Atacicept in Multiple Glomerular Diseases

Vera Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: FSGS; MCD; Nephrotic Syndrome; IgAN; pMN

Treatments: Drug: Atacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT06983028

VT-001-0060

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.

Full description

The study will assess the safety and efficacy of atacicept in multiple autoimmune glomerular diseases including IgAN (IgA Nephropathy), pMN (Primary Membranous Nephropathy) and MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis) in participants ages 10 and above with weekly SC injections.

Enrollment: 200 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Weight of at least 40 kg
• On a stable prescribed standard of care (SoC) treatment regimen according to local guidelines and the specific requirements for each disease
• Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at Screening. For participants aged ≥10 to <18 years, the average of 3 separate systolic and/or diastolic blood pressures <95th percentile for age, gender, and height

Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome

For patients enrolling in IgAN cohorts (eligibility varies by cohort):

• Age ≥ 10 years
• Biopsy proven IgAN or IgAVN,
• UPCR ≥ 0.5 g/g
• eGFR≥ 20 mL/min/1.73m2

For patients enrolling in pMN cohorts (eligibility varies by cohort):

• Age ≥ 18 years
• Biopsy-proven pMN
• Anti PLA2R antibodies ≥ 25 RU/mL
• UPCR ≥ 1.5 g/g
• At low risk for spontaneous remission (based on severity or duration of disease)

For patients enrolling in Nephrotic Syndrome cohorts (MCD, FSGS, or pediatric idiopathic nephrotic syndrome):

• Age ≥ 10 years
• eGFR≥30 mL/min/1.73m2
• Biopsy diagnosis of primary MCD or FSGS (adults) or challenging clinical course with steroids in children (frequenlty relapsing, steroid-dependent, or steroid-resistant)
• UPCR ≥ 1.0 g/g at Screening,
• Evidence of anti-nephrin antibodies
• Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 3 months prior to and at Screening)
• Active viral or bacterial infections
• Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
• Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
• Known hypersensitivity to atacicept or any component of the formulated atacicept
• Additional criteria apply to each cohort/disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

IgAN or IgAVN

Experimental group

Description:

Adult and pediatric patients with biopsy proven IgAN or IgAVN with varied severity of proteinuria and kidney function beyond what is currently included in most clinical trials. Adults with post-transplant IgAN recurrence are also included.

Treatment:

Drug: Atacicept

pMN

Experimental group

Description:

Adults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease.

Treatment:

Drug: Atacicept

Primary Nephrotic Syndrome (MCD/FSGS)

Experimental group

Description:

Adults with biopsy-proven primary MCD or FSGS and evidence of anti-nephrin antibodies. Children with frequently relapsing, steroid-dependent, or non-genetic steroid-resistant nephrotic syndrome with evidence of anti-nephrin antibodies.

Treatment:

Drug: Atacicept