Full name

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) (BEconneCTD-ILD)

NCT Number
NCT06572384
Primary Endpoints

Primary:

  • Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52

Secondary:

  • Absolute Change from Baseline in FVC Percentage (%) Predicted at Week 52
  • Time to ILD Progression or Death. From the date of assignment (Day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
  • Absolute Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 52
  • Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score at Week 52
  • Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
  • Absolute Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52
  • Achieving Greater than or Equal (≥) 2% Decrease in QILD-WL Score at Week 52
  • Achieving Relative Decline from Baseline in FVC (mL) ≥ 5% at Week 52
  • Achieving Relative Decline from Baseline in FVC (mL) ≥ 10% at Week 52
  • Absolute Change from Baseline in Steroid Dose (Prednisone Equivalent Dose) at Week 52
  • Time to Connective Tissue Disease Progression. Up to 52 Weeks
  • Absolute Change from Baseline in Transition Dyspnea Index (TDI) at Week 52
  • Absolute Change from Baseline in Short Form Health Survey 36-Item Version 2 (SF36-v2) at Week 52
  • Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Impacts Total Score at Week 52
  • Absolute Change from Baseline in Kings Brief Interstitial Lung Disease Questionnaire (K-BILD) at Week 52
  • Absolute Change from Baseline in Physician Global Assessment (PhGA) at Week 52
  • Absolute Change in Patient Global Impression of Change (PGIC)-ILD at Week 52
  • Absolute Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) % Predicted at Week 52
  • Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs). Up to Week 60
  • Number of Participants with Respiratory Related Hospitalizations up to Week 52
External Link
https://clinicaltrials.gov/study/NCT06572384
Order
1
Disease
CTD-ILD
Menu title
BEconneCTD-ILD: A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease (CTD-ILD)
Version
ASN 2025
Phase
3
Status
Recruiting
Compound name
Belimumab
MoA
anti-BLyS mAb
Unmet Burden Fact
  • US estimated prevalence of CTD-ILD is 121.4 per 100,000 adults (including SSc-ILD) and 102.4 per 100,000 adults (excluding SSc-ILD); reflecting roughly 322,006 people (271,611 when excluding  SSc-ILD
Unmet Burden Fact Reference

Data on File 2024N558220_00

Study Description

The BEconneCTD-ILD Study will assess whether treatment of participants with Interstitial Lung Disease Associated with Connective Tissue Disease (CTD-ILD) 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.