Full name

A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants With Early Systemic Lupus Erythematosus (SLE) (BE-EARLY)

NCT Number
NCT06411249
Primary Endpoints

Primary:

  • Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52

Secondary:

  • Part A: Percentage of Participants Achieving SLE Responder Index 4 (SRI4) at Week 52
  • Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) for ≥ 25 percent (%) of time from Day 1 to Week 52
  • Part A: Percentage of Participants Achieving Average Oral Prednisone Equivalent Dose ≤ 5 mg/day at Week 52
  • Part A: Estimate of probability of having a Severe Flare defined as modified SELENA-SLEDAI Flare Index (SFI) at Week 52
  • Part A: Percentage of Participants Achieving a ≥ 50% Improvement in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score at Week 52
  • Part A: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue at Week 52
  • Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) up to Week 52
  • Part B: Percentage of Participants Achieving Definition of Remission in SLE (DORIS) Remission at Week 104
  • Part B: Percentage of Participants Maintaining Systematic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) of 0 up to Week 156
  • Part B: Number of Participants With AEs, SAEs, and AESIs up to Week 104 and Week 156
Order
1
Disease
SLE
Menu title
BE-EARLY: A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
Version
ACR 2025
Phase
4
Status
Recruiting
Compound name
Belimumab
MoA
anti-BLyS mAb
Unmet Burden Fact
  • Approximately 40% of patients with SLE develop organ damage within 5 years of diagnosis. 
  • Organ damage may lead to further damage, and has been associated with increased risk of mortality in SLE
     
Unmet Burden Fact Reference

Urowitz MB, et al. Arthritis Care Res. 2012;64:132

Study Description

The BE-EARLY Study is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.