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

NCT06674577 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: VT-001-0051
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.

Conditions

IgA Nephropathy (IgAN); Renal and Urinary Disorders; Berger Disease

Keywords

IGA Glomerulonephritis; IGA Nephropathy; Iga Nephropathy 1; Immunoglobulin A Nephropathy Nephritis; IGA Type Nephropathy, IGA; renal and urinary disorders; Berger Disease; Berger's Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events observed during the dosing period

  Patient incidence of reported Adverse Events (AEs)

  Baseline until end of study up to week156

Secondary Outcomes (4)

• To evaluate the effect of atacicept on change in proteinuria

  Baseline until end of study up to week156

• To evaluate the effect of atacicept on the change in estimated glomerular filtration rate (eGFR) using serum creatinine and cystatin C, respectively

  Baseline until end of study up to week156

• To evaluate the effect of atacicept on hematuria

  Baseline until end of study up to week156

• To evaluate the effect of atacicept on serum galactose-deficient IgA1 (Gd-IgA1) levels

  Baseline until end of study up to week156

Study Arms (1)

Atacicept 150mg once weekly subcutaneous (SC) injection

EXPERIMENTAL

Other Names: VT-001

Drug: Atacicept 150 mg

Interventions

Atacicept 150 mg DRUG

The atacicept drug product is available as a ready to use injection solution in the following prefilled syringe (PFS) that is composed of: \*BD Hypak™ SCF™ Barrel Glass barrel 1ml long with staked needle 27G ½" 5B with Rigid Needle Shield BD260 \*BD SCF™ Stopper 1ml long W4023 Flurotec

Atacicept 150mg once weekly subcutaneous (SC) injection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤90mmHg at screening and Day 1
• 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.

You may not qualify if:

• Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
• For Atacicept Drug Holiday Group only: History of splenectomy
• Known hypersensitivity to atacicept or any component of the formulated atacicept
• For Atacicept Drug Holiday Group only: 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)
• Clinically significant history of alcohol or drug abuse in the 1 year prior to Day 1 as per Investigator opinion
• Unwillingness or lack of capacity to follow all study procedures
• For Atacicept Drug Holiday Group only: Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to screening
• Evidence of nephrotic syndrome (serum albumin \<30g/L in association with UPCR \>3.5 mg/mg) within 6 months of screening
• Currently on chronic dialysis, or expected to initiate dialysis within 12 weeks of screening
• Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants
• Clinically significant or predefined abnormalities per central laboratory tests at screening, meeting any of the criteria: Clinical evidence of immunosuppression and/or hypogammaglobulinemia as determined by the Investigator.
• For Atacicept Drug Holiday Group only: Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level \>2.5 × upper limit of normal (ULN) or total bilirubin \>1.5 x ULN. If the participant has a known history of Gilberts (history of isolated increase in total bilirubin without increase in liver transaminases), contact the Medical Monitor for further discussion.
• For Atacicept Drug Holiday Group only: Administration of live and live-attenuated vaccinations within 30 days prior to enrollment.
• For Atacicept Drug Holiday Group only: History or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis (MS) or optic neuritis (ON)
• Atacicept Drug Holiday Group only: If the participant is undergoing current treatment for latent tuberculosis infection (LTBI), they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to screening without evidence of re-exposure to be eligible for this study. If on LTBI treatment at the Screening visit, the participant will be expected to complete an appropriate LTBI treatment regimen to remain in the trial

Sponsors & Collaborators

• Vera Therapeutics, Inc.: lead

Study Sites (1)

Vera Therapeutics

Brisbane, California, 94005, United States

Location

Related Links

• Vera Therapeutics, Inc Company Website

MeSH Terms

Conditions

Glomerulonephritis, IGA; Urologic Diseases

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zeeshan Khawaja

  Vice President, Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)