WithdrawnPhase 3

Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

Stopped: Study recruitment is paused due to business reasons, but not due to regulatory or safety concerns.

United States0Started 2022-11-02

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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 m2.
✕. 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

What they're measuring

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%

Timeframe: Week 52

Trial details

NCT IDNCT05609812

SponsorVera Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-15

View on ClinicalTrials.gov More Lupus Nephritis (LN) trials