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A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Study Purpose
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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
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 Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05878717 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
GlaxoSmithKline |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic |
Arms
Experimental: Belimumab
Participants will receive belimumab in addition to standard therapy.
Placebo Comparator: Placebo
Participants will receive placebo in addition to standard therapy.
Interventions
Biological: - Belimumab
Belimumab will be administered.
Other: - Placebo
.Placebo will be administered.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
GSK Investigational Site
Phoenix, Arizona, 85027
Status
Recruiting
Address
GSK Investigational Site
Scottsdale, Arizona, 85258
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Recruiting
Address
GSK Investigational Site
Scottsdale, Arizona, 85259
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Recruiting
Address
GSK Investigational Site
Tucson, Arizona, 85724
Status
Recruiting
Address
GSK Investigational Site
Los Angeles, California, 90045
Status
Recruiting
Address
GSK Investigational Site
Los Angeles, California, 90095
Status
Recruiting
Address
GSK Investigational Site
Los Angeles, California, 90095
Status
Recruiting
Address
GSK Investigational Site
Upland, California, 91786
Status
Recruiting
Address
GSK Investigational Site
Aurora, Colorado, 80033
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Recruiting
Address
GSK Investigational Site
Washington, District of Columbia, 20007
Status
Recruiting
Address
GSK Investigational Site
Gainesville, Florida, 32610
Status
Recruiting
Address
GSK Investigational Site
Chicago, Illinois, 60611
Status
Recruiting
Address
GSK Investigational Site
Baltimore, Maryland, 21224
Status
Recruiting
Address
GSK Investigational Site
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
GSK Investigational Site
New Brunswick, New Jersey, 08901
Status
Recruiting
Address
GSK Investigational Site
Brooklyn, New York, 11201
Status
Recruiting
Address
GSK Investigational Site
New York, New York, 10021
Status
Recruiting
Address
GSK Investigational Site
Potsdam, New York, 13676
Status
Recruiting
Address
GSK Investigational Site
Cincinnati, Ohio, 45206
Status
Recruiting
Address
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
GSK Investigational Site
Dallas, Texas, 75390
Status
Recruiting
Address
GSK Investigational Site
El Paso, Texas, 79902
Status
Recruiting
Address
GSK Investigational Site
Houston, Texas, 77030
International Sites
Status
Recruiting
Address
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires,
Status
Recruiting
Address
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires,
Status
Recruiting
Address
GSK Investigational Site
Ciudad Autonoma Buenos Aires, , C1015ABO
Status
Recruiting
Address
GSK Investigational Site
Liverpool, New South Wales, 2170
Status
Recruiting
Address
GSK Investigational Site
Adelaide, South Australia, 5000
Status
Recruiting
Address
GSK Investigational Site
Woodville, South Australia, 5011
Status
Recruiting
Address
GSK Investigational Site
Fitzroy, Victoria, 3065
Status
Recruiting
Address
GSK Investigational Site
Gent, , 9000
Status
Recruiting
Address
GSK Investigational Site
Leuven, , 3000
Status
Recruiting
Address
GSK Investigational Site
Salvador, Bahía, 40.150-150
Status
Recruiting
Address
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30150221
Status
Recruiting
Address
GSK Investigational Site
Juiz de Fora, Minas Gerais, 36010-570
Status
Recruiting
Address
GSK Investigational Site
Curitba, Paraná, 80440-080
Status
Recruiting
Address
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, 90020-090
Status
Recruiting
Address
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul,
Status
Recruiting
Address
GSK Investigational Site
Sao Paulo, São Paulo, 01308-050
Status
Recruiting
Address
GSK Investigational Site
São Paulo, , 04038-002
Status
Recruiting
Address
GSK Investigational Site
Toronto, Ontario, M5T 3L9
Status
Recruiting
Address
GSK Investigational Site
Nanning, Guangxi, 530000
Status
Recruiting
Address
GSK Investigational Site
Nanning, Guangxi,
Status
Recruiting
Address
GSK Investigational Site
ZhuZhou, Hunan, 412007
Status
Recruiting
Address
GSK Investigational Site
Nanjing, Jiangsu, 210029
Status
Recruiting
Address
GSK Investigational Site
Changchun, Jilin, 130021
Status
Recruiting
Address
GSK Investigational Site
Chengdu, Sichuan, 610041
Status
Recruiting
Address
GSK Investigational Site
Chengdu, Sichuan, 610072
Status
Recruiting
Address
GSK Investigational Site
Beijing, , 100020
Status
Recruiting
Address
GSK Investigational Site
Beijing, , 100029
Status
Recruiting
Address
GSK Investigational Site
Beijing, , 100191
Status
Recruiting
Address
GSK Investigational Site
Beijing, , 100730
Status
Recruiting
Address
GSK Investigational Site
Beijing, , 100730
Status
Recruiting
Address
GSK Investigational Site
Luzhou, , 648000
Status
Recruiting
Address
GSK Investigational Site
Mianyang, ,
Status
Recruiting
Address
GSK Investigational Site
Nanjing, , 210008
Status
Recruiting
Address
GSK Investigational Site
Shanghai, , 200001
Status
Recruiting
Address
GSK Investigational Site
Shanghai, , 200040
Status
Recruiting
Address
GSK Investigational Site
Shenyang, , 110001
Status
Recruiting
Address
GSK Investigational Site
Xian, , 710061
Status
Recruiting
Address
GSK Investigational Site
Aarhus, , 8200
Status
Recruiting
Address
GSK Investigational Site
Køge, , 4600
Status
Recruiting
Address
GSK Investigational Site
Odense C, , 5000
Status
Recruiting
Address
GSK Investigational Site
Turku, , 20520
Status
Recruiting
Address
GSK Investigational Site
Bobigny, , 93000
Status
Recruiting
Address
GSK Investigational Site
Paris Cedex 13, , 75651
Status
Recruiting
Address
GSK Investigational Site
Paris, , 75014
Status
Recruiting
Address
GSK Investigational Site
Strasbourg, , 67000
Status
Recruiting
Address
GSK Investigational Site
Toulouse cedex 9, , 31059
Status
Recruiting
Address
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, 72076
Status
Recruiting
Address
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, 40225
Status
Recruiting
Address
GSK Investigational Site
Minden, Nordrhein-Westfalen, 32429
Status
Recruiting
Address
GSK Investigational Site
Wuppertal, Nordrhein-Westfalen, 42105
Status
Recruiting
Address
GSK Investigational Site
Bad Abbach, , 93077
Status
Recruiting
Address
GSK Investigational Site
Athens, Attiki, 11527
Status
Recruiting
Address
GSK Investigational Site
Athens, , 12462
Status
Recruiting
Address
GSK Investigational Site
Heraklion-Crete, , 71110
Status
Recruiting
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GSK Investigational Site
Larissa, , 41110
Status
Recruiting
Address
GSK Investigational Site
Thessaloniki, , 546 36
Status
Recruiting
Address
GSK Investigational Site
Haifa, , 3436212
Status
Recruiting
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GSK Investigational Site
Kfar Saba, , 44281
Status
Recruiting
Address
GSK Investigational Site
Tel Aviv, , 6423906
Status
Recruiting
Address
GSK Investigational Site
Tel Hashomer, , 52621
Status
Recruiting
Address
GSK Investigational Site
Tiberias, , 15208
Status
Recruiting
Address
GSK Investigational Site
Cona (Ferrara), Emilia-Romagna, 44124
Status
Recruiting
Address
GSK Investigational Site
Modena, Emilia-Romagna, 41125
Status
Recruiting
Address
GSK Investigational Site
Roma, Lazio, 00161
Status
Recruiting
Address
GSK Investigational Site
Roma, Lazio, 00186
Status
Recruiting
Address
GSK Investigational Site
Milano, Lombardia, 20122
Status
Recruiting
Address
GSK Investigational Site
Pavia, Lombardia, 27100
Status
Recruiting
Address
GSK Investigational Site
Torrette, Marche, 60126
Status
Recruiting
Address
GSK Investigational Site
Orbassano, Piemonte, 10043
Status
Recruiting
Address
GSK Investigational Site
Bari, Puglia, 70124
Status
Recruiting
Address
GSK Investigational Site
Monserrato, Sardegna, 09042
Status
Recruiting
Address
GSK Investigational Site
Catania, Sicilia, 95123
Status
Recruiting
Address
GSK Investigational Site
Padova, Veneto, 35128
Status
Recruiting
Address
GSK Investigational Site
Firenze, , 50134
Status
Recruiting
Address
GSK Investigational Site
Napoli, , 80131
Status
Recruiting
Address
GSK Investigational Site
Verona, , 37134
Status
Recruiting
Address
GSK Investigational Site
Gunma, , 371-8511
Status
Recruiting
Address
GSK Investigational Site
Hokkaido, , 060-8543
Status
Recruiting
Address
GSK Investigational Site
Hokkaido, , 060-8648
Status
Recruiting
Address
GSK Investigational Site
Kanagawa, , 236-0051
Status
Recruiting
Address
GSK Investigational Site
Miyagi, , 980-8574
Status
Recruiting
Address
GSK Investigational Site
Tokyo, , 113-8603
Status
Recruiting
Address
GSK Investigational Site
Seoul, , 04763
Status
Recruiting
Address
GSK Investigational Site
Seoul, , 05505
Status
Recruiting
Address
GSK Investigational Site
Seoul, , 06591
Status
Recruiting
Address
GSK Investigational Site
Seoul, , 140 887
Status
Recruiting
Address
GSK Investigational Site
Suwon-si, Gyeonggi-do, , 16499
Status
Recruiting
Address
GSK Investigational Site
Mexico City, Ciudad De Mexico, 14080
Status
Recruiting
Address
GSK Investigational Site
Torreon, Coahuila, 27000
Status
Recruiting
Address
GSK Investigational Site
Guadalajara, Jalisco, 44650
Status
Recruiting
Address
GSK Investigational Site
Merida, Yucatán, CP 97070
Status
Recruiting
Address
GSK Investigational Site
Chihuahua, , 31000
Status
Recruiting
Address
GSK Investigational Site
Barcelona, , 08036
Status
Recruiting
Address
GSK Investigational Site
Barcelona, , ?08035
Status
Recruiting
Address
GSK Investigational Site
Bilbao, , 48013
Status
Recruiting
Address
GSK Investigational Site
Granada, , 18016
Status
Recruiting
Address
GSK Investigational Site
Madrid, , 28007
Status
Recruiting
Address
GSK Investigational Site
Madrid, , 28046
Status
Recruiting
Address
GSK Investigational Site
Sevilla, , 41013
Status
Recruiting
Address
GSK Investigational Site
Valencia, , 46026
Status
Recruiting
Address
GSK Investigational Site
Vigo/ Pontevedra, , 36200
Status
Recruiting
Address
GSK Investigational Site
Edgbaston, , B15 2GW
Status
Recruiting
Address
GSK Investigational Site
Leeds, , LS7 4SA
Status
Recruiting
Address
GSK Investigational Site
London, , NW3 2QG