Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

Phase 3

Withdrawn

• Conditions: Lupus Nephritis (LN)
• Interventions: Drug: Placebo; Drug: Atacicept

• Registration Number: NCT05609812
• Lead Sponsor: Vera Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2022-11-02
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-08
• Status Verified: 2024-10
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-03-15
• Study Completion: 2028-12-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Male or Female at least 18 years of age at time of signing consent
2. Must have the ability to understand and sign and date a written informed consent form
3. Diagnosis of SLE
4. Biopsy- Proven Active LN
5. Requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN
6. Subject is willing to take oral MMF for the duration of the study

Key

Exclusion Criteria

1. eGFR of ≤30 mL/min/1.73 m2.
2. Sclerosis in 50% of glomeruli on renal biopsy.
3. Evidence of rapidly progressive glomerulonephritis.
4. Currently requiring renal dialysis or expected to require dialysis during the study.
5. Serum igG <7 g/L
6. Active infection or high infectious risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to match Atacicept	Placebo	Placebo to match Atacicept once weekly subcutaneous (SC) injection
Atacicept Dose	Atacicept	Atacicept Dose once weekly subcutaneous (SC) Injection

Primary Outcome Measures

Name	Time	Method
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%	Week 52

Secondary Outcome Measures

Name	Time	Method
Time to UPCR of≤0.5 mg/mg	Week 52
Time to Death or Renal-Related Event	Week 104
Renal Response with alternative success criteria	Weeks 52 and 104
Renal Response at Week 104	Week 104

Trial Locations

Locations (33)

Vera Site # 0139; 🇺🇸 Huntsville, Alabama, United States

Vera Site # 0138; 🇺🇸 La Jolla, California, United States

Vera Site # 0127; 🇺🇸 La Palma, California, United States

Vera Site # 0129; 🇺🇸 Long Beach, California, United States

Vera Site # 0135; 🇺🇸 Northridge, California, United States

Vera Site # 0136; 🇺🇸 Northridge, California, United States

Vera Site # 0130; 🇺🇸 Santa Clarita, California, United States

Vera Site # 0131; 🇺🇸 Torrance, California, United States

Vera Site # 0143; 🇺🇸 New Haven, Connecticut, United States

Vera Site # 0140; 🇺🇸 Gainesville, Florida, United States

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