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NCT05878717PHASE2, PHASE3Recruiting

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

GlaxoSmithKline

Start Date

9/13/2023

Completion Date

7/12/2029

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

Belimumab

OTHER

Placebo

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Conditions

Systemic Sclerosis Associated Interstitial Lung DiseaseScleroderma, Systemic

Locations

GSK Investigational Site

Phoenix, Arizona 85027

United States

GSK Investigational Site

Scottsdale, Arizona 85258

United States

GSK Investigational Site

Scottsdale, Arizona 85259

United States

GSK Investigational Site

Tucson, Arizona 85724

United States

GSK Investigational Site

Los Angeles, California 90095

United States

GSK Investigational Site

Los Angeles, California 90095

United States

GSK Investigational Site

Los Angeles, California 90301

United States

GSK Investigational Site

Upland, California 91786

United States

GSK Investigational Site

Aurora, Colorado 80033

United States

GSK Investigational Site

Washington D.C., District of Columbia 20007

United States

GSK Investigational Site

Jacksonville, Florida 32610

United States

GSK Investigational Site

Miami, Florida 33144

United States

GSK Investigational Site

Chicago, Illinois 60611

United States

GSK Investigational Site

Baltimore, Maryland 21224

United States

GSK Investigational Site

Ann Arbor, Michigan 48109

United States

GSK Investigational Site

New Brunswick, New Jersey 08901

United States

GSK Investigational Site

New York, New York 10021

United States

GSK Investigational Site

New York, New York 11201

United States

GSK Investigational Site

Potsdam, New York 13676

United States

GSK Investigational Site

Cincinnati, Ohio 45206

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19104

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19140

United States

GSK Investigational Site

Denison, Texas 75020

United States

GSK Investigational Site

El Paso, Texas 79902

United States

GSK Investigational Site

Houston, Texas 77030

United States

GSK Investigational Site

Buenos Aires,

Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire,

Argentina

GSK Investigational Site

Liverpool, New South Wales 2170

Australia

GSK Investigational Site

Adelaide, South Australia 5000

Australia

GSK Investigational Site

Woodville, South Australia 5011

Australia

GSK Investigational Site

Fitzroy, Victoria 3065

Australia

GSK Investigational Site

Ghent, 9000

Belgium

GSK Investigational Site

Liège, 4000

Belgium

GSK Investigational Site

Belo Horizonte, 30150221

Brazil

GSK Investigational Site

Curitiba, 80440-080

Brazil

GSK Investigational Site

Juiz de Fora, 36010-570

Brazil

GSK Investigational Site

Porto Alegre, 90020-090

Brazil

GSK Investigational Site

Porto Alegre,

Brazil

GSK Investigational Site

Salvador, 40.150-150

Brazil

GSK Investigational Site

São Paulo, 01308-050

Brazil

GSK Investigational Site

São Paulo, 04038-002

Brazil

GSK Investigational Site

Beijing, 100020

China

GSK Investigational Site

Beijing, 100191

China

GSK Investigational Site

Beijing, 100730

China

GSK Investigational Site

Beijing, 100730

China

GSK Investigational Site

Changchun, 130021

China

GSK Investigational Site

Chengdu, 610041

China

GSK Investigational Site

Chengdu, 610072

China

GSK Investigational Site

Luzhou, 648000

China

GSK Investigational Site

Mianyang,

China

GSK Investigational Site

Nanjing, 210008

China

GSK Investigational Site

Nanjing, 210029

China

GSK Investigational Site

Nanning, 530000

China

GSK Investigational Site

Shanghai, 200001

China

GSK Investigational Site

Shanghai, 200040

China

GSK Investigational Site

Shenyang, 110001

China

GSK Investigational Site

Xi'an, 710061

China

GSK Investigational Site

Zhuzhou, 412007

China

GSK Investigational Site

Aarhus, 8200

Denmark

GSK Investigational Site

Odense C, 5000

Denmark

GSK Investigational Site

Turku, 20520

Finland

GSK Investigational Site

Bobigny, 93000

France

GSK Investigational Site

Brest, 29609

France

GSK Investigational Site

Paris, 75014

France

GSK Investigational Site

Paris, 75014

France

GSK Investigational Site

Paris, 75651

France

GSK Investigational Site

Toulouse, 31059

France

GSK Investigational Site

Cologne, 51149

Germany

GSK Investigational Site

Düsseldorf, 40225

Germany

GSK Investigational Site

Mainz, 55131

Germany

GSK Investigational Site

Minden, 32429

Germany

GSK Investigational Site

Tübingen, 72076

Germany

GSK Investigational Site

Athens, 11527

Greece

GSK Investigational Site

Athens, 12462

Greece

GSK Investigational Site

Heraklion Crete, 71110

Greece

GSK Investigational Site

Larissa, 41110

Greece

GSK Investigational Site

Thessaloniki, 546 36

Greece

GSK Investigational Site

Haifa, 3436212

Israel

GSK Investigational Site

Holon, 58100

Israel

GSK Investigational Site

Kfar Saba, 44281

Israel

GSK Investigational Site

Poria – Neve Oved, 15208

Israel

GSK Investigational Site

Ramat Gan, 52621

Israel

GSK Investigational Site

Tel Aviv, 6423906

Israel

GSK Investigational Site

Ancona, 60126

Italy

GSK Investigational Site

Bari, 70124

Italy

GSK Investigational Site

Cagliari, 09042

Italy

GSK Investigational Site

Catania, 95123

Italy

GSK Investigational Site

Ferrara, 44124

Italy

GSK Investigational Site

Florence, 50134

Italy

GSK Investigational Site

Milan, 20122

Italy

GSK Investigational Site

Modena, 41125

Italy

GSK Investigational Site

Naples, 80131

Italy

GSK Investigational Site

Orbassano to, 10043

Italy

GSK Investigational Site

Padova, 35128

Italy

GSK Investigational Site

Pavia, 27100

Italy

GSK Investigational Site

Roma, 00161

Italy

GSK Investigational Site

Roma, 00186

Italy

GSK Investigational Site

Verona, 37134

Italy

GSK Investigational Site

Gunma, 371-8511

Japan

GSK Investigational Site

Hiroshima, 734-8551

Japan

GSK Investigational Site

Hokkaido, 060-8543

Japan

GSK Investigational Site

Hokkaido, 060-8648

Japan

GSK Investigational Site

Kanagawa, 236-0051

Japan

GSK Investigational Site

Miyagi, 980-8574

Japan

GSK Investigational Site

Shizuoka, 431-3192

Japan

GSK Investigational Site

Tokushima, 770-8503

Japan

GSK Investigational Site

Tokyo, 113-8603

Japan

GSK Investigational Site

Chihuahua City, 31000

Mexico

GSK Investigational Site

Guadalajara, 44650

Mexico

GSK Investigational Site

Mérida, CP 97070

Mexico

GSK Investigational Site

Torreón, 27000

Mexico

GSK Investigational Site

Seoul, 04763

South Korea

GSK Investigational Site

Seoul, 05505

South Korea

GSK Investigational Site

Seoul, 06591

South Korea

GSK Investigational Site

Seoul, 140 887

South Korea

GSK Investigational Site

Suwon Kyunggi-do, 16499

South Korea

GSK Investigational Site

Barcelona, 08025

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Bilbao, 48013

Spain

GSK Investigational Site

Granada, 18016

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Seville, 41013

Spain

GSK Investigational Site

Valencia, 46026

Spain

GSK Investigational Site

VigoPontevedra, 36200

Spain

GSK Investigational Site

Birmingham, B15 2GW

United Kingdom

GSK Investigational Site

Leeds, LS7 4SA

United Kingdom

GSK Investigational Site

London, NW3 2QG

United Kingdom

GSK Investigational Site

Portsmouth, SG1 4AB

United Kingdom

GSK Investigational Site

Wakefield, WF1 4DG

United Kingdom