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

Launched by GLAXOSMITHKLINE · May 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called belimumab to see how well it works and how safe it is for adults with a condition known as systemic sclerosis associated interstitial lung disease (SSc-ILD). SSc-ILD is a serious illness that affects the lungs and skin, causing thickening of the skin and breathing difficulties. The researchers will compare the effects of belimumab to a placebo (a harmless dummy treatment) in addition to the standard treatments that participants usually receive. They will look at how belimumab affects lung function and other symptoms, such as skin changes and fatigue, which can greatly impact a person's quality of life.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of systemic sclerosis with specific symptoms, including thickened skin and evidence of lung disease. Participants should be able to self-administer the treatment or have someone who can help them. Throughout the study, participants can expect regular check-ups to monitor their health and the effects of the medication. It’s important to note that certain other health conditions, recent treatments, or medications may exclude someone from participating, so potential volunteers should discuss their medical history with the study team.

Gender

ALL

Eligibility 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.