Full name

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD) (BLISSc-ILD)

NCT Number
NCT05878717
Primary Endpoints

Primary:

  • Absolute change from baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52

Secondary:

  • Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
  • Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
  • Time to Systemic Sclerosis (SSc) progression or death. From the date of assignment 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 FVC percentage (%) predicted at Week 52
  • Relative decline from baseline in FVC (mL) greater than or equal to (≥)5% at Week 52
  • Relative decline from baseline in FVC (mL) ≥10% at Week 52
  • Absolute change from baseline in mRSS at Week 26
  • Proportion of participants achieving ≥20% increase in mRSS at Week 26 & 52
  • Absolute change from baseline in Quantitative interstitial lung disease - whole lung (QILD-WL) at Week 52
  • Absolute change from baseline in Quantitative lung fibrosis - whole lung (QLF-WL) at Week 52
  • Proportion of participants achieving ≥2% increase in QILD at Week 52
  • Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52
  • Relative decline from baseline in DLco % predicted ≥15% at Week 52
  • Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
  • Absolute change from baseline in Scleroderma Skin Patient-Reported Outcome (SSPRO) at Week 52
  • Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
  • Absolute change from baseline in Short Form-36 Health Survey Questionnaire (SF-36) at Week 52
  • Absolute change from baseline in Patient Global Assessment of SSc Disease Activity (PtGA) at Week 52.
  • Absolute change from baseline in Physician global assessment (PhGA) at Week 52
  • Absolute change from baseline in Transition Dyspnea Index (TDI) at Week 52
  • Number of participants with Adverse Events (AEs), Adverse Events of special interest (AESIs) and Serious AEs (SAEs) up to Week 52
  • Absolute change from baseline in DLco % predicted at Week 52
External Link
https://clinicaltrials.gov/study/NCT05878717
Order
1
Disease
SSc-ILD
Menu title
BLISSc-ILD: A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Version
ASN 2025
Phase
2/3
Status
Recruiting
Compound name
Belimumab
MoA
anti-BLyS mAb
Unmet Burden Fact
  • Incidence of SSc is 10–50 cases per million people per year
  • ILD is a leading cause of morbidity and mortality in patients with SSc, with a 10-year mortality of 40%
     
Unmet Burden Fact Reference

Perelas A, et al. Lancet Respir Med. 2020;8:304–320

Study Description

The BLISSc-ILD Study  investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).