Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

Vera Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Lupus Nephritis (LN)

Treatments: Drug: Placebo; Drug: Atacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT05609812

VT-001-0070

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

Atacicept Dose

Experimental group

Description:

Atacicept Dose once weekly subcutaneous (SC) Injection

Treatment:

Drug: Atacicept

Placebo to match Atacicept

Placebo Comparator group

Description:

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Treatment:

Drug: Placebo