Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05609812

Acronym

COMPASS

Enrollment

Registered

2022-11-08

Start date

2022-11-02

Completion date

2028-12-15

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis (LN)

Keywords

Systemic Lupus erythematosus (SLE), estimated glomerular filtration rate (eGFR), protenuria

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.

Interventions

DRUGAtacicept

Once weekly subcutaneous (SC) injections by prefilled syringe

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Time to Death or Renal-Related Event	Week 104

Countries

Puerto Rico, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026