Monthly Dosing of Atacicept in IgAN

Phase 2

Recruiting

• Conditions: IgA Nephropathy (IgAN); Berger Disease
• Interventions: Drug: Atacicept

• Registration Number: NCT07020923
• Lead Sponsor: Vera Therapeutics, Inc.

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

Detailed Description

This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.

Study Timeline

• Study First Submitted: 2025-05-13
• Study Start: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-24
• Primary Completion: 2026-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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
• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atacicept Arm 1	Atacicept	Atacicept dose A administered subcutaneous (sc) injection monthly

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN	Up to 24 weeks	Gd-IgA1 levels through Week 24

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of atacicept at different dosing regimensT	Baseline until end of study up to Week 24	Incidence of treatment emergent reported Adverse Events (AE)
To evaluate the effect of atacicept on serum immunoglobulins (IgA)	24 Weeks	IgA levels through Week 24
To evaluate the effect of atacicept on serum immunoglobulins (IgG)	24 Weeks	IgG levels through Week 24
To evaluate the effect of atacicept on serum immunoglobulins (IgM)	24 Weeks	IgM levels through Week 24
To evaluate serum PK of atacicept	Baseline until end of study up to Week 24	Serum concentration of atacicept

Trial Locations

Locations (1)

Vera Therapeutics; 🇺🇸 Brisbane, California, United States