Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

• Status: Recruiting
• Trial end date: 2028-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vera Therapeutics, Inc.

Criteria

Key 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