A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vera Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

10 Oct 2025 → ongoing

Decision date (initial)

2025-09-27

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Vera Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others, Pharmacodynamic, Pharmacokinetic

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

Secondary objectives 5

1. Evaluate the safety and tolerability of atacicept at different dosing regimens
2. Evaluate the effect of atacicept on serum immunoglobulins
3. Evaluate serum PK of atacicept
4. Evaluate the immunogenicity of atacicept
5. Evaluate the effect of atacicept on change in proteinuria

Conditions and MedDRA coding

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

Study design 3 periods

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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
2. Diagnosis of IgAN as demonstrated by renal biopsy with total urine protein excretion ≥0.75 g per 24-hour or UPCR ≥0.75 mg/mg based on a 24-hour urine sample, and eGFR ≥30 ml/min/1.73m2
3. On a stable prescribed SoC regimen according to local practice listed in Section 4 of the protocol
4. Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at screening

Exclusion criteria 6

1. IgAN secondary to another condition or other causes of mesangial IgA deposition including IgA vasculitis, evidence of nephrotic syndrome within 6 months of screening, or concomitant chronic renal disease in addition to IgAN
2. Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
3. Active viral, bacterial or mycobacterial infections
4. Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in the study
5. Administration of live and live-attenuated vaccinations within 30 days prior to randomization
6. Known hypersensitivity to atacicept or any component of the formulated atacicept

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Gd-IgA1 levels through Week 24

Secondary endpoints 5

1. Incidence of treatment-emergent adverse events, and changes from baseline in routine laboratory and vital sign parameters
2. IgG, IgM, and IgA levels through Week 24
3. Serum concentration of atacicept through the end of study
4. Anti-drug antibody status through the end of study
5. UPCR values through the end of study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vera Therapeutics Inc.

Sponsor organisation

Vera Therapeutics Inc.

Address

2000 Sierra Point Parkway Suite 1200

City

Brisbane

Postcode

94005-1806

Country

United States

Scientific contact point

Organisation

Vera Therapeutics Inc.

Contact name

David Wilfret

Public contact point

Organisation

Vera Therapeutics Inc.

Contact name

Erin Collins

Third parties 8

Locations

2 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications