Evaluating Belimumab for Lung Disease Linked to Autoimmune Conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of belimumab, a medication used for autoimmune diseases, in adults suffering from interstitial lung disease (ILD) associated with connective tissue diseases (CTDs). Participants will receive either belimumab or a placebo alongside their standard therapy to determine if this treatment can stabilize or improve lung function and alleviate symptoms of ILD. The study aims to assess the impact of belimumab on lung health and quality of life in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Orange, California, United States Recruiting
• GSK Investigational Site
  San Francisco, California, United States Recruiting
• GSK Investigational Site
  Upland, California, United States Recruiting
• GSK Investigational Site
  Gainesville, Florida, United States Recruiting

+82 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.