A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Active Lupus Nephritis
Overview
- Phase
- Phase 3
- Intervention
- Atacicept
- Conditions
- Lupus Nephritis (LN)
- Sponsor
- Vera Therapeutics, Inc.
- Enrollment
- 360
- Locations
- 33
- Primary Endpoint
- Renal Response as definedas UPCR ≤0.5 mg/mg, and eGFR ≥60 mL/min/1.73 m^2 or eGFR <60 mL/min/1.73 m^2 with no confirmed decrease from baseline of >20%
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
Brief Summary
The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.
Detailed Description
The study will assess atacicept vs. placebo on the impact of renal function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female at least 18 years of age at time of signing consent
- •Must have the ability to understand and sign and date a written informed consent form
- •Diagnosis of SLE
- •Biopsy- Proven Active LN
- •Requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN
- •Subject is willing to take oral MMF for the duration of the study
Exclusion Criteria
- •eGFR of ≤30 mL/min/1.73 m
- •Sclerosis in 50% of glomeruli on renal biopsy.
- •Evidence of rapidly progressive glomerulonephritis.
- •Currently requiring renal dialysis or expected to require dialysis during the study.
- •Serum igG \<7 g/L
- •Active infection or high infectious risk
Arms & Interventions
Atacicept Dose
Atacicept Dose once weekly subcutaneous (SC) Injection
Intervention: Atacicept
Placebo to match Atacicept
Placebo to match Atacicept once weekly subcutaneous (SC) injection
Intervention: Placebo
Outcomes
Primary Outcomes
Renal Response as definedas UPCR ≤0.5 mg/mg, and eGFR ≥60 mL/min/1.73 m^2 or eGFR <60 mL/min/1.73 m^2 with no confirmed decrease from baseline of >20%
Time Frame: Week 52
Secondary Outcomes
- Time to Death or Renal-Related Event(Week 104)
- Renal Response with alternative success criteria(Weeks 52 and 104)
- Time to UPCR of≤0.5 mg/mg(Week 52)
- Renal Response at Week 104(Week 104)