Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lupus Nephritis (LN)

Intervention / Treatment
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* Drug: Atacicept
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atacicept Dose<br>Atacicept Dose once weekly subcutaneous (SC) Injection | Drug: Atacicept<br>* Once weekly subcutaneous (SC) injections by prefilled syringe<br>* Other names: VT-001;|
| Placebo Comparator: Placebo to match Atacicept<br>Placebo to match Atacicept once weekly subcutaneous (SC) injection | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Lupus erythematosus (SLE), estimated glomerular filtration rate (eGFR), protenuria