Atacicept in Multiple Glomerular Diseases

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vera Therapeutics Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

12 Dec 2025 → ongoing

Decision date (initial)

2025-09-08

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Vera Therapeutics, Inc.

External identifiers

EU CT number

2024-518465-10-00

WHO UTN

U1111-1313-7595

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Efficacy, Therapy, Safety, Others

To evaluate the safety and tolerability of atacicept

To evaluate the effect of atacicept on change from baseline in proteinuria

To evaluate the PK of atacicept in children (pediatric cohorts IgAN-6, IgAN-8, and IgAN-9)

Secondary objectives 5

1. To evaluate the PK of atacicept
2. To evaluate the effect of atacicept on change from baseline in eGFR
3. To evaluate the effect of atacicept on percentage change from baseline in serum Gd-IgAI levels (IgAN cohorts), anti-PLA2R antibodies (pMN cohorts) and anti-nephrin antibodies (NS cohorts)
4. To evaluate the effect of atacicept on achieving proteinuria response
5. To evaluate the effect of atacicept on PD biomarkers of disease

Conditions and MedDRA coding

Multiple Autoimmune Glomerular Diseases

Study design 3 periods

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002004-PIP04-23

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. For All Participants: On a stable prescribed regimen of RAASi for at least 8 weeks that is at the maximum labeled or tolerated dose at Screening. (pMN-1: RAASi should be initiated per standard of care prior to Screening and should remain stable for the duration of the study; NS:RAASi, SGLT2i, MRA, ERA and/or GLP-1RA are permitted provided the dosing regimen is stable for at least 8 weeks prior to Screening and should remain stable for the duration of the study)
2. Systolic BP ≤160 mmHg and diastolic BP ≤90 mmHg at Screening.
3. Weight ≥40 kg at Screening (Weight ≥14 kg for IgAN 9 paeditric cohorts) Enrollment for pediatric participants <40 kg will open after interim analysis of PK and safety data. Enrollment of children age ≥2 to <10 years will be deferred pending interim analysis and iDMC review.
4. Willing to comply with the contraceptive guidelines of protocol
5. Additional criteria apply to each cohort/disease. Pease refer to study protocol for detailed criteria.

Exclusion criteria 9

1. For All Participants: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 12 weeks prior to and at Screening)
2. Severe kidney impairment (eGFR <15 mL/min/1.73 m2) or receiving dialysis or kidney replacement therapy or other organ transplantation prior to, or expected during the study, with the exception of corneal transplants
3. Mixed or multiple glomerulopathies >50% tubulointerstitial fibrosis or ≥ 25% cellular crescents on biopsy
4. Active viral or bacterial infections
5. Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
6. Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
7. Known hypersensitivity to atacicept or any component of the formulated atacicept
8. Concomitant or recent immunosuppression (except post-transplant IgAN cohort)
9. Additional criteria apply to each cohort/disease. Pease refer to study protocol for detailed criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. AE profile and results of routine clinical and laboratory tests through Week 52
2. Change from baseline in UPCR at Week 36
3. Serum concentration of atacicept through Week 24 (pediatric cohorts IgAN-6, IgAN-8, and IgAN-9)

Secondary endpoints 6

1. Changes from baseline in eGFR at Weeks 36 and 52
2. Changes from baseline in Gd-IgA1 at Weeks 36 and 52 (IgAN), or anti-PLA2R antibody titer at Weeks 4, 8, 12, 36, and 52 (pMN), or anti-nephrin (NS) antibody levels at Weeks 4, 8, 12, 36 and 52
3. Proportion of participants achieving proteinuria responses at Weeks 24, 36, and 52
4. Change from baseline in UPCR at Week 52 (IgAN cohorts), or Weeks 12, 24, and 52 (pMN and NS cohorts)
5. Serum concentration of atacicept through Week 52
6. Change from baseline in PD biomarkers (serum IgG, IgA, IgM, BAFF and APRIL) levels throught Week 52

Investigational products

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

Test 2

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

Pamela Winterberg

Public contact point

Organisation

Vera Therapeutics Inc.

Contact name

Jigisha Shah

Third parties 9

Locations

6 EU/EEA countries · 42 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 117 files

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

Application history

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