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

NCT05878717 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2182242023-503219-14-01
• Study Type: interventional
• Target: 300
• Locations: 18 countries
• Sites: 131

Brief 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).

Conditions

Systemic Sclerosis Associated Interstitial Lung Disease; Scleroderma, Systemic

Keywords

Monoclonal antibody; Autoimmune connective tissue disease; Skin; lung; systemic sclerosis; scleroderma; interstitial lung disease; belimumab

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52

  Baseline and Week 52

Secondary Outcomes (22)

• Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52

  Baseline and Week 52

• Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52

  Baseline and Week 52

• Time to Systemic sclerosis (SSc) progression or death

  From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks

• Absolute change from baseline in FVC percentage (%) predicted at Week 52

  Baseline and Week 52

• Relative decline from baseline in FVC (mL) greater than or equal to (≥)5% at Week 52

  Baseline and Week 52

Study Arms (2)

Belimumab

EXPERIMENTAL

Participants will receive belimumab in addition to standard therapy.

Biological: Belimumab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo in addition to standard therapy.

Other: Placebo

Interventions

Belimumab BIOLOGICAL

Belimumab will be administered.

Also known as: BENLYSTA™, GSK1550188, LymphoStat-B™, BENLYSTATM, GSK1550188, LymphoStat-B™

Belimumab

Placebo OTHER

.Placebo will be administered.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 Potential (WOCBP) and using a contraceptive method that is highly effective.
• Capable of giving signed informed consent.

You may not qualify if:

• 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).
• 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.
• 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 drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
• 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, Janus kinase (JAK) inhibitors) within 3 months prior to Day 1.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (131)

GSK Investigational Site

Phoenix, Arizona, 85027, United States

COMPLETED

GSK Investigational Site

Scottsdale, Arizona, 85258, United States

RECRUITING

GSK Investigational Site

Scottsdale, Arizona, 85259, United States

RECRUITING

GSK Investigational Site

Tucson, Arizona, 85724, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90095, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90095, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90301, United States

RECRUITING

GSK Investigational Site

Upland, California, 91786, United States

RECRUITING

GSK Investigational Site

Aurora, Colorado, 80033, United States

RECRUITING

GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

RECRUITING

GSK Investigational Site

Jacksonville, Florida, 32610, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33144, United States

RECRUITING

GSK Investigational Site

Chicago, Illinois, 60611, United States

RECRUITING

GSK Investigational Site

Baltimore, Maryland, 21224, United States

RECRUITING

GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

RECRUITING

GSK Investigational Site

New Brunswick, New Jersey, 08901, United States

RECRUITING

GSK Investigational Site

New York, New York, 10021, United States

RECRUITING

GSK Investigational Site

New York, New York, 11201, United States

RECRUITING

GSK Investigational Site

Potsdam, New York, 13676, United States

RECRUITING

GSK Investigational Site

Cincinnati, Ohio, 45206, United States

RECRUITING

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

GSK Investigational Site

Denison, Texas, 75020, United States

RECRUITING

GSK Investigational Site

El Paso, Texas, 79902, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77030, United States

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

RECRUITING

GSK Investigational Site

Liverpool, New South Wales, 2170, Australia

COMPLETED

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

RECRUITING

GSK Investigational Site

Woodville, South Australia, 5011, Australia

RECRUITING

GSK Investigational Site

Fitzroy, Victoria, 3065, Australia

RECRUITING

GSK Investigational Site

Ghent, 9000, Belgium

RECRUITING

GSK Investigational Site

Liège, 4000, Belgium

RECRUITING

GSK Investigational Site

Belo Horizonte, 30150221, Brazil

RECRUITING

GSK Investigational Site

Curitiba, 80440-080, Brazil

COMPLETED

GSK Investigational Site

Juiz de Fora, 36010-570, Brazil

RECRUITING

GSK Investigational Site

Porto Alegre, 90020-090, Brazil

RECRUITING

GSK Investigational Site

Porto Alegre, Brazil

RECRUITING

GSK Investigational Site

Salvador, 40.150-150, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 01308-050, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 04038-002, Brazil

RECRUITING

GSK Investigational Site

Beijing, 100020, China

RECRUITING

GSK Investigational Site

Beijing, 100191, China

RECRUITING

GSK Investigational Site

Beijing, 100730, China

RECRUITING

GSK Investigational Site

Beijing, 100730, China

RECRUITING

GSK Investigational Site

Changchun, 130021, China

RECRUITING

GSK Investigational Site

Chengdu, 610041, China

RECRUITING

GSK Investigational Site

Chengdu, 610072, China

RECRUITING

GSK Investigational Site

Luzhou, 648000, China

RECRUITING

GSK Investigational Site

Mianyang, China

RECRUITING

GSK Investigational Site

Nanjing, 210008, China

RECRUITING

GSK Investigational Site

Nanjing, 210029, China

RECRUITING

GSK Investigational Site

Nanning, 530000, China

RECRUITING

GSK Investigational Site

Shanghai, 200001, China

RECRUITING

GSK Investigational Site

Shanghai, 200040, China

RECRUITING

GSK Investigational Site

Shenyang, 110001, China

RECRUITING

GSK Investigational Site

Xi'an, 710061, China

RECRUITING

GSK Investigational Site

Zhuzhou, 412007, China

RECRUITING

GSK Investigational Site

Aarhus, 8200, Denmark

RECRUITING

GSK Investigational Site

Odense C, 5000, Denmark

WITHDRAWN

GSK Investigational Site

Turku, 20520, Finland

RECRUITING

GSK Investigational Site

Bobigny, 93000, France

RECRUITING

GSK Investigational Site

Brest, 29609, France

RECRUITING

GSK Investigational Site

Paris, 75014, France

RECRUITING

GSK Investigational Site

Paris, 75014, France

RECRUITING

GSK Investigational Site

Paris, 75651, France

RECRUITING

GSK Investigational Site

Toulouse, 31059, France

RECRUITING

GSK Investigational Site

Cologne, 51149, Germany

RECRUITING

GSK Investigational Site

Düsseldorf, 40225, Germany

RECRUITING

GSK Investigational Site

Mainz, 55131, Germany

RECRUITING

GSK Investigational Site

Minden, 32429, Germany

RECRUITING

GSK Investigational Site

Tübingen, 72076, Germany

RECRUITING

GSK Investigational Site

Athens, 11527, Greece

WITHDRAWN

GSK Investigational Site

Athens, 12462, Greece

RECRUITING

GSK Investigational Site

Heraklion Crete, 71110, Greece

RECRUITING

GSK Investigational Site

Larissa, 41110, Greece

RECRUITING

GSK Investigational Site

Thessaloniki, 546 36, Greece

RECRUITING

GSK Investigational Site

Haifa, 3436212, Israel

RECRUITING

GSK Investigational Site

Holon, 58100, Israel

WITHDRAWN

GSK Investigational Site

Kfar Saba, 44281, Israel

WITHDRAWN

GSK Investigational Site

Poria – Neve Oved, 15208, Israel

RECRUITING

GSK Investigational Site

Ramat Gan, 52621, Israel

RECRUITING

GSK Investigational Site

Tel Aviv, 6423906, Israel

RECRUITING

GSK Investigational Site

Ancona, 60126, Italy

RECRUITING

GSK Investigational Site

Bari, 70124, Italy

RECRUITING

GSK Investigational Site

Cagliari, 09042, Italy

RECRUITING

GSK Investigational Site

Catania, 95123, Italy

RECRUITING

GSK Investigational Site

Ferrara, 44124, Italy

RECRUITING

GSK Investigational Site

Florence, 50134, Italy

RECRUITING

GSK Investigational Site

Milan, 20122, Italy

RECRUITING

GSK Investigational Site

Modena, 41125, Italy

RECRUITING

GSK Investigational Site

Naples, 80131, Italy

RECRUITING

GSK Investigational Site

Orbassano to, 10043, Italy

RECRUITING

GSK Investigational Site

Padua, 35128, Italy

RECRUITING

GSK Investigational Site

Pavia, 27100, Italy

RECRUITING

GSK Investigational Site

Roma, 00161, Italy

RECRUITING

GSK Investigational Site

Roma, 00186, Italy

RECRUITING

GSK Investigational Site

Verona, 37134, Italy

RECRUITING

GSK Investigational Site

Gunma, 371-8511, Japan

RECRUITING

GSK Investigational Site

Hiroshima, 734-8551, Japan

RECRUITING

GSK Investigational Site

Hokkaido, 060-8543, Japan

RECRUITING

GSK Investigational Site

Hokkaido, 060-8648, Japan

RECRUITING

GSK Investigational Site

Kanagawa, 236-0051, Japan

WITHDRAWN

GSK Investigational Site

Miyagi, 980-8574, Japan

RECRUITING

GSK Investigational Site

Shizuoka, 431-3192, Japan

RECRUITING

GSK Investigational Site

Tokushima, 770-8503, Japan

RECRUITING

GSK Investigational Site

Tokyo, 113-8603, Japan

RECRUITING

GSK Investigational Site

Chihuahua City, 31000, Mexico

RECRUITING

GSK Investigational Site

Guadalajara, 44650, Mexico

RECRUITING

GSK Investigational Site

Mérida, CP 97070, Mexico

RECRUITING

GSK Investigational Site

Torreón, 27000, Mexico

RECRUITING

GSK Investigational Site

Seoul, 04763, South Korea

RECRUITING

GSK Investigational Site

Seoul, 05505, South Korea

RECRUITING

GSK Investigational Site

Seoul, 06591, South Korea

RECRUITING

GSK Investigational Site

Seoul, 140 887, South Korea

RECRUITING

GSK Investigational Site

Suwon Kyunggi-do, 16499, South Korea

RECRUITING

GSK Investigational Site

Barcelona, 08025, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08035, Spain

RECRUITING

GSK Investigational Site

Bilbao, 48013, Spain

RECRUITING

GSK Investigational Site

Granada, 18016, Spain

RECRUITING

GSK Investigational Site

Madrid, 28007, Spain

RECRUITING

GSK Investigational Site

Madrid, 28046, Spain

RECRUITING

GSK Investigational Site

Seville, 41013, Spain

RECRUITING

GSK Investigational Site

Valencia, 46026, Spain

RECRUITING

GSK Investigational Site

VigoPontevedra, 36200, Spain

RECRUITING

GSK Investigational Site

Birmingham, B15 2GW, United Kingdom

RECRUITING

GSK Investigational Site

Leeds, LS7 4SA, United Kingdom

RECRUITING

GSK Investigational Site

London, NW3 2QG, United Kingdom

RECRUITING

GSK Investigational Site

Portsmouth, SG1 4AB, United Kingdom

RECRUITING

GSK Investigational Site

Wakefield, WF1 4DG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Lung Diseases, Interstitial

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where participant and investigator are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 26, 2023
• Study Start: September 13, 2023
• Primary Completion (Estimated): May 17, 2029
• Study Completion (Estimated): July 12, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

ES (9); FI (1); FR (6); GB (5); AU (4); CN (17); AR (3); DE (5); IT (15); JP (9); BR (8); DK (2); US (25); ME (4); KR (5); BE (2); GR (5); IL (6)