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Looking for participantsPhase2/Phase3

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

Sponsor: GlaxoSmithKline

NCT ID: NCT05878717

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Belimumab (biological), Placebo (other)
How long the study runs
Study runs about 73 months (dates as stated)
About the drug or intervention
Belimumab — biological: Belimumab will be administered. · Placebo — other: .Placebo will be administered.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
300
Started
2023-09-13
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic sclerosis associated interstitial lung disease
  • • Phase2/Phase3 - 300 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with systemic sclerosis associated interstitial lung disease

Where?

  • • Wakefield - GSK Investigational Site
  • • Birmingham - GSK Investigational Site
  • • Leeds - GSK Investigational Site
  • • London - GSK Investigational Site
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Systemic Sclerosis Associated Interstitial Lung DiseaseScleroderma, Systemic

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

antibody negative

What the study is looking for

  • ✓Participant is 18 years of age inclusive, or older at the time of signing the agreement to take part.
  • ✓Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism...
  • ✓Diffuse cutaneous disease, defined as presence of thickened skin with mRSS \>0 over at least one skin area proximal...
  • ✓Total mRSS ≥15 on Day 1.
  • ✓Evidence of interstitial lung disease on centrally read screening HRCT.

Who cannot take part

  • ✗FVC ≤45% of predicted, or a DLco (corrected for red blood cell level) ≤40% of predicted or requiring supplemental oxygen at...
  • ✗lung arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
  • ✗SSc kidney crisis within 6 months prior to the first day of dosing (Day 1).
  • ✗Obstructive lung disease (pre-bronchodilator FEV1/FVC \<0.7).
  • ✗Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
See the full 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.

Where Is This Study? (5 UK sites)

GSK Investigational Site

Wakefield WF1 4DG, United Kingdom

Recruiting
Site contact (verified)
Muthu ThirumaranPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Birmingham B15 2GW, United Kingdom

Recruiting
Site contact (verified)
Emma Derrett-SmithPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Leeds LS7 4SA, United Kingdom

Recruiting
Site contact (verified)
Francesco DelgaldoPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Christopher DentonPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Portsmouth SG1 4AB, United Kingdom

COMPLETED

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09