A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

Vera Therapeutics Inc.12 sites in 5 countries23 target enrollmentJanuary 31, 2025

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Vera Therapeutics Inc.
Enrollment: 23
Locations: 12
Primary Endpoint: Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the long-term safety and tolerability of atacicept.

Registry

euclinicaltrials.eu

Start Date

January 31, 2025

End Date

TBD

Last Updated

last year

Investigators

Sponsor

Vera Therapeutics Inc.

Responsible Party

Principal Investigator

Regulatory

Scientific

Vera Therapeutics Inc.

Eligibility Criteria

Inclusion Criteria

•Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments.
•Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN.
•For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg at screening and Day
•A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative urine pregnancy test at Day 1), is not breastfeeding (for at least three months prior to screening), and at least one of the following conditions applies: *Is not a woman of childbearing potential (WOCBP) OR *Is a WOCBP who agrees to use a highly effective contraceptive method (ie, has a failure rate of less than 1% per year) at least 7 days prior to enrollment, through 175 days after the last dose of study drug.
•For Atacicept Drug Holiday Group only: eGFR ≥ 20 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
•For Atacicept Drug Holiday Group only: On a stable prescribed regimen of renin-angiotensin-aldosterone system inhibitor (ACEi or ARB) per guidance and local standard of care that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1.

Exclusion Criteria

•For Group 1 Atacicept Drug Holiday: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening).
•For Group 1 Atacicept Drug Holiday: History of acute or chronic infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus. • Participants who are positive hepatitis B surface antigen (HBsAg) are excluded • Participants who are HBsAg negative, hepatitis B core antibody (HBcAb) positive, hepatitis B surface antibody (HBsAb) positive with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring through safety follow up. • Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
•For Group 1 Atacicept Drug Holiday: History of splenectomy.
•For Group 1 Atacicept Drug Holiday: History of malignancy (hematologic or solid tumor) within 5 years prior to Day 1, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix
•For Group 1 Atacicept Drug Holiday: Known hypersensitivity to atacicept or any component of the formulated atacicept
•For Group 1 Atacicept Drug Holiday: Major surgery within 6 weeks prior to screening or planned/expected major surgery during the study period (including the safety follow-up period) - Major surgery often involves opening one of the major body cavities (abdomen or chest) and/or use of general anesthesia. Types of surgery that have the highest risk include heart or lung, liver, abdomen, or major operations on the bones and joints (eg, hip replacement). Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
•For Group 1 Atacicept Drug Holiday: Clinically significant history of alcohol or drug abuse in the 1 year prior to Day 1 as per Investigator opinion
•For Group 1 Atacicept Drug Holiday: Unwillingness or lack of capacity to follow all study procedures
•For Group 1 Atacicept Drug Holiday: Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to screening
•For Group 1 Atacicept Drug Holiday: Total urine protein excretion ≥5g per 24-hour or UPCR ≥5 mg/mg based on a 24-hour urine sample during the Screening Period

Outcomes

Primary Outcomes

Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events

Secondary Outcomes

The effect of atacicept on the following: *Changes in proteinuria based on UPCR and UACR as determined by spot urine. *Changes in estimated glomerular filtration rate (eGFR) based on serum creatinine and cystatin C, respectively. *Hematuria level based on blood on urine dipstick. *Changes in serum Gd-IgA1 levels.