Last updated: 03/02/2026 18:20:08
A Study of the Efficacy and Safety of Belimumab in Adults with Interstitial Lung Disease Associated with Connective Tissue DiseaseBEconneCTD-ILD
GSK study ID
221672
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults with Interstitial Lung Disease (ILD) Associated with Connective Tissue Disease (CTD)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52
Timeframe: Baseline and Week 52
Secondary outcomes:
Absolute Change from Baseline in FVC Percentage (%) Predicted at Week 52
Timeframe: Baseline and Week 52
Time to ILD Progression or Death
Timeframe: 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
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score at Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Quantitative Ground Glass Opacity in the Whole Lung (QGGO-WL) at Week 52
Timeframe: Baseline and Week 52
Achieving Relative Decline from Baseline in FVC (mL) ≥ 5% at Week 52
Timeframe: Baseline and Week 52
Achieving Relative Decline from Baseline in FVC (mL) ≥ 10% at Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Steroid Dose (Prednisone Equivalent Dose) at Week 52
Timeframe: Baseline and Week 52
Time to Connective Tissue Disease Progression
Timeframe: Up to 52 Weeks
Absolute Change from Baseline in Transition Dyspnea Index (TDI) at Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Short Form Health Survey 36-Item Version 2 (SF36-v2) at Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Impacts Total Score at Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) at Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Physician Global Assessment (PhGA) at Week 52
Timeframe: Baseline and Week 52
Absolute Change in Patient Global Impression of Change (PGIC)-ILD at Week 52
Timeframe: Baseline and Week 52
Absolute Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) % Predicted at Week 52
Timeframe: Baseline and Week 52
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs)
Timeframe: Up to Week 60
Number of Participants with Respiratory Related Hospitalizations up to Week 52
Timeframe: Up to Week 52
Interventions:
Biological/vaccine: Belimumab
Other: Placebo
Enrollment:
440
Observational study model:
Not applicable
Primary completion date:
2028-18-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Diseases, Interstitial
Product
belimumab
Collaborators
Not applicable
Study date(s)
September 2024 to December 2028
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 ILD other than CTD-ILD.
- Primary diagnosis of Systemic Sclerosis (SSc).
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1128AAF
Status
Recruiting
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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