Monthly Dosing of Atacicept in IgAN

NCT07020923 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: VT-001-0020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept

Conditions

IgA Nephropathy (IgAN); Berger Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN

  Gd-IgA1 levels through Week 24

  Up to 24 weeks

Secondary Outcomes (5)

• To evaluate the safety and tolerability of atacicept at different dosing regimensT

  Baseline until end of study up to Week 24

• To evaluate the effect of atacicept on serum immunoglobulins (IgA)

  24 Weeks

• To evaluate the effect of atacicept on serum immunoglobulins (IgG)

  24 Weeks

• To evaluate the effect of atacicept on serum immunoglobulins (IgM)

  24 Weeks

• To evaluate serum PK of atacicept

  Baseline until end of study up to Week 24

Study Arms (5)

Atacicept Arm 1

EXPERIMENTAL

Atacicept dose A administered subcutaneous (sc) injection monthly

Drug: Atacicept

Atacicept Arm 2

EXPERIMENTAL

Atacicept dose B administered subcutaneous (sc) injection monthly

Atacicept Arm 3

EXPERIMENTAL

Atacicept dose C administered subcutaneous (sc) injection monthly

Atacicept Arm 4

EXPERIMENTAL

Atacicept dose D administered subcutaneous (sc) injection weekly

Atacicept Arm 5

EXPERIMENTAL

Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections

Interventions

Atacicept DRUG

Drug: Atacicept

Also known as: VT-001

Atacicept Arm 1

Eligibility Criteria

• Age: 18 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
• Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
• Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
• Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
• eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
• On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1

You may not qualify if:

• IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis
• Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
• Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<3.0 g/dL in association with UPCR \>3.5 mg/mg)
• Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
• Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)

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

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 13, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)