Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Jeff Golden
Headshot of Jeff Golden
Jeff Golden

Description

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.

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)

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join 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 hospitalisation).
  • FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted or requiring supplemental oxygen at screening
  • History or presence of diffuse alveolar haemorrhage (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 HRCT (extent of emphysema exceeds extent of ILD)
  • Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
  • Have evidence of moderate to severe depression, defined as PHQ-9 score ≥10, or serious current suicide risk, 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

Locations

  • GSK Investigational Site not yet accepting patients
    San Francisco California 94143 United States
  • GSK Investigational Site not yet accepting patients
    Los Angeles California 90033 United States
  • GSK Investigational Site accepting new patients
    Tottori 683-8504 Japan
  • GSK Investigational Site not yet accepting patients
    Yamanashi 409-3898 Japan

Lead Scientist at UCSF

  • Jeff Golden
    Professor, Medicine, School of Medicine. Authored (or co-authored) 223 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
GlaxoSmithKline
ID
NCT06572384
Phase
Phase 3 Interstitial Lung Disease Research Study
Study Type
Interventional
Participants
Expecting 440 study participants
Last Updated