Clinical trial • Phase II • Immunology|Rare Disease
ZIGAKIBART for IgA nephropathy
Phase II trial of ZIGAKIBART for IgA nephropathy. open-label. 17 participants.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- IgA nephropathy
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 05-11-2025
- First CTIS Authorization Date
- 17-03-2026
Trial design
open-label Phase II trial across 14 sites in Czechia, Germany, Italy and others.
- Open Label
- Yes
- Target Sample Size
- 17
- Trial Duration For Participant
- 728
Eligibility
Recruits 17 Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is handled via adult Main ICFs ("L1_ICF - Main ICF - Adult") submitted per country; additional consent-related documents exist for follow-up of pregnant participants and follow-up for pregnant partner of participant. Multiple country-specific ICF documents are provided (languages/countries include Czech, German, Italian, Spanish, Polish and English). No assent for minors is described in the available data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is handled via adult Main ICFs ("L1_ICF - Main ICF - Adult") submitted per country; additional consent-related documents exist for follow-up of pregnant participants and follow-up for pregnant partner of participant. Multiple country-specific ICF documents are provided (languages/countries include Czech, German, Italian, Spanish, Polish and English). No assent for minors is described in the available data.
Inclusion criteria
- {"criterion_text":"- Male or female adults 18 years of age or older who weigh at least 45 kg with a BMI no greater than 35.0 kg/m2 and were diagnosed with IgAN within the past 5 years."}
- {"criterion_text":"- Moderate kidney function (eGFR ≥45 mL/min/1.73 m²)."}
- {"criterion_text":"- Persistent protein in urine defined as total urine protein ≥0.5 g/day or urine protein-creatinine ratio (UPCR) ≥0.5 g/g despite supportive therapy, or total urine protein >1.5 g/day or UPCR >1.5 g/g at the time of clinical presentation or diagnosis if diagnosed within the past 6 months."}
Exclusion criteria
- {"criterion_text":"- Does not have IgA vasculitis."}
- {"criterion_text":"- Does not have a weakened immune system or unacceptably low immunoglobulin levels Total IgG (<6.0 g/L)."}
- {"criterion_text":"- Does not have urinary problems such as frequent urinary tract infections (UTIs) or trouble emptying the bladder."}
- {"criterion_text":"- Does not have high blood pressure that is not well controlled."}
- {"criterion_text":"- Has not used medications suppressing or affecting the immune system (not including short-term use of corticosteroids) in the past year."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in the level of IgA deposition in kidney tissue after 1 or 2 years of zigakibart treatment, compared to before treatment.","definition_or_measurement_approach":"Assessed by comparison to baseline kidney histology (kidney biopsy) after 1 or 2 years of treatment (histologic markers of IgA deposition)."}
Secondary endpoints
- {"endpoint_text":"- Clinical/laboratory assessments and adverse events.","definition_or_measurement_approach":"Clinical and laboratory assessments and recording of adverse events at scheduled visits during the study."}
- {"endpoint_text":"- Impact on immune response to vaccination, during the period of 6 to 23 months after the first treatment.","definition_or_measurement_approach":"Assessment of immune response to vaccination between 6 and 23 months after first treatment (measured by vaccine-specific immune assays as per protocol)."}
- {"endpoint_text":"- Kidney biopsy measures: changes in MEST- C score (an established measure of IgAN severity) and CD68 and C3c (inflammation markers), after 1 or 2 years of zigakibart treatment compared to before treatment.","definition_or_measurement_approach":"Histologic evaluation of kidney biopsy samples for MEST-C score and immunohistochemical/biomarker measures (CD68, C3c) comparing baseline to 1- and 2-year biopsies."}
- {"endpoint_text":"- Kidney function tests: urine protein and blood presence and estimated glomerular filtration rate (a blood test assessing kidney’s filtering function), at multiple timepoints during the 2- year zigakibart treatment compared to before treatment.","definition_or_measurement_approach":"Measurement of urine protein, hematuria, and eGFR at multiple timepoints during the 2-year treatment period versus baseline."}
- {"endpoint_text":"- IgAN markers in blood: Immunoglobulin levels (IgA, IgM, IgG) at multiple timepoints during the 2-year zigakibart treatment compared to before treatment.","definition_or_measurement_approach":"Serial blood measurements of immunoglobulin levels (IgA, IgM, IgG) at scheduled timepoints during 2-year treatment compared to baseline."}
- {"endpoint_text":"- Zigakibart concentrations in blood at multiple timepoints during the 2-year treatment.","definition_or_measurement_approach":"Pharmacokinetic sampling measuring zigakibart plasma concentrations at specified timepoints during treatment."}
- {"endpoint_text":"- Presence of antibodies against zigakibart in blood before and at multiple timepoints during the 2-year zigakibart treatment.","definition_or_measurement_approach":"Immunogenicity assessments for anti-drug antibodies pre-dose and at multiple timepoints during the 2-year treatment."}
Recruitment
- Planned Sample Size
- 17
- Recruitment Window Months
- 51
- Consent Approach
- Informed consent is obtained from adult participants (Main ICF - Adult). Country-specific ICFs are provided (documents available in Czech, German, Italian, Spanish, Polish and English). Additional participant information/ICF documents cover optional assessments, genetics, and follow-up for pregnant participants and pregnant partners. No assent for minors is described.
Methods
- K1_Recruitment Arrangements documents submitted per country (available for Czechia, Germany, Italy, Spain, Poland) - detailed channel/target descriptions not present in the raw JSON.
- K2_Advertisements documents present for some countries (Germany, Italy, Poland) indicating use of advertisements for recruitment - specific advertisement channels and target audience details are not provided in the raw JSON.
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 15
Czechia
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 3001: Klinika nefrologie
- Principal Investigator Name
- Vladimir Tesar
- Principal Investigator Email
- vladimir.tesar@vfn.cz
- Contact Person Name
- Vladimir Tesar
- Contact Person Email
- vladimir.tesar@vfn.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 47
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- #4003: Medizinische Klinik und Poliklinik IV
- Principal Investigator Name
- Volker Vielhauer
- Principal Investigator Email
- volker.vielhauer@med.uni-muenchen.de
- Contact Person Name
- Volker Vielhauer
- Contact Person Email
- volker.vielhauer@med.uni-muenchen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- #4002: Studienzentrum fuer Nieren- und Hochdruckerkrankungen
- Principal Investigator Name
- Jessica Kaufeld
- Principal Investigator Email
- Kaufeld.Jessica@mh-hannover.de
- Contact Person Name
- Jessica Kaufeld
- Contact Person Email
- Kaufeld.Jessica@mh-hannover.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- #4001: I. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Julia Weinmann-Menke
- Principal Investigator Email
- Julia.weinmann-menke@unimedizin-mainz.de
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- Julia.weinmann-menke@unimedizin-mainz.de
Italy
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 32
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- #5007: U.O. Nefrologia
- Principal Investigator Name
- Federico Alberici
- Principal Investigator Email
- federico.alberici@unibs.it
- Contact Person Name
- Federico Alberici
- Contact Person Email
- federico.alberici@unibs.it
- Site Name
- Istituto Di Ricerche Farmacologiche Mario Negri
- Department Name
- #5001:U.O. Malattie Renali
- Principal Investigator Name
- Matias Trillini
- Principal Investigator Email
- matias.trillini@marionegri.it
- Contact Person Name
- Matias Trillini
- Contact Person Email
- matias.trillini@marionegri.it
- Site Name
- Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit
- Department Name
- #5006: U.O. Nefrologia e Dialisi
- Principal Investigator Name
- Ciro Esposito
- Principal Investigator Email
- ciro.esposito@icsmaugeri.it
- Contact Person Name
- Ciro Esposito
- Contact Person Email
- ciro.esposito@icsmaugeri.it
Spain
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 26
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- 9004: Nefrología
- Principal Investigator Name
- María del Carmen Alarcón Garcelán
- Principal Investigator Email
- mcgarcelan@gmail.com
- Contact Person Name
- María del Carmen Alarcón Garcelán
- Contact Person Email
- mcgarcelan@gmail.com
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- 9002: Nefrología
- Principal Investigator Name
- Ana Isabel Ávila Bernabeu
- Principal Investigator Email
- avila_ana@gva.es
- Contact Person Name
- Ana Isabel Ávila Bernabeu
- Contact Person Email
- avila_ana@gva.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- 9001: Nefrología
- Principal Investigator Name
- Jose María Mora Gutiérrez
- Principal Investigator Email
- jmora@unav.es
- Contact Person Name
- Jose María Mora Gutiérrez
- Contact Person Email
- jmora@unav.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 9003: Nefrología
- Principal Investigator Name
- Luis Fernando Quintana Porras
- Principal Investigator Email
- lfquinta@clinic.cat
- Contact Person Name
- Luis Fernando Quintana Porras
- Contact Person Email
- lfquinta@clinic.cat
Poland
- Earliest CTIS Part Ii Submission Date
- 04-02-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 47
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- 7002 : Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnętrznych
- Principal Investigator Name
- Michał Nowicki
- Principal Investigator Email
- nefro@wp.pl
- Contact Person Name
- Michał Nowicki
- Contact Person Email
- nefro@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Opolu
- Department Name
- 7003 : Oddział Nefrologii ze Stacją Dializ
- Principal Investigator Name
- Tomasz Porażko
- Principal Investigator Email
- tomasz.porazko@usk.opole.pl
- Contact Person Name
- Tomasz Porażko
- Contact Person Email
- tomasz.porazko@usk.opole.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- 7001: Centralny Szpital Klinczny Oddział Kliniczny Nefrologii, Dializoterapii i Chorób Wewnętrznych
- Principal Investigator Name
- Jolanta Małyszko
- Principal Investigator Email
- knd.csk@uckwum.pl
- Contact Person Name
- Jolanta Małyszko
- Contact Person Email
- knd.csk@uckwum.pl
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Role code: 12
- Name
- Syneos Health Inc.
- Responsibilities
- Role code: 1
- Name
- IQVIA Limited
- Responsibilities
- Role code: 1
- Name
- Icon Clinical Research Limited
- Responsibilities
- Role code: 1
- Name
- 4g Clinical LLC
- Responsibilities
- Role code: 3
Third parties
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Translation services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Role code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Role code: 12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Role code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Role code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Role code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Role code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Nephropathology Associates PLC","duties_or_roles":"Role code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Role code: 4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Bion 1301/FUB523
- Active Substance
- ZIGAKIBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Maximum Dose
- 600 mg (max daily dose amount)
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