Clinical trial NCT05609812: Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lupus Nephritis (LN)
Keywords: Systemic Lupus erythematosus (SLE)
estimated glomerular filtration rate (eGFR)
protenuria
Lead sponsor: Vera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Renal Response with alternative success criteria
timeFrame: Weeks 52 and 104
measure: Time to UPCR of≤0.5 mg/mg
timeFrame: Week 52
measure: Renal Response at Week 104
timeFrame: Week 104
measure: Time to Death or Renal-Related Event
timeFrame: Week 104
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Vera Site # 0139
state: Alabama
city: La Jolla
country: United States
facility: Vera Site # 0138
state: California
city: La Palma
country: United States
facility: Vera Site # 0127
state: California
city: Long Beach
country: United States
facility: Vera Site # 0129
state: California
city: Northridge
country: United States
facility: Vera Site # 0135
state: California
city: Northridge
country: United States
facility: Vera Site # 0136
state: California
city: Santa Clarita
country: United States
facility: Vera Site # 0130
state: California
city: Torrance
country: United States
facility: Vera Site # 0131
state: California
city: New Haven
country: United States
facility: Vera Site # 0143
state: Connecticut
city: Gainesville
country: United States
facility: Vera Site # 0140
state: Florida
city: Miami
country: United States
facility: Vera Site # 0128
state: Florida
city: Atlanta
country: United States
facility: Vera Site # 0134
state: Georgia
city: Augusta
country: United States
facility: Vera Site # 0137
state: Georgia
city: Augusta
country: United States
facility: Vera Site # 0144
state: Georgia
city: Lawrenceville
country: United States
facility: Vera Site # 0147
state: Georgia
city: Chicago
country: United States
facility: Vera Site # 0109
state: Illinois
city: Las Vegas
country: United States
facility: Vera Site # 0133
state: Nevada
city: Summit
country: United States
facility: Vera Site # 0149
state: New Jersey
city: New York
country: United States
facility: Vera Site # 0146
state: New York
city: New York
country: United States
facility: Vera Site # 0142
state: New York
city: Cleveland
country: United States
facility: Vera Site # 0148
state: Ohio
city: Columbus
country: United States
facility: Vera Site # 0145
state: Ohio
city: Jackson
country: United States
facility: Vera SIte # 0132
state: Tennessee
city: Dallas
country: United States
facility: Vera Site # 0125
state: Texas
city: Dallas
country: United States
facility: Vera Site # 0126
state: Texas
city: El Paso
country: United States
facility: Vera Site # 0122
state: Texas
city: Coto Laurel
country: Puerto Rico
facility: Vera Site # 0141
city: Barcelona
country: Spain
facility: Vera Site # 0348
city: Barcelona
country: Spain
facility: Vera Site # 0347
city: Coruna
country: Spain
facility: Vera Site # 0349
city: Santander
country: Spain
facility: Vera Site #0351
city: Sevilla
country: Spain
facility: Vera Site # 0350
city: Valencia
country: Spain
facility: Vera Site # 0346
Study officials:
affiliation: Chief Development Officer
name: Joanne Curley
role: STUDY_DIRECTOR
References: