Clinical trial NCT07020923: Monthly Dosing of Atacicept in IgAN
Official title: A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: IgA Nephropathy (IgAN)
Berger Disease
Lead sponsor: Vera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: To evaluate the safety and tolerability of atacicept at different dosing regimensT
timeFrame: Baseline until end of study up to Week 24
measure: To evaluate the effect of atacicept on serum immunoglobulins (IgA)
timeFrame: 24 Weeks
measure: To evaluate the effect of atacicept on serum immunoglobulins (IgG)
timeFrame: 24 Weeks
measure: To evaluate the effect of atacicept on serum immunoglobulins (IgM)
timeFrame: 24 Weeks
measure: To evaluate serum PK of atacicept
timeFrame: Baseline until end of study up to Week 24
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Vera Therapeutics
state: California
Study officials:
affiliation: Vice President, Clinical Development
name: Zeeshan Khawaja
role: STUDY_DIRECTOR
References: