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NCT06572384PHASE3Recruiting

A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

GlaxoSmithKline

Start Date

9/11/2024

Completion Date

12/13/2028

Summary

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * Participants with persistent/worsening active inflammatory disease who have failed to achieve their treatment goal, i. e., those who have experience lack of expected treatment benefit (clinically meaningful improvement in FVC), fail to demonstrate sustained lung function stability or continue to experience worsening of ILD despite initiation of standard therapy or failed to tolerate standard therapy. * Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis, dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria * Diagnosis of inflammatory and/or fibrotic ILD on High Resolution Computed Tomography (HRCT) with a total disease extent of greater than or equal to (≥) 10% of the whole lung * Evidence of persistent active/worsening ILD * Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate standard therapy. * 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 nonchildbearing potential (WONCBP) OR * Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<)1% * Capable of giving signed informed consent Exclusion Criteria: * Diagnosis of ILD other than CTD-ILD. * Primary diagnosis of Systemic Sclerosis (SSc). * Participants with rapidly progressive disease (absolute drop of 10% or more of FVC between screening and baseline visit and/or recent pulmonary hospitalization). * FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted at screening as confirmed by central reader * History or presence of diffuse alveolar hemorrhage (DAH) or other confounding pulmonary disease, signs, or symptoms * Pulmonary arterial hypertension requiring therapy, as determined by the investigator at, or prior to first day of dosing (Day 1) * Dependence on continuous oxygen supplementation * 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 Forced Expiratory Volume (FEV1) /FVC \<0.7) as confirmed by central reader * Significant emphysema on screening or historical HRCT (extent of emphysema exceeds extent of ILD) as confirmed by central reader * Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms * Participants with patient health questionnaire (PHQ-9) score ≥10, that in the opinion of a mental healthcare professional pose a serious suicide risk, have or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk. * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Breast cancer within the past 10 years * Major surgery (including joint surgery) within 3 months prior to screening or planned during the duration of the study * An active infection, or a history of infections

Interventions

BIOLOGICAL

Belimumab

OTHER

Placebo

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Conditions

Lung Diseases, Interstitial

Locations

GSK Investigational Site

Los Angeles, California 90033

United States

GSK Investigational Site

Los Angeles, California 90095

United States

GSK Investigational Site

Los Angeles, California 92868

United States

GSK Investigational Site

San Francisco, California 94143

United States

GSK Investigational Site

Upland, California 91786

United States

GSK Investigational Site

Gainesville, Florida 32608

United States

GSK Investigational Site

Naples, Florida 34102

United States

GSK Investigational Site

St Louis, Missouri 63110

United States

GSK Investigational Site

New York, New York 10029

United States

GSK Investigational Site

New York, New York 10032

United States

GSK Investigational Site

Potsdam, New York 13676

United States

GSK Investigational Site

Durham, North Carolina 27710

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19140

United States

GSK Investigational Site

Houston, Texas 77030

United States

GSK Investigational Site

Temple, Texas 76508

United States

GSK Investigational Site

Salt Lake City, Utah 84108

United States

GSK Investigational Site

Buenos Aires, 1023

Argentina

GSK Investigational Site

Buenos Aires, C1128AAF

Argentina

GSK Investigational Site

Buenos Aires, C1425AGC

Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO

Argentina

GSK Investigational Site

Córdoba, X5000AAW

Argentina

GSK Investigational Site

Mendoza, 5500

Argentina

GSK Investigational Site

Rosario, S2002

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000

Argentina

GSK Investigational Site

Santa Fe, 3000

Argentina

GSK Investigational Site

Adelaide, South Australia 5000

Australia

GSK Investigational Site

Woodville, South Australia 5011

Australia

GSK Investigational Site

Spearwood, Western Australia 6163

Australia

GSK Investigational Site

Brussels, 1090

Belgium

GSK Investigational Site

Brussels, 1200

Belgium

GSK Investigational Site

Liège, 4000

Belgium

GSK Investigational Site

Namur,

Belgium

GSK Investigational Site

Barra Mansa, 27323240

Brazil

GSK Investigational Site

Juiz de Fora, 36010-570

Brazil

GSK Investigational Site

Porto Alegre, 90020-090

Brazil

GSK Investigational Site

Porto Alegre, 90480000

Brazil

GSK Investigational Site

São José do Rio Preto, 15090-000

Brazil

GSK Investigational Site

São Paulo, 04004-030

Brazil

GSK Investigational Site

São Paulo, 05403-900

Brazil

GSK Investigational Site

Montreal, Quebec H3T 1E2

Canada

GSK Investigational Site

Trois-Rivières, Quebec G9A 4P3

Canada

GSK Investigational Site

Beijing, 100020

China

GSK Investigational Site

Beijing, 100730

China

GSK Investigational Site

Chengdu, 610072

China

GSK Investigational Site

Guangzhou, 510100

China

GSK Investigational Site

Guangzhou, 510630

China

GSK Investigational Site

Hangzhou, 310003

China

GSK Investigational Site

Hangzhou, 310052

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

Suzhou,

China

GSK Investigational Site

Tianjin, 300052

China

GSK Investigational Site

Zhuzhou, 412007

China

GSK Investigational Site

Angers, 49933

France

GSK Investigational Site

Le Kremlin-Bicêtre, 94275

France

GSK Investigational Site

Lille, 59037

France

GSK Investigational Site

Pessac, 33604

France

GSK Investigational Site

Rouen, 76000

France

GSK Investigational Site

Toulouse, 31059

France

GSK Investigational Site

Essen, 45293

Germany

GSK Investigational Site

Mainz, 55131

Germany

GSK Investigational Site

Minden, 32429

Germany

GSK Investigational Site

Würzburg, 97080

Germany

GSK Investigational Site

Athens, 106 76

Greece

GSK Investigational Site

Athens, 124 62

Greece

GSK Investigational Site

Athens, 12462

Greece

GSK Investigational Site

Larissa, 41110

Greece

GSK Investigational Site

Ancona,

Italy

GSK Investigational Site

Milan, 20132

Italy

GSK Investigational Site

Milan,

Italy

GSK Investigational Site

Modena, 41124

Italy

GSK Investigational Site

Naples, 80131

Italy

GSK Investigational Site

Padova,

Italy

GSK Investigational Site

Pavia, 27100

Italy

GSK Investigational Site

Pisa, 56126

Italy

GSK Investigational Site

Roma, 00128

Italy

GSK Investigational Site

Roma,

Italy

GSK Investigational Site

Udine, 33100

Italy

GSK Investigational Site

Verona, 37134

Italy

GSK Investigational Site

Aichi, 470-1192

Japan

GSK Investigational Site

Fukuoka, 807-8556

Japan

GSK Investigational Site

Fukuoka, 812-8582

Japan

GSK Investigational Site

Hiroshima, 734-8551

Japan

GSK Investigational Site

Hokkaido, 060-8648

Japan

GSK Investigational Site

Kanagawa, 216-8511

Japan

GSK Investigational Site

Miyagi, 983-8512

Japan

GSK Investigational Site

Miyazaki, 889-1692

Japan

GSK Investigational Site

Saitama, 350-0495

Japan

GSK Investigational Site

Tokyo, 113-8519

Japan

GSK Investigational Site

Tokyo, 113-8603

Japan

GSK Investigational Site

Tokyo, 143-8541

Japan

GSK Investigational Site

Tottori, 683-8504

Japan

GSK Investigational Site

Yamanashi, 409-3898

Japan

GSK Investigational Site

Chihuahua City, 31000

Mexico

GSK Investigational Site

Guadalajara, 44650

Mexico

GSK Investigational Site

Mexicali, 21200

Mexico

GSK Investigational Site

Mexico City, 03310

Mexico

GSK Investigational Site

Mérida, CP 97070

Mexico

GSK Investigational Site

Monterrey, 64460

Mexico

GSK Investigational Site

Maastricht, 6229 HX

Netherlands

GSK Investigational Site

Rotterdam, 3015 GD

Netherlands

GSK Investigational Site

Utrecht, 3584 CX

Netherlands

GSK Investigational Site

Panama City, 07126

Panama

GSK Investigational Site

Panama City, 7002

Panama

GSK Investigational Site

Panama City, 7099

Panama

GSK Investigational Site

Panama City,

Panama

GSK Investigational Site

Panama City,

Panama

GSK Investigational Site

Bucheon Kyunggi-Do, 420-717

South Korea

GSK Investigational Site

Seoul, 05505

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Seoul, 06591

South Korea

GSK Investigational Site

Suwon Kyunggi-do, 443-721

South Korea

GSK Investigational Site

Yongsan-Ku Seoul,

South Korea

GSK Investigational Site

Barcelona, 08025

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Córdoba, 14004

Spain

GSK Investigational Site

Granada, 18016

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Málaga, 29530

Spain

GSK Investigational Site

Pamplona, 31008

Spain

GSK Investigational Site

Santander, 39011

Spain

GSK Investigational Site

Seville, 41013

Spain

GSK Investigational Site

Birmingham, B9 5SS

United Kingdom

GSK Investigational Site

Leicester, LE3 9QP

United Kingdom

GSK Investigational Site

London, SW3 6NP

United Kingdom