Clinical trial • Phase II • Nephrology|Rare Disease
ATACICEPT for IgA nephropathy (IgAN) | Berger disease
Phase II trial of ATACICEPT for IgA nephropathy (IgAN) | Berger disease.
Overview
- Trial Therapeutic Area
- Nephrology|Rare Disease
- Trial Disease
- IgA nephropathy (IgAN) | Berger disease
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 05-06-2025
- First CTIS Authorization Date
- 24-09-2025
Trial design
Randomised, open-label, atacicept administered in 5 treatment arms (atacicept 00 (cci) administered (cci) sc injection) — specific doses and some scheduling details are redacted/cci; dosing regimen described in title as monthly (every 4 weeks).-controlled Phase II trial in Spain, Poland.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Atacicept administered in 5 treatment arms (Atacicept 00 (CCI) administered (CCI) SC injection) — specific doses and some scheduling details are redacted/CCI; dosing regimen described in title as monthly (every 4 weeks).
- Target Sample Size
- 63
- Trial Duration For Participant
- 518
Eligibility
Recruits 63 Vulnerable population selected in the CTIS record. Trial enrolment limited to adults (≥18 years) who provide written informed consent. No additional details on assent or specific consent handling for vulnerable groups are provided in the supplied data..
- Vulnerable Population
- Vulnerable population selected in the CTIS record. Trial enrolment limited to adults (≥18 years) who provide written informed consent. No additional details on assent or specific consent handling for vulnerable groups are provided in the supplied data.
Inclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- On a stable prescribed SoC regimen according to local practice listed in Section 4 of the protocol"}
- {"criterion_text":"- Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at screening"}
Exclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)"}
- {"criterion_text":"- Active viral, bacterial or mycobacterial infections"}
- {"criterion_text":"- Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in the study"}
- {"criterion_text":"- Administration of live and live-attenuated vaccinations within 30 days prior to randomization"}
- {"criterion_text":"- Known hypersensitivity to atacicept or any component of the formulated atacicept"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Gd-IgA1 levels through Week 24","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events, and changes from baseline in routine laboratory and vital sign parameters","definition_or_measurement_approach":""}
- {"endpoint_text":"- IgG, IgM, and IgA levels through Week 24","definition_or_measurement_approach":""}
- {"endpoint_text":"- Serum concentration of atacicept through the end of study","definition_or_measurement_approach":""}
- {"endpoint_text":"- Anti-drug antibody status through the end of study","definition_or_measurement_approach":""}
- {"endpoint_text":"- UPCR values through the end of study","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 63
- Recruitment Window Months
- 23
- Consent Approach
- Written informed consent must be provided by the participant (adult ≥18) prior to any study assessments. Subject information and informed consent forms (L1_SIS and ICF) and informed consent aids are present in the dossier; documents are available in English, Polish and Spanish based on file listings. No paediatric assent procedures (no participants <18) are described in the supplied data.
Methods
- Innovative Trials Limited (United Kingdom) — Patient Recruitment (contact: lisa.mathews@innovativetrials.com)
- Q2BI Corp. (United States) — Third party managing EDC vendor (contact: Jaclyn.huang@q2bi.com)
- Greenphire LLC (United States) — Patient Reimbursement (contact: joseph.baeringer@greenphire.com)
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 63
Spain
- Earliest CTIS Part Ii Submission Date
- 16-09-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 139
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Nephrology
- Principal Investigator Name
- Lúis Fernando Quintana Porras
- Principal Investigator Email
- lfquinta@clinic.cat
- Contact Person Name
- Lúis Fernando Quintana Porras
- Contact Person Email
- lfquinta@clinic.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Nephrology
- Principal Investigator Name
- Jose María Mora Gutierrez
- Principal Investigator Email
- jmora@unav.es
- Contact Person Name
- Jose María Mora Gutierrez
- Contact Person Email
- jmora@unav.es
- Site Name
- Hospital Del Mar
- Department Name
- Nephrology
- Principal Investigator Name
- Eva Márquez Mosquera
- Principal Investigator Email
- eva.marquez.mosquera@psmar.cat
- Contact Person Name
- Eva Márquez Mosquera
- Contact Person Email
- eva.marquez.mosquera@psmar.cat
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Nephrology
- Principal Investigator Name
- Mercedes Salgueira Lazo
- Principal Investigator Email
- slag.investigacion.hvm.sspa@juntadeandalucia.es
- Contact Person Name
- Mercedes Salgueira Lazo
- Contact Person Email
- slag.investigacion.hvm.sspa@juntadeandalucia.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Nephrology
- Principal Investigator Name
- Cándido Díaz Rodríguez
- Principal Investigator Email
- candido.diazrodriguez@sergas.es
- Contact Person Name
- Cándido Díaz Rodríguez
- Contact Person Email
- candido.diazrodriguez@sergas.es
- Site Name
- Hospital Universitario Torrecardenas
- Department Name
- Nephrology
- Principal Investigator Name
- Francisco Javier González Martínez
- Principal Investigator Email
- fco.gonzalez.sspa@juntadeandalucia.es
- Contact Person Name
- Francisco Javier González Martínez
- Contact Person Email
- fco.gonzalez.sspa@juntadeandalucia.es
- Site Name
- Hospital Del Mar (duplicate listing resolved in source as separate site entry)
- Department Name
- Nephrology
- Principal Investigator Name
- Eva Márquez Mosquera
- Principal Investigator Email
- eva.marquez.mosquera@psmar.cat
- Contact Person Name
- Eva Márquez Mosquera
- Contact Person Email
- eva.marquez.mosquera@psmar.cat
Poland
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 147
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Chorób Wewnętrznych, Nefrologii i Transplantologii Klinicznej
- Principal Investigator Name
- Andrzej Rydzewski
- Principal Investigator Email
- andrzej.rydzewski@pimmswia.gov.pl
- Contact Person Name
- Andrzej Rydzewski
- Contact Person Email
- andrzej.rydzewski@pimmswia.gov.pl
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Department Name
- 4 Wojskowy Szpital Kliniczny z Polikliniką
- Principal Investigator Name
- Magdalena Krajewska
- Principal Investigator Email
- magdalena.krajewska@pwr.edu.pl
- Contact Person Name
- Magdalena Krajewska
- Contact Person Email
- magdalena.krajewska@pwr.edu.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
- Department Name
- Oddzial Kliniczny Nefrologii i Chorób Wewnetrznych
- Principal Investigator Name
- Ilona Kurnatowska
- Principal Investigator Email
- ilona.kurnatowska@umed.lodz.pl
- Contact Person Name
- Ilona Kurnatowska
- Contact Person Email
- ilona.kurnatowska@umed.lodz.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- Nephrology Clinic
- Principal Investigator Name
- Michal Nowicki
- Principal Investigator Email
- michal.nowicki@umed.lodz.pl
- Contact Person Name
- Michal Nowicki
- Contact Person Email
- michal.nowicki@umed.lodz.pl
Sponsor
Primary sponsor
- Full Name
- Vera Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Innovative Trials Limited
- Responsibilities
- Patient Recruitment
- Name
- Worldwide Clinical Trials d.o.o.
- Name
- Medidata Solutions Inc.
- Name
- Suvoda LLC
- Name
- PPD Global Central Labs
- Name
- Almac Clinical Services Limited
- Responsibilities
- Functional Secondary Packaging and Labelling; Finished Good Storage; Importation site and QP release site (for UK and EU)
- Name
- Greenphire LLC
- Responsibilities
- Patient Reimbursement
- Name
- Q2BI Corp.
- Responsibilities
- Third party managing EDC vendor
Third parties
- {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2BI Corp.","duties_or_roles":"Third party managing EDC vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Functional Secondary Packaging and Labelling; Finished Good Storage; Importation site and QP release site (for UK and EU)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Atacicept
- Active Substance
- ATACICEPT
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Unapproved product (Phase II study for an unapproved product)
- Orphan Designation
- Yes
- Frequency
- Every 4 weeks (monthly)
- Maximum Dose
- 600 mg (max daily); max total 7200 mg
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