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Tests treatment safety and results for Systemic Sclerosis Associated Interstitial Lung Disease
Official title A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
ClinicalTrials.gov ID: NCT05878717
What this study is testing
What is Belimumab?
Belimumab is an investigational medicine, being studied as a potential treatment for systemic sclerosis associated interstitial lung disease.
Also referred to as BENLYSTA™, GSK1550188, LymphoStat-B™, BENLYSTATM, GSK1550188, LymphoStat-B™.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
- Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.
- 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...
- Total mRSS ≥15 on Day 1.
- Evidence of interstitial lung disease on centrally read screening HRCT.
You likely can't join if
- Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid...
- Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus...
- FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.
- Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
- SSc renal crisis within 6 months prior to the first day of dosing (Day 1).
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of...
See the full eligibility criteria
- Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
- Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.
- 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.
- Total mRSS ≥15 on Day 1.
- Evidence of interstitial lung disease on centrally read screening HRCT.
- Anticentromere antibody negative on central test at screening.
- Evidence for active or progressive disease
- 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.
- 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.
- 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...
- Capable of giving signed informed consent.
- Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema)...
- 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...
- FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.
- Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
- SSc renal crisis within 6 months prior to the first day of dosing (Day 1).
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of...
- Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC \<0.7).
- Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
- Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant).
- 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.
- Treatment with rituximab within 6 months prior to Day 1.
- 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...
- Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.
- 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.
- Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1.
- Treatment with IM or IV corticosteroids within 1 month prior to Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Upland, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Potsdam, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Denison, Texas, United States
- El Paso, Texas, United States
- Houston, Texas, United States
+ 88 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Upland, California, United States; Aurora, Colorado, United States and 102 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.