RecruitingPhase 2Phase 3NCT05878717

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

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)


Sponsor

GlaxoSmithKline

Enrollment

300 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Belimumab and Placebo for people with scleroderma, systemic and systemic sclerosis associated interstitial lung disease. The study is currently recruiting participants at 131 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBelimumab

Belimumab will be administered.

OTHERPlacebo

.Placebo will be administered.


Locations(131)

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

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Upland, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

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

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Ann Arbor, Michigan, United States

GSK Investigational Site

New Brunswick, New Jersey, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Potsdam, New York, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Denison, Texas, United States

GSK Investigational Site

El Paso, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Argentina

GSK Investigational Site

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

GSK Investigational Site

Curitiba, Brazil

GSK Investigational Site

Juiz de Fora, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Salvador, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Changchun, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

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

GSK Investigational Site

Paris, France

GSK Investigational Site

Toulouse, France

GSK Investigational Site

Cologne, Germany

GSK Investigational Site

Düsseldorf, Germany

GSK Investigational Site

Mainz, Germany

GSK Investigational Site

Minden, Germany

GSK Investigational Site

Tübingen, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Heraklion Crete, Greece

GSK Investigational Site

Larissa, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

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

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Modena, Italy

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Orbassano to, Italy

GSK Investigational Site

Padova, Italy

GSK Investigational Site

Pavia, Italy

GSK Investigational Site

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

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Miyagi, Japan

GSK Investigational Site

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

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NCT05878717


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