Last updated: 01/09/2026 07:20:22
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung DiseaseBLISSc-ILD
GSK study ID
218224
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: A 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)
Trial description: This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Timeframe: Baseline and Week 52
Secondary outcomes:
Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
Timeframe: Baseline and Week 52
Time to Systemic sclerosis (SSc) progression or death
Timeframe: From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
Absolute change from baseline in FVC percentage (%) predicted at Week 52
Timeframe: Baseline and Week 52
Relative decline from baseline in FVC (mL) greater than or equal to (≥)5% at Week 52
Timeframe: Baseline and Week 52
Relative decline from baseline in FVC (mL) ≥10% at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in mRSS at Week 26
Timeframe: Baseline and Week 26
Proportion of participants achieving ≥20% increase in mRSS at Week 26 & 52
Timeframe: At Week 26 and Week 52
Absolute change from baseline in Quantitative interstitial lung disease whole lung (QILDWL) at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Quantitative lung fibrosis whole lung (QLFWL) at Week 52
Timeframe: Baseline and Week 52
Proportion of participants achieving ≥2% increase in QILD at Week 52
Timeframe: At Week 52
Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52
Timeframe: Baseline and Week 52
Relative decline from baseline in DLco % predicted ≥15% at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Scleroderma Skin Patient-Reported Outcome (SSPRO) at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Short Form-36 Health Survey Questionnaire (SF-36) at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Patient Global Assessment of SSc Disease Activity (PtGA) at Week 52.
Timeframe: Baseline and Week 52
Absolute change from baseline in Physician global assessment (PhGA) at Week 52
Timeframe: Baseline and Week 52
Absolute change from baseline in Transition Dyspnea Index (TDI) at Week 52
Timeframe: Baseline and Week 52
Number of participants with Adverse Events (AEs), Adverse Events of special interest (AESIs) and Serious AEs (SAEs) up to Week 52
Timeframe: Up to Week 52
Absolute change from baseline in DLco % predicted at Week 52
Timeframe: Baseline and Week 52
Interventions:
Biological/vaccine: Belimumab
Other: Placebo
Enrollment:
300
Observational study model:
Not applicable
Primary completion date:
2029-17-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic sclerosis associated interstitial lung disease
Product
belimumab
Collaborators
Not applicable
Study date(s)
September 2023 to July 2029
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Status
Recruiting
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina
Status
Recruiting
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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