Clinical trial NCT06983028: Atacicept in Multiple Glomerular Diseases
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: pMN
IgAN
Nephrotic Syndrome
MCD
FSGS
Keywords: IGA Glomerulonephritis
IGA Nephropathy
Iga Nephropathy 1
Immunoglobulin A Nephropathy Nephritis
IGA Type Nephropathy, IGA
Primary Membranous Nephropathy
Nephrotic Syndrome
Immunoglobulin A (IgA)
Immunoglobulin A vasculitis with nephritis (IgAVN)
Anti-PLA2R associated membranous nephropathy (PLA2R-MN)
Idiopathic/primary nephrotic syndrome (MCD/FSGS)
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Glomerulonephritis, IGA
Lead sponsor: Vera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: AE profile and results of routine clinical and laboratory tests
timeFrame: Baseline until end of study: 52 + 26 Weeks
measure: Percent reduction in urine protein to creatinine ratio (UPCR)
timeFrame: Baseline, Week 36
Secondary outcomes:
measure: Changes from baseline estimated glomerular filtration rate (eGFR).
timeFrame: Baseline, Week 36, Week 52
measure: Change in disease-specific antibodies
timeFrame: Baseline through 52 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Vera Therapeutics
name: Pam Winterberg
role: STUDY_DIRECTOR
References: