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

Launched by GLAXOSMITHKLINE · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called belimumab for adults with interstitial lung disease (ILD) linked to certain connective tissue diseases (CTDs), like rheumatoid arthritis and lupus. ILD can cause serious breathing problems and significantly affect quality of life. The researchers want to see if adding belimumab to the usual treatments can help improve lung function and reduce symptoms like shortness of breath and coughing.

To be eligible for this trial, participants need to have a confirmed diagnosis of a CTD and ILD that affects at least 10% of their lungs, as shown on a special lung scan. They should also have experienced some progression of their ILD in the past two years and be currently receiving stable treatment for their condition. Participants will take the study medication and may be asked to visit the clinic regularly for check-ups. It's important to note that certain health conditions may exclude someone from joining the trial, including severe lung or heart issues. Those who participate will help researchers understand how well belimumab works for this challenging condition.

Gender

ALL

Eligibility criteria

• 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 ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (≥) 10% of the whole lung (WLILD)
• • Evidence of ILD progression in the previous 24 months
• • Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate first line 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
• • 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).
• • Significant emphysema on screening or historical HRCT (extent of emphysema exceeds extent of ILD)
• • 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, or have 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