A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
NCT ID: NCT06572384
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
440 participants
INTERVENTIONAL
2024-09-11
2028-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Belimumab
Participants will receive belimumab in addition to standard therapy.
Belimumab
Belimumab will be administered.
Placebo
Participants will receive placebo in addition to standard therapy.
Placebo
Placebo will be administered.
Interventions
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Belimumab
Belimumab will be administered.
Placebo
Placebo will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Upland, California, United States
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Gainesville, Florida, United States
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Naples, Florida, United States
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St Louis, Missouri, United States
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New York, New York, United States
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New York, New York, United States
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Potsdam, New York, United States
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Durham, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Houston, Texas, United States
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Temple, Texas, United States
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Salt Lake City, Utah, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Adelaide, South Australia, Australia
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Woodville, South Australia, Australia
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Spearwood, Western Australia, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Barra Mansa, , Brazil
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Juiz de Fora, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Montreal, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Chengdu, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Mianyang, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Suzhou, , China
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Tianjin, , China
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Zhuzhou, , China
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Angers, , France
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Le Kremlin-Bicêtre, , France
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Lille, , France
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Pessac, , France
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Rouen, , France
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Toulouse, , France
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Essen, , Germany
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Mainz, , Germany
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Minden, , Germany
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Würzburg, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Larissa, , Greece
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Ancona, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Udine, , Italy
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Verona, , Italy
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Aichi, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Kanagawa, , Japan
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Miyagi, , Japan
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Miyazaki, , Japan
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Saitama, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tottori, , Japan
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Yamanashi, , Japan
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Mexicali, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Panama City, , Panama
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Panama City, , Panama
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Panama City, , Panama
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Panama City, , Panama
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Panama City, , Panama
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Bucheon Kyunggi-Do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon Kyunggi-do, , South Korea
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Yongsan-Ku Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Santander, , Spain
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Seville, , Spain
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Birmingham, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-513018-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
221672
Identifier Type: -
Identifier Source: org_study_id
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