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

NCT06572384 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2216722024-513018-36-00
• Study Type: interventional
• Target: 440
• Locations: 18 countries
• Sites: 131

Brief 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.

Conditions

Lung Diseases, Interstitial

Keywords

Interstitial lung disease; Belimumab; Connective Tissue Disease; Autoimmune disease; Lung Diseases; Lung Diseases, Interstitial; Safety; Efficacy; Monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52

  Forced vital capacity is the total amount of air exhaled during the lung function test. Low FVC (mL) reflects more impaired lung function. Absolute Change from Baseline in FVC will be reported.

  Baseline and Week 52

Secondary Outcomes (20)

• Absolute Change from Baseline in FVC Percentage (%) Predicted at Week 52

  Baseline and Week 52

• Time to ILD Progression or Death

  From the date of assignment (Day 1) 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 Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 52

  Baseline and Week 52

• Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score at Week 52

  Baseline and Week 52

• Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) 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

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (131)

GSK Investigational Site

Los Angeles, California, 90033, United States

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GSK Investigational Site

Los Angeles, California, 90095, United States

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GSK Investigational Site

Los Angeles, California, 92868, United States

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GSK Investigational Site

San Francisco, California, 94143, United States

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GSK Investigational Site

Upland, California, 91786, United States

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GSK Investigational Site

Gainesville, Florida, 32608, United States

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GSK Investigational Site

Naples, Florida, 34102, United States

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GSK Investigational Site

St Louis, Missouri, 63110, United States

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GSK Investigational Site

New York, New York, 10029, United States

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GSK Investigational Site

New York, New York, 10032, United States

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GSK Investigational Site

Potsdam, New York, 13676, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Temple, Texas, 76508, United States

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GSK Investigational Site

Salt Lake City, Utah, 84108, United States

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GSK Investigational Site

Buenos Aires, 1023, Argentina

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GSK Investigational Site

Buenos Aires, C1128AAF, Argentina

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GSK Investigational Site

Buenos Aires, C1425AGC, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

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GSK Investigational Site

Córdoba, X5000AAW, Argentina

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GSK Investigational Site

Mendoza, 5500, Argentina

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GSK Investigational Site

Rosario, S2002, Argentina

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GSK Investigational Site

San Miguel de Tucumán, T4000, Argentina

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GSK Investigational Site

Santa Fe, 3000, Argentina

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GSK Investigational Site

Adelaide, South Australia, 5000, Australia

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GSK Investigational Site

Woodville, South Australia, 5011, Australia

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GSK Investigational Site

Spearwood, Western Australia, 6163, Australia

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GSK Investigational Site

Brussels, 1090, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Liège, 4000, Belgium

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GSK Investigational Site

Namur, Belgium

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GSK Investigational Site

Barra Mansa, 27323240, Brazil

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GSK Investigational Site

Juiz de Fora, 36010-570, Brazil

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GSK Investigational Site

Porto Alegre, 90020-090, Brazil

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GSK Investigational Site

Porto Alegre, 90480000, Brazil

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GSK Investigational Site

São José do Rio Preto, 15090-000, Brazil

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GSK Investigational Site

São Paulo, 04004-030, Brazil

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GSK Investigational Site

São Paulo, 05403-900, Brazil

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GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G9A 4P3, Canada

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GSK Investigational Site

Beijing, 100020, China

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GSK Investigational Site

Beijing, 100730, China

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GSK Investigational Site

Chengdu, 610072, China

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GSK Investigational Site

Guangzhou, 510100, China

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GSK Investigational Site

Guangzhou, 510630, China

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GSK Investigational Site

Hangzhou, 310003, China

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GSK Investigational Site

Hangzhou, 310052, China

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GSK Investigational Site

Mianyang, China

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GSK Investigational Site

Nanjing, 210008, China

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GSK Investigational Site

Nanjing, 210029, China

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GSK Investigational Site

Nanning, 530000, China

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GSK Investigational Site

Shanghai, 200001, China

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GSK Investigational Site

Shanghai, 200040, China

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GSK Investigational Site

Shenyang, 110001, China

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GSK Investigational Site

Suzhou, China

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GSK Investigational Site

Tianjin, 300052, China

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GSK Investigational Site

Zhuzhou, 412007, China

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GSK Investigational Site

Angers, 49933, France

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GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Pessac, 33604, France

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GSK Investigational Site

Rouen, 76000, France

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GSK Investigational Site

Toulouse, 31059, France

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GSK Investigational Site

Essen, 45293, Germany

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GSK Investigational Site

Mainz, 55131, Germany

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GSK Investigational Site

Minden, 32429, Germany

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GSK Investigational Site

Würzburg, 97080, Germany

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GSK Investigational Site

Athens, 106 76, Greece

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GSK Investigational Site

Athens, 124 62, Greece

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GSK Investigational Site

Athens, 12462, Greece

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GSK Investigational Site

Larissa, 41110, Greece

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GSK Investigational Site

Ancona, Italy

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GSK Investigational Site

Milan, 20132, Italy

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GSK Investigational Site

Milan, Italy

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GSK Investigational Site

Modena, 41124, Italy

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GSK Investigational Site

Naples, 80131, Italy

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GSK Investigational Site

Padua, Italy

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GSK Investigational Site

Pavia, 27100, Italy

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GSK Investigational Site

Pisa, 56126, Italy

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GSK Investigational Site

Roma, 00128, Italy

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GSK Investigational Site

Roma, Italy

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GSK Investigational Site

Udine, 33100, Italy

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GSK Investigational Site

Verona, 37134, Italy

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GSK Investigational Site

Aichi, 470-1192, Japan

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GSK Investigational Site

Fukuoka, 807-8556, Japan

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GSK Investigational Site

Fukuoka, 812-8582, Japan

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GSK Investigational Site

Hiroshima, 734-8551, Japan

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GSK Investigational Site

Hokkaido, 060-8648, Japan

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GSK Investigational Site

Kanagawa, 216-8511, Japan

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GSK Investigational Site

Miyagi, 983-8512, Japan

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GSK Investigational Site

Miyazaki, 889-1692, Japan

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GSK Investigational Site

Saitama, 350-0495, Japan

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GSK Investigational Site

Tokyo, 113-8519, Japan

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GSK Investigational Site

Tokyo, 113-8603, Japan

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GSK Investigational Site

Tokyo, 143-8541, Japan

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GSK Investigational Site

Tottori, 683-8504, Japan

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GSK Investigational Site

Yamanashi, 409-3898, Japan

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GSK Investigational Site

Chihuahua City, 31000, Mexico

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GSK Investigational Site

Guadalajara, 44650, Mexico

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GSK Investigational Site

Mexicali, 21200, Mexico

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GSK Investigational Site

Mexico City, 03310, Mexico

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GSK Investigational Site

Mérida, CP 97070, Mexico

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GSK Investigational Site

Monterrey, 64460, Mexico

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GSK Investigational Site

Maastricht, 6229 HX, Netherlands

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GSK Investigational Site

Rotterdam, 3015 GD, Netherlands

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GSK Investigational Site

Utrecht, 3584 CX, Netherlands

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GSK Investigational Site

Panama City, 07126, Panama

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GSK Investigational Site

Panama City, 7002, Panama

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GSK Investigational Site

Panama City, 7099, Panama

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GSK Investigational Site

Panama City, Panama

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GSK Investigational Site

Panama City, Panama

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GSK Investigational Site

Bucheon Kyunggi-Do, 420-717, South Korea

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GSK Investigational Site

Seoul, 05505, South Korea

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GSK Investigational Site

Seoul, 06351, South Korea

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GSK Investigational Site

Seoul, 06591, South Korea

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GSK Investigational Site

Suwon Kyunggi-do, 443-721, South Korea

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GSK Investigational Site

Yongsan-Ku Seoul, South Korea

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GSK Investigational Site

Barcelona, 08025, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Córdoba, 14004, Spain

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GSK Investigational Site

Granada, 18016, Spain

WITHDRAWN

GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Málaga, 29530, Spain

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GSK Investigational Site

Pamplona, 31008, Spain

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GSK Investigational Site

Santander, 39011, Spain

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GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Birmingham, B9 5SS, United Kingdom

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GSK Investigational Site

Leicester, LE3 9QP, United Kingdom

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GSK Investigational Site

London, SW3 6NP, United Kingdom

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MeSH Terms

Conditions

Lung Diseases, Interstitial; Connective Tissue Diseases; Autoimmune Diseases; Lung Diseases

Interventions

belimumab

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a two-group parallel study.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 27, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): October 18, 2028
• Study Completion (Estimated): December 13, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-03

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

US (16); AU (3); PA (5); DE (4); BE (4); KR (6); NL (3); ME (6); GB (3); JP (14); GR (4); IT (12); BR (7); ES (10); AR (9); CA (2); CN (17); FR (6)