Clinical trial • Phase III • Immunology
ZIGAKIBART for IgA nephropathy
Phase III trial of ZIGAKIBART for IgA nephropathy. open-label, none/not specified-controlled. 151 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- IgA nephropathy
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 12-01-2026
- First CTIS Authorization Date
- 04-05-2026
Trial design
open-label, none/not specified-controlled Phase III trial across 34 sites in Belgium, Croatia, Czechia and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 151
- Trial Duration For Participant
- 672
Eligibility
Recruits 151 The application indicates vulnerable populations are selected (isVulnerablePopulationSelected:true). Signed informed consent must be obtained prior to participation in the OLE study. Country-specific consent documents include caregiver ICFs (e.g. "Caregiver-ICF_HRV") and pre-ICF telephone consent documents (e.g. "Scout Pre-ICF Telephone Consent"), and there are dedicated pregnant participant/partner ICFs; these documents indicate use of caregiver consent pathways and telephone pre-consent options where applicable..
- Pregnancy Exclusion
- Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
- Vulnerable Population
- The application indicates vulnerable populations are selected (isVulnerablePopulationSelected:true). Signed informed consent must be obtained prior to participation in the OLE study. Country-specific consent documents include caregiver ICFs (e.g. "Caregiver-ICF_HRV") and pre-ICF telephone consent documents (e.g. "Scout Pre-ICF Telephone Consent"), and there are dedicated pregnant participant/partner ICFs; these documents indicate use of caregiver consent pathways and telephone pre-consent options where applicable.
Inclusion criteria
- {"criterion_text":"- Signed informed consent must be obtained prior to participation in the OLE study.\n- Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol\n- Per Investigator’s clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W."}
Exclusion criteria
- {"criterion_text":"- Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason\n- Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.\n- History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart.\n- Confirmed IgG levels < 3 g/L prior to first study treatment administration in the OLE study.\n- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 24 weeks after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).\n- Sexually active males unwilling to use a highly effective methods of contraception during intercourse while taking study treatment and for 24 weeks after stopping study treatment. In addition, male participants must not donate sperm for the time period specified above.\n- Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥ 30 days) or who require kidney transplantation.\n- Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.\n- Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.\n- Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.\n- Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for > 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study.\n- Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.\n- Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction [PCR] will be allowed), or antibodies to HIV-1 and/or HIV-2.\n- Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score < 7 and prostate specific antigen < 10 ng/mL) are eligible for the study)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":"Collection and reporting of treatment-emergent adverse events (TEAEs) including type, incidence, severity, seriousness and assessment of relatedness to study treatment as recorded during the study."}
- {"endpoint_text":"- Incidence, severity, seriousness, and relatedness of adverse events of special interest (AESI)","definition_or_measurement_approach":"Collection and reporting of adverse events of special interest (AESI) including incidence, severity, seriousness and assessment of relatedness to study treatment as recorded during the study."}
Secondary endpoints
- {"endpoint_text":"- Change from Baseline to Weeks 48 and 96 in UPCR based on 24h-urine collection","definition_or_measurement_approach":"Change in urine protein-to-creatinine ratio (UPCR) from baseline to Weeks 48 and 96 measured using 24-hour urine collection."}
- {"endpoint_text":"- Change from Baseline to Week 96 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) from baseline to Week 96 calculated using the CKD-EPI creatinine equation."}
- {"endpoint_text":"- Change from BEYOND parent study Baseline to Week 96 of OLE study in eGFR","definition_or_measurement_approach":"Change in eGFR from the BEYOND parent study baseline to Week 96 of the OLE study (method as per eGFR assessments)."}
- {"endpoint_text":"- Serum concentrations of zigakibart","definition_or_measurement_approach":"Measurement of serum concentrations of zigakibart (PK sampling/assays) at scheduled timepoints."}
- {"endpoint_text":"- Changes from baseline in immunoglobulin levels","definition_or_measurement_approach":"Laboratory measurement of immunoglobulin levels and comparison to baseline values."}
- {"endpoint_text":"- Presence of circulating binding and neutralizing antidrug antibodies (ADA/Nab)","definition_or_measurement_approach":"Assessment of anti-drug antibodies (binding and neutralizing) using immunogenicity assays."}
- {"endpoint_text":"- Safety laboratory parameters and vital signs","definition_or_measurement_approach":"Routine safety laboratory testing and vital signs assessments per schedule to monitor safety."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 151
- Recruitment Window Months
- 77
- Consent Approach
- Signed informed consent must be obtained prior to participation. Pre-ICF telephone consent options are provided (documents titled 'Scout Pre-ICF Telephone Consent' are included for multiple countries). Country-specific informed consent forms and supplementary ICFs are provided (including caregiver ICFs and pregnant participant/partner ICFs). Consent documents are available in multiple languages as per the submission (examples: English, French, Dutch, German, Greek, Croatian, Czech, Italian, Spanish).
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 69
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 12
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Imelda
- Department Name
- Nephrology
- Principal Investigator Name
- Wim Lemahieu
- Principal Investigator Email
- wim.lemahieu@imelda.be
- Contact Person Name
- Wim Lemahieu
- Contact Person Email
- wim.lemahieu@imelda.be
- Site Name
- HUmani
- Department Name
- Nephrology
- Principal Investigator Name
- Aline Pourcelet
- Principal Investigator Email
- aline.pourcelet@chu-charleroi.be
- Contact Person Name
- Aline Pourcelet
- Contact Person Email
- aline.pourcelet@chu-charleroi.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Nephrology
- Principal Investigator Name
- Antoine Bouquegneau
- Principal Investigator Email
- antoine.bouquegneau@chuliege.be
- Contact Person Name
- Antoine Bouquegneau
- Contact Person Email
- antoine.bouquegneau@chuliege.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Nephrology
- Principal Investigator Name
- Nathalie Demoulin
- Principal Investigator Email
- nathalie.demoulin@saintluc.uclouvain.be
- Contact Person Name
- Nathalie Demoulin
- Contact Person Email
- nathalie.demoulin@saintluc.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Nephrology
- Principal Investigator Name
- Marijn Speeckaert
- Principal Investigator Email
- marijn.speeckaert@uzgent.be
- Contact Person Name
- Marijn Speeckaert
- Contact Person Email
- marijn.speeckaert@uzgent.be
Croatia
- Earliest CTIS Part Ii Submission Date
- 06-04-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Specijalna Bolnica Medico
- Principal Investigator Name
- Bozidar Vujicic
- Principal Investigator Email
- vujicic.bozidar@gmail.com
- Contact Person Name
- Bozidar Vujicic
- Contact Person Email
- vujicic.bozidar@gmail.com
- Site Name
- Poliklinika BONIFARM
- Principal Investigator Name
- Ivana Vukovic Brinar
- Principal Investigator Email
- ivemedex@yahoo.com
- Contact Person Name
- Ivana Vukovic Brinar
- Contact Person Email
- ivemedex@yahoo.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 08-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Všeobecná fakultní nemocnice v Praze Klinika nefrologie
- Principal Investigator Name
- Vladimir Tesař
- Principal Investigator Email
- vladimir.tesar@vfn.cz
- Contact Person Name
- Vladimir Tesař
- Contact Person Email
- vladimir.tesar@vfn.cz
France
- Earliest CTIS Part Ii Submission Date
- 05-03-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 60
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Service de Néphrologie
- Principal Investigator Name
- Pierre-Louis CARRON
- Principal Investigator Email
- PLCarron@chu-grenoble.fr
- Contact Person Name
- Pierre-Louis CARRON
- Contact Person Email
- PLCarron@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Néphrologie
- Principal Investigator Name
- Evangéline PILLEBOUT
- Principal Investigator Email
- evangeline.pillebout@aphp.fr
- Contact Person Name
- Evangéline PILLEBOUT
- Contact Person Email
- evangeline.pillebout@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Néphrologie
- Principal Investigator Name
- Sandrine LEMOINE
- Principal Investigator Email
- sandrine.lemoine01@chu-lyon.fr
- Contact Person Name
- Sandrine LEMOINE
- Contact Person Email
- sandrine.lemoine01@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service de Néphrologie – Dialyse - Transplantation
- Principal Investigator Name
- François GLOWACKI
- Principal Investigator Email
- francois.glowacki@chu-lille.fr
- Contact Person Name
- François GLOWACKI
- Contact Person Email
- francois.glowacki@chu-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Néphrologie - Transplantation rénale adultes
- Principal Investigator Name
- Myriam DAO
- Principal Investigator Email
- myriam.dao@aphp.fr
- Contact Person Name
- Myriam DAO
- Contact Person Email
- myriam.dao@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 13-03-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 54
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Barmherzige Brueder Trier gGmbH
- Department Name
- Innere Medizin II
- Principal Investigator Name
- Stefan Weiner
- Principal Investigator Email
- s.weiner@bbtgruppe.de
- Contact Person Name
- Stefan Weiner
- Contact Person Email
- s.weiner@bbtgruppe.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Nieren- und Hochdruckerkrankungen
- Principal Investigator Name
- Kai Martin Schmidt-Ott
- Principal Investigator Email
- schmidt-ott.kai@mh-hannover.de
- Contact Person Name
- Kai Martin Schmidt-Ott
- Contact Person Email
- schmidt-ott.kai@mh-hannover.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- II. Medizinische Klinik
- Principal Investigator Name
- Aydin Er
- Principal Investigator Email
- aydin.er@uk-augsburg.de
- Contact Person Name
- Aydin Er
- Contact Person Email
- aydin.er@uk-augsburg.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- Klinik für Nieren- und Hochdruckkrankheiten, Diabetologie & Endokrinologie
- Principal Investigator Name
- Peter Mertens
- Principal Investigator Email
- peter.mertens@med.ovgu.de
- Contact Person Name
- Peter Mertens
- Contact Person Email
- peter.mertens@med.ovgu.de
- Site Name
- Universitaetsklinikum Jena KöR
- Principal Investigator Name
- Martin Busch
- Principal Investigator Email
- martin.busch@med.uni-jena.de
- Contact Person Name
- Martin Busch
- Contact Person Email
- martin.busch@med.uni-jena.de
Greece
- Earliest CTIS Part Ii Submission Date
- 18-02-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 75
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- General Hospital Of Thessaloniki Agios Pavlos
- Department Name
- Renal Department
- Principal Investigator Name
- Sofia Spaia
- Principal Investigator Email
- spaiasofia@gmail.com
- Contact Person Name
- Sofia Spaia
- Contact Person Email
- spaiasofia@gmail.com
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- 2nd Department of Nephrology
- Principal Investigator Name
- Vassilios Liakopoulos
- Principal Investigator Email
- vliak@auth.gr
- Contact Person Name
- Vassilios Liakopoulos
- Contact Person Email
- vliak@auth.gr
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- Nephrology Unit
- Principal Investigator Name
- Sophia Lionaki
- Principal Investigator Email
- sofia.lionaki@gmail.com
- Contact Person Name
- Sophia Lionaki
- Contact Person Email
- sofia.lionaki@gmail.com
- Site Name
- General Hospital Of Ioannina G. Hatzikosta
- Department Name
- Nephrology Department
- Principal Investigator Name
- Emilios Andrikos
- Principal Investigator Email
- emilioandrikos@gmail.com
- Contact Person Name
- Emilios Andrikos
- Contact Person Email
- emilioandrikos@gmail.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Department of Nephrology
- Principal Investigator Name
- Evangelos Papachristou
- Principal Investigator Email
- epapadoct@hotmail.com
- Contact Person Name
- Evangelos Papachristou
- Contact Person Email
- epapadoct@hotmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 95
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- Nephrology, Dialysis and Transplantation Unit
- Principal Investigator Name
- Loreto Gesualdo
- Principal Investigator Email
- loreto.gesualdo@uniba.it
- Contact Person Name
- Loreto Gesualdo
- Contact Person Email
- loreto.gesualdo@uniba.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Division of Nephrology, Dialysis and Kidney Transplantation
- Principal Investigator Name
- Riccardo Magistroni
- Principal Investigator Email
- riccardo.magistroni@unimore.it
- Contact Person Name
- Riccardo Magistroni
- Contact Person Email
- riccardo.magistroni@unimore.it
- Site Name
- Istituti Clinici Scientifici Maugeri S.p.A. Sb
- Department Name
- U.O. di Nefrologia e Dialisi
- Principal Investigator Name
- Ciro Esposito
- Principal Investigator Email
- ciro.esposito@unipv.it
- Contact Person Name
- Ciro Esposito
- Contact Person Email
- ciro.esposito@unipv.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Unità operativa complessa di Nefrologia
- Principal Investigator Name
- Giuseppe Grandaliano
- Principal Investigator Email
- giuseppe.grandaliano@policlinicogemelli.it
- Contact Person Name
- Giuseppe Grandaliano
- Contact Person Email
- giuseppe.grandaliano@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- U.O.C. Nefrologia
- Principal Investigator Name
- Ivana Capuano
- Principal Investigator Email
- ivanacapuano@libero.it
- Contact Person Name
- Ivana Capuano
- Contact Person Email
- ivanacapuano@libero.it
- Site Name
- Azienda Sanitaria Universitaria Giuliano Isontina
- Department Name
- SC di Nefrologia e Dialisi
- Principal Investigator Name
- Vittorio Di Maso
- Principal Investigator Email
- vittorio.dimaso@asugi.sanita.fvg.it
- Contact Person Name
- Vittorio Di Maso
- Contact Person Email
- vittorio.dimaso@asugi.sanita.fvg.it
Spain
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 97
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Nephrology
- Principal Investigator Name
- Irene Agraz Pamplona
- Principal Investigator Email
- irene.agraz@vallhebron.cat
- Contact Person Name
- Irene Agraz Pamplona
- Contact Person Email
- irene.agraz@vallhebron.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Nephrology
- Principal Investigator Name
- Eduardo Gutierrez Martínez
- Principal Investigator Email
- eduardogutmat90@gmail.com
- Contact Person Name
- Eduardo Gutierrez Martínez
- Contact Person Email
- eduardogutmat90@gmail.com
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Nephrology
- Principal Investigator Name
- Ana Merino Ribas
- Principal Investigator Email
- amerinor.girona.ics@gencat.cat
- Contact Person Name
- Ana Merino Ribas
- Contact Person Email
- amerinor.girona.ics@gencat.cat
- Site Name
- Hospital De Manises
- Department Name
- Nephrology
- Principal Investigator Name
- Rafael García Maset
- Principal Investigator Email
- garcia_rafmas@gva.es
- Contact Person Name
- Rafael García Maset
- Contact Person Email
- garcia_rafmas@gva.es
- 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
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
- sponsorDuties codes: [12]; contact: Clinicaltrial.Enquiries@parexel.com
- Name
- PPD Global Ltd.
- Responsibilities
- sponsorDuties codes: [1]; contact: CRGApprovalsGR.sm@thermofisher.com
- Name
- PPD Development LP
- Responsibilities
- sponsorDuties codes: [1,13,2,4,5,8]; contact: crgeuctrinquiry.sm@thermofisher.com
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: [3]; contact: eu_clinical_trials_information@iqvia.com
- Name
- Labcorp Development (Asia) Pte Ltd
- Responsibilities
- sponsorDuties codes: [4]; contact: ChinHan.Cheng@labcorp.com
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: [7]; contact: info@medidata.com
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"World Courier Management Limited","duties_or_roles":"sponsorDuties codes: [15]; value: 24H urine collection sample pick up at patient home and delivery at site","organisation_type":"Health care"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties codes: [15]; value: Patient Travel reimbursment","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [1,13,2,4,5,8]","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Pharmacy Ioannis Emm Anagnostakis & Co OE","duties_or_roles":"sponsorDuties codes: [15]; value: Pregnancy tests vendor for Greek sites","organisation_type":"Health care"}
- {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Bion 1301/FUB523
- Active Substance
- ZIGAKIBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (prodAuthStatus:1)
- Orphan Designation
- Yes
- Starting Dose
- 600 mg s.c. Q2W
- Dose Levels
- 600 mg
- Frequency
- Q2W
- Maximum Dose
- 600 mg (maxDailyDoseAmount: 600 mg)
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