Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
- Registration Number
- NCT05609812
- Lead Sponsor
- Vera Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 360
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo to match Atacicept Placebo Placebo to match Atacicept once weekly subcutaneous (SC) injection Atacicept Dose Atacicept Atacicept Dose once weekly subcutaneous (SC) Injection
- Primary Outcome Measures
Name Time Method 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
Name Time Method Time to Death or Renal-Related Event Week 104 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
Trial Locations
- Locations (33)
Vera Site # 0131
🇺🇸Torrance, California, United States
Vera Site # 0125
🇺🇸Dallas, Texas, United States
Vera Site # 0128
🇺🇸Miami, Florida, United States
Vera Site # 0109
🇺🇸Chicago, Illinois, United States
Vera Site # 0133
🇺🇸Las Vegas, Nevada, United States
Vera Site # 0148
🇺🇸Cleveland, Ohio, United States
Vera Site # 0139
🇺🇸Huntsville, Alabama, United States
Vera Site # 0349
🇪🇸Coruna, Spain
Vera Site # 0136
🇺🇸Northridge, California, United States
Vera Site # 0122
🇺🇸El Paso, Texas, United States
Vera Site # 0141
🇵🇷Coto Laurel, Puerto Rico
Vera Site # 0138
🇺🇸La Jolla, California, United States
Vera Site # 0129
🇺🇸Long Beach, California, United States
Vera Site # 0127
🇺🇸La Palma, California, United States
Vera Site # 0135
🇺🇸Northridge, California, United States
Vera Site # 0130
🇺🇸Santa Clarita, California, United States
Vera Site # 0143
🇺🇸New Haven, Connecticut, United States
Vera Site # 0140
🇺🇸Gainesville, Florida, United States
Vera Site # 0134
🇺🇸Atlanta, Georgia, United States
Vera Site # 0137
🇺🇸Augusta, Georgia, United States
Vera Site # 0144
🇺🇸Augusta, Georgia, United States
Vera Site # 0147
🇺🇸Lawrenceville, Georgia, United States
Vera Site # 0149
🇺🇸Summit, New Jersey, United States
Vera Site # 0146
🇺🇸New York, New York, United States
Vera Site # 0142
🇺🇸New York, New York, United States
Vera SIte # 0132
🇺🇸Jackson, Tennessee, United States
Vera Site # 0145
🇺🇸Columbus, Ohio, United States
Vera Site # 0126
🇺🇸Dallas, Texas, United States
Vera Site # 0348
🇪🇸Barcelona, Spain
Vera Site # 0347
🇪🇸Barcelona, Spain
Vera Site #0351
🇪🇸Santander, Spain
Vera Site # 0350
🇪🇸Sevilla, Spain
Vera Site # 0346
🇪🇸Valencia, Spain