Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

NCT ID: NCT05609812

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2028-12-15

Brief Summary

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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

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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.

Conditions

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Lupus Nephritis (LN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atacicept Dose

Atacicept Dose once weekly subcutaneous (SC) Injection

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

Once weekly subcutaneous (SC) injections by prefilled syringe

Placebo to match Atacicept

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Atacicept

Once weekly subcutaneous (SC) injections by prefilled syringe

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Other Intervention Names

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VT-001

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vera Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Curley

Role: STUDY_DIRECTOR

Chief Development Officer

Locations

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Vera Site # 0139

Huntsville, Alabama, United States

Site Status

Vera Site # 0138

La Jolla, California, United States

Site Status

Vera Site # 0127

La Palma, California, United States

Site Status

Vera Site # 0129

Long Beach, California, United States

Site Status

Vera Site # 0135

Northridge, California, United States

Site Status

Vera Site # 0136

Northridge, California, United States

Site Status

Vera Site # 0130

Santa Clarita, California, United States

Site Status

Vera Site # 0131

Torrance, California, United States

Site Status

Vera Site # 0143

New Haven, Connecticut, United States

Site Status

Vera Site # 0140

Gainesville, Florida, United States

Site Status

Vera Site # 0128

Miami, Florida, United States

Site Status

Vera Site # 0134

Atlanta, Georgia, United States

Site Status

Vera Site # 0137

Augusta, Georgia, United States

Site Status

Vera Site # 0144

Augusta, Georgia, United States

Site Status

Vera Site # 0147

Lawrenceville, Georgia, United States

Site Status

Vera Site # 0109

Chicago, Illinois, United States

Site Status

Vera Site # 0133

Las Vegas, Nevada, United States

Site Status

Vera Site # 0149

Summit, New Jersey, United States

Site Status

Vera Site # 0146

New York, New York, United States

Site Status

Vera Site # 0142

New York, New York, United States

Site Status

Vera Site # 0148

Cleveland, Ohio, United States

Site Status

Vera Site # 0145

Columbus, Ohio, United States

Site Status

Vera SIte # 0132

Jackson, Tennessee, United States

Site Status

Vera Site # 0125

Dallas, Texas, United States

Site Status

Vera Site # 0126

Dallas, Texas, United States

Site Status

Vera Site # 0122

El Paso, Texas, United States

Site Status

Vera Site # 0141

Coto Laurel, , Puerto Rico

Site Status

Vera Site # 0349

A Coruña, , Spain

Site Status

Vera Site # 0348

Barcelona, , Spain

Site Status

Vera Site # 0347

Barcelona, , Spain

Site Status

Vera Site #0351

Santander, , Spain

Site Status

Vera Site # 0350

Seville, , Spain

Site Status

Vera Site # 0346

Valencia, , Spain

Site Status

Countries

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United States Puerto Rico Spain

Related Links

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http://veratx.com

Vera Therapeutics, Inc. Company Website

Other Identifiers

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VT-001-0070

Identifier Type: -

Identifier Source: org_study_id

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