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

May 19, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vera Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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