United Kingdom, SG1 4ABGSK Investigational Site | Wakefield , United Kingdom, WF1 4DG