A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
NCT ID: NCT05878717
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2023-09-13
2029-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Belimumab
Participants will receive belimumab in addition to standard therapy.
Belimumab
Belimumab will be administered.
Placebo
Participants will receive placebo in addition to standard therapy.
Placebo
.Placebo will be administered.
Interventions
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Belimumab
Belimumab will be administered.
Placebo
.Placebo will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
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Los Angeles, California, United States
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Upland, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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Potsdam, New York, United States
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Cincinnati, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Denison, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Ciudad Autonoma Buenos Aires, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
GSK Investigational Site
Liverpool, New South Wales, Australia
GSK Investigational Site
Adelaide, South Australia, Australia
GSK Investigational Site
Woodville, South Australia, Australia
GSK Investigational Site
Fitzroy, Victoria, Australia
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Belo Horizonte, , Brazil
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Curitiba, , Brazil
GSK Investigational Site
Juiz de Fora, , Brazil
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Porto Alegre, , Brazil
GSK Investigational Site
Porto Alegre, , Brazil
GSK Investigational Site
Salvador, , Brazil
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São Paulo, , Brazil
GSK Investigational Site
São Paulo, , Brazil
GSK Investigational Site
Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
GSK Investigational Site
Changchun, , China
GSK Investigational Site
Chengdu, , China
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Chengdu, , China
GSK Investigational Site
Luzhou, , China
GSK Investigational Site
Mianyang, , China
GSK Investigational Site
Nanjing, , China
GSK Investigational Site
Nanjing, , China
GSK Investigational Site
Nanning, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Shenyang, , China
GSK Investigational Site
Xi'an, , China
GSK Investigational Site
Zhuzhou, , China
GSK Investigational Site
Aarhus, , Denmark
GSK Investigational Site
Odense C, , Denmark
GSK Investigational Site
Turku, , Finland
GSK Investigational Site
Bobigny, , France
GSK Investigational Site
Brest, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
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Paris, , France
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Toulouse, , France
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Cologne, , Germany
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Düsseldorf, , Germany
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Mainz, , Germany
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Minden, , Germany
GSK Investigational Site
Tübingen, , Germany
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Athens, , Greece
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Heraklion Crete, , Greece
GSK Investigational Site
Larissa, , Greece
GSK Investigational Site
Thessaloniki, , Greece
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Haifa, , Israel
GSK Investigational Site
Holon, , Israel
GSK Investigational Site
Kfar Saba, , Israel
GSK Investigational Site
Poria – Neve Oved, , Israel
GSK Investigational Site
Ramat Gan, , Israel
GSK Investigational Site
Tel Aviv, , Israel
GSK Investigational Site
Ancona, , Italy
GSK Investigational Site
Bari, , Italy
GSK Investigational Site
Cagliari, , Italy
GSK Investigational Site
Catania, , Italy
GSK Investigational Site
Ferrara, , Italy
GSK Investigational Site
Florence, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Orbassano to, , Italy
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Padua, , Italy
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Pavia, , Italy
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Roma, , Italy
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Verona, , Italy
GSK Investigational Site
Gunma, , Japan
GSK Investigational Site
Hiroshima, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Hokkaido, , Japan
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Kanagawa, , Japan
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Miyagi, , Japan
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Shizuoka, , Japan
GSK Investigational Site
Tokushima, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Chihuahua City, , Mexico
GSK Investigational Site
Guadalajara, , Mexico
GSK Investigational Site
Mérida, , Mexico
GSK Investigational Site
Torreón, , Mexico
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Suwon Kyunggi-do, , South Korea
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Bilbao, , Spain
GSK Investigational Site
Granada, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
VigoPontevedra, , Spain
GSK Investigational Site
Birmingham, , United Kingdom
GSK Investigational Site
Leeds, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Portsmouth, , United Kingdom
GSK Investigational Site
Wakefield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-503219-14-01
Identifier Type: REGISTRY
Identifier Source: secondary_id
218224
Identifier Type: -
Identifier Source: org_study_id
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