[BE-conneCTD ILD
Research type
Research Study
Full 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).
IRAS ID
1010296
Contact name
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
Connective tissue diseases (CTDs) are a group of rare diseases in which the immune system attacks the body’s own cells which causes tissue to become inflamed which can lead to permanent scar tissue. Interstitial lung disease (ILD) is a complication of CTDs which is caused by inflammation and formation of scar tissue in the lungs causing a loss of lung function. This study will test a drug called belimumab, The drug works by blocking the action of a particular protein called BLyS which may be involved in the development and worsening of interstitial lung disease associated with connective tissue disease. The purpose of the study is to test whether belimumab, in addition to standard therapy, is safe and effective in stabilizing or improving the lung function, and improving the quality of life of people with CTD-ILD.
The study will involve about 440 participants with CTD-ILD aged 18years or older, approximately 12 patients will be in the UK. It will
last for 66 weeks for each patient which includes a 6 week screening period, 52 weeks of treatment, and follow-up for 8 weeks.
belimumab is given as an injection under the skin. Participants will be randomly assigned to 1 of 2 different treatment groups in
addition to continuing with their usual CTD medications:
belimumab 200mg once weekly for 52 weeks or Placebo once weekly for 52 weeks
Tests undertaken will include, but are not limited to, blood tests (including optional genetic test to identify markers in specific genes),
urine tests, physical exams, lung function tests, lung CT scans, Electrocardiogram (ECG), and vital signs.
Participants will also complete questionaires about their quality of life.
Participants who complete the study and are not classed as a treatment failure will be offered to join an open label extension study where
all participants will receive belimumab 200mg injection once weekly.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0256
Date of REC Opinion
25 Oct 2024
REC opinion
Further Information Favourable Opinion