Back to resultsAtacicept in Subjects With Active Lupus Nephritis (COMPASS) (COMPASS)
Primary Purpose
Lupus Nephritis (LN)
Status
Suspended
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atacicept
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis (LN) focused on measuring Systemic Lupus erythematosus (SLE), estimated glomerular filtration rate (eGFR), protenuria
Eligibility Criteria
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
Sites / Locations
- Vera Site # 0139
- Vera Site # 0138
- Vera Site # 0127
- Vera Site # 0129
- Vera Site # 0135
- Vera Site # 0136
- Vera Site # 0130
- Vera Site # 0131
- Vera Site # 0143
- Vera Site # 0140
- Vera Site # 0128
- Vera Site # 0134
- Vera Site # 0137
- Vera Site # 0144
- Vera Site # 0147
- Vera Site # 0109
- Vera Site # 0133
- Vera Site # 0149
- Vera Site # 0146
- Vera Site # 0142
- Vera Site # 0148
- Vera Site # 0145
- Vera SIte # 0132
- Vera Site # 0125
- Vera Site # 0126
- Vera Site # 0122
- Vera Site # 0141
- Vera Site # 0348
- Vera Site # 0347
- Vera Site # 0349
- Vera Site #0351
- Vera Site # 0350
- Vera Site # 0346
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atacicept Dose
Placebo to match Atacicept
Arm Description
Atacicept Dose once weekly subcutaneous (SC) Injection
Placebo to match Atacicept once weekly subcutaneous (SC) injection
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
Renal Response with alternative success criteria
Time to UPCR of≤0.5 mg/mg
Renal Response at Week 104
Time to Death or Renal-Related Event
Full Information
NCT ID
NCT05609812
First Posted
November 2, 2022
Last Updated
June 30, 2023
Sponsor
Vera Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05609812
Brief Title
Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
Acronym
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Study recruitment is paused due to business reasons, but not due to regulatory or safety concerns.
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
March 15, 2026 (Anticipated)
Study Completion Date
December 15, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vera Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis (LN)
Keywords
Systemic Lupus erythematosus (SLE), estimated glomerular filtration rate (eGFR), protenuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atacicept Dose
Arm Type
Experimental
Arm Description
Atacicept Dose once weekly subcutaneous (SC) Injection
Arm Title
Placebo to match Atacicept
Arm Type
Placebo Comparator
Arm Description
Placebo to match Atacicept once weekly subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Atacicept
Other Intervention Name(s)
VT-001
Intervention Description
Once weekly subcutaneous (SC) injections by prefilled syringe
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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%
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Renal Response with alternative success criteria
Time Frame
Weeks 52 and 104
Title
Time to UPCR of≤0.5 mg/mg
Time Frame
Week 52
Title
Renal Response at Week 104
Time Frame
Week 104
Title
Time to Death or Renal-Related Event
Time Frame
Week 104
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Curley
Organizational Affiliation
Chief Development Officer
Official's Role
Study Director
Facility Information:
Facility Name
Vera Site # 0139
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Vera Site # 0138
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Vera Site # 0127
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Vera Site # 0129
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Vera Site # 0135
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Vera Site # 0136
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Vera Site # 0130
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91321
Country
United States
Facility Name
Vera Site # 0131
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Vera Site # 0143
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Vera Site # 0140
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Vera Site # 0128
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Vera Site # 0134
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Vera Site # 0137
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Vera Site # 0144
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Vera Site # 0147
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Vera Site # 0109
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Vera Site # 0133
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Vera Site # 0149
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Vera Site # 0146
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Vera Site # 0142
City
New York
State/Province
New York
ZIP/Postal Code
10039
Country
United States
Facility Name
Vera Site # 0148
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Vera Site # 0145
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Vera SIte # 0132
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Vera Site # 0125
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Vera Site # 0126
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Vera Site # 0122
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Vera Site # 0141
City
Coto Laurel
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Vera Site # 0348
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Vera Site # 0347
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Vera Site # 0349
City
Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Vera Site #0351
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Vera Site # 0350
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Vera Site # 0346
City
Valencia
ZIP/Postal Code
4601
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://veratx.com
Description
Vera Therapeutics, Inc. Company Website
Learn more about this trial
Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
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