Atacicept in Subjects With Active Lupus Nephritis (COMPASS) (COMPASS)

June 30, 2023 updated by: Vera Therapeutics, Inc.

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Coto Laurel, Puerto Rico, 00780
        • Vera Site # 0141
  • Spain
      • Barcelona, Spain, 08035
        • Vera Site # 0348
      • Barcelona, Spain, 08036
        • Vera Site # 0347
      • Coruna, Spain, 15006
        • Vera Site # 0349
      • Santander, Spain, 39008
        • Vera Site #0351
      • Sevilla, Spain, 41013
        • Vera Site # 0350
      • Valencia, Spain, 4601
        • Vera Site # 0346
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Vera Site # 0139
    • California
      • La Jolla, California, United States, 92037
        • Vera Site # 0138
      • La Palma, California, United States, 90623
        • Vera Site # 0127
      • Long Beach, California, United States, 90822
        • Vera Site # 0129
      • Northridge, California, United States, 91324
        • Vera Site # 0135
      • Northridge, California, United States, 91324
        • Vera Site # 0136
      • Santa Clarita, California, United States, 91321
        • Vera Site # 0130
      • Torrance, California, United States, 90502
        • Vera Site # 0131
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Vera Site # 0143
    • Florida
      • Gainesville, Florida, United States, 32610
        • Vera Site # 0140
      • Miami, Florida, United States, 33125
        • Vera Site # 0128
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Vera Site # 0134
      • Augusta, Georgia, United States, 30912
        • Vera Site # 0137
      • Augusta, Georgia, United States, 30912
        • Vera Site # 0144
      • Lawrenceville, Georgia, United States, 30046
        • Vera Site # 0147
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Vera Site # 0109
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Vera Site # 0133
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Vera Site # 0149
    • New York
      • New York, New York, United States, 10016
        • Vera Site # 0146
      • New York, New York, United States, 10039
        • Vera Site # 0142
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Vera Site # 0148
      • Columbus, Ohio, United States, 43210
        • Vera Site # 0145
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Vera SIte # 0132
    • Texas
      • Dallas, Texas, United States, 75231
        • Vera Site # 0125
      • Dallas, Texas, United States, 75231
        • Vera Site # 0126
      • El Paso, Texas, United States, 79925
        • Vera Site # 0122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atacicept Dose
Atacicept Dose once weekly subcutaneous (SC) Injection
Drug: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Names:
  • VT-001
Placebo Comparator: Placebo to match Atacicept
Placebo to match Atacicept once weekly subcutaneous (SC) injection
Drug: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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%
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal Response with alternative success criteria
Time Frame: Weeks 52 and 104
Weeks 52 and 104
Time to UPCR of≤0.5 mg/mg
Time Frame: Week 52
Week 52
Renal Response at Week 104
Time Frame: Week 104
Week 104
Time to Death or Renal-Related Event
Time Frame: Week 104
Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vera Therapeutics, Inc.

Investigators

  • Study Director: Joanne Curley, Chief Development Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

December 15, 2028

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VT-001-0070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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