RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2024-08-26
Study Completion:2028-12-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06572384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (≥) 10% of the whole lung (WLILD)
  3. * Evidence of ILD progression in the previous 24 months
  4. * 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.
  5. * 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
  6. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
  7. * Is a woman of nonchildbearing potential (WONCBP) OR
  8. * Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<)1%
  9. * Capable of giving signed informed consent
  1. * Diagnosis of ILD other than CTD-ILD.
  2. * Primary diagnosis of Systemic Sclerosis (SSc).
  3. * Participants with rapidly progressive disease (absolute drop of 10% or more of FVC between screening and baseline visit and/or recent pulmonary hospitalisation).
  4. * 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
  5. * History or presence of diffuse alveolar haemorrhage (DAH) or other confounding pulmonary disease, signs, or symptoms
  6. * Pulmonary arterial hypertension requiring therapy, as determined by the investigator at, or prior to first day of dosing (Day 1)
  7. * Dependence on continuous oxygen supplementation
  8. * 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
  9. * Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC \<0.7).
  10. * Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD)
  11. * Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
  12. * 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
  13. * 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
  14. * Breast cancer within the past 10 years
  15. * Major surgery (including joint surgery) within 3 months prior to screening or planned during the duration of the study
  16. * An active infection, or a history of infections

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Los Angeles, California, 90033
United States
GSK Investigational Site
Los Angeles, California, 90095
United States
GSK Investigational Site
Los Angeles, California, 92868
United States
GSK Investigational Site
San Francisco, California, 94143
United States
GSK Investigational Site
Upland, California, 91786
United States
GSK Investigational Site
Gainesville, Florida, 32608
United States
GSK Investigational Site
Naples, Florida, 34102
United States
GSK Investigational Site
Bay Saint Louis, Mississippi, 63110
United States
GSK Investigational Site
New York, New York, 10029
United States
GSK Investigational Site
New York, New York, 10032
United States
GSK Investigational Site
Potsdam, New York, 13676
United States
GSK Investigational Site
Durham, North Carolina, 27710
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
United States
GSK Investigational Site
Houston, Texas, 77030
United States
GSK Investigational Site
Temple, Texas, 76508
United States
GSK Investigational Site
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26
Study Completion Date2028-12-13

Study Record Updates

Study Start Date2024-08-26
Study Completion Date2028-12-13

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Lung Diseases, Interstitial