Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05609812
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vera Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joanne Curley
Principal Investigator Affiliation Chief Development Officer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Puerto Rico, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis (LN)
Study Website: View Trial Website
Additional Details

The study will assess atacicept vs.#46; 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.

Arms & Interventions

Arms

Experimental: Atacicept Dose

Atacicept Dose once weekly subcutaneous (SC) Injection

Placebo Comparator: Placebo to match Atacicept

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Interventions

Drug: - Atacicept

Once weekly subcutaneous (SC) injections by prefilled syringe

Drug: - Placebo

placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vera Site # 0139, Huntsville, Alabama

Status

Not yet recruiting

Address

Vera Site # 0139

Huntsville, Alabama, 35805

Vera Site # 0138, La Jolla, California

Status

Not yet recruiting

Address

Vera Site # 0138

La Jolla, California, 92037

Vera Site # 0127, La Palma, California

Status

Recruiting

Address

Vera Site # 0127

La Palma, California, 90623

Vera Site # 0129, Long Beach, California

Status

Not yet recruiting

Address

Vera Site # 0129

Long Beach, California, 90822

Vera Site # 0135, Northridge, California

Status

Recruiting

Address

Vera Site # 0135

Northridge, California, 91324

Vera Site # 0136, Northridge, California

Status

Not yet recruiting

Address

Vera Site # 0136

Northridge, California, 91324

Vera Site # 0130, Santa Clarita, California

Status

Recruiting

Address

Vera Site # 0130

Santa Clarita, California, 91321

Vera Site # 0131, Torrance, California

Status

Not yet recruiting

Address

Vera Site # 0131

Torrance, California, 90502

Vera Site # 0143, New Haven, Connecticut

Status

Not yet recruiting

Address

Vera Site # 0143

New Haven, Connecticut, 06520

Vera Site # 0140, Gainesville, Florida

Status

Not yet recruiting

Address

Vera Site # 0140

Gainesville, Florida, 32610

Vera Site # 0128, Miami, Florida

Status

Not yet recruiting

Address

Vera Site # 0128

Miami, Florida, 33125

Vera Site # 0134, Atlanta, Georgia

Status

Not yet recruiting

Address

Vera Site # 0134

Atlanta, Georgia, 30309

Vera Site # 0137, Augusta, Georgia

Status

Not yet recruiting

Address

Vera Site # 0137

Augusta, Georgia, 30912

Vera Site # 0144, Augusta, Georgia

Status

Not yet recruiting

Address

Vera Site # 0144

Augusta, Georgia, 30912

Vera Site # 0147, Lawrenceville, Georgia

Status

Not yet recruiting

Address

Vera Site # 0147

Lawrenceville, Georgia, 30046

Vera Site # 0109, Chicago, Illinois

Status

Not yet recruiting

Address

Vera Site # 0109

Chicago, Illinois, 60611

Vera Site # 0133, Las Vegas, Nevada

Status

Not yet recruiting

Address

Vera Site # 0133

Las Vegas, Nevada, 89106

Vera Site # 0149, Summit, New Jersey

Status

Not yet recruiting

Address

Vera Site # 0149

Summit, New Jersey, 07901

Vera Site # 0146, New York, New York

Status

Not yet recruiting

Address

Vera Site # 0146

New York, New York, 10016

Vera Site # 0142, New York, New York

Status

Not yet recruiting

Address

Vera Site # 0142

New York, New York, 10039

Vera Site # 0148, Cleveland, Ohio

Status

Not yet recruiting

Address

Vera Site # 0148

Cleveland, Ohio, 44109

Vera Site # 0145, Columbus, Ohio

Status

Not yet recruiting

Address

Vera Site # 0145

Columbus, Ohio, 43210

Vera SIte # 0132, Jackson, Tennessee

Status

Not yet recruiting

Address

Vera SIte # 0132

Jackson, Tennessee, 38305

Vera Site # 0125, Dallas, Texas

Status

Not yet recruiting

Address

Vera Site # 0125

Dallas, Texas, 75231

Vera Site # 0126, Dallas, Texas

Status

Not yet recruiting

Address

Vera Site # 0126

Dallas, Texas, 75231

Vera Site # 0122, El Paso, Texas

Status

Not yet recruiting

Address

Vera Site # 0122

El Paso, Texas, 79925

International Sites

Vera Site # 0141, Coto Laurel, Puerto Rico

Status

Not yet recruiting

Address

Vera Site # 0141

Coto Laurel, , 00780

Vera Site # 0348, Barcelona, Spain

Status

Not yet recruiting

Address

Vera Site # 0348

Barcelona, , 08035

Vera Site # 0347, Barcelona, Spain

Status

Not yet recruiting

Address

Vera Site # 0347

Barcelona, , 08036

Vera Site # 0349, Coruna, Spain

Status

Not yet recruiting

Address

Vera Site # 0349

Coruna, , 15006

Vera Site #0351, Santander, Spain

Status

Not yet recruiting

Address

Vera Site #0351

Santander, , 39008

Vera Site # 0350, Sevilla, Spain

Status

Not yet recruiting

Address

Vera Site # 0350

Sevilla, , 41013

Vera Site # 0346, Valencia, Spain

Status

Not yet recruiting

Address

Vera Site # 0346

Valencia, , 4601