Clinical trial • Phase III • Rare Disease
NAVENIBART for Hereditary angioedema|Hereditary angioedema type I|Hereditary angioedema type II
Phase III trial of NAVENIBART for Hereditary angioedema|Hereditary angioedema type I|Hereditary angioedema type II.
Overview
- Trial Therapeutic Area
- Rare Disease
- Trial Disease
- Hereditary angioedema|Hereditary angioedema type I|Hereditary angioedema type II
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 03-10-2025
- First CTIS Authorization Date
- 09-02-2026
Trial design
Navenibart - matching placebo (placebo product listed in Part I; dose/schedule not specified in available data)-controlled Phase III trial in Austria, Bulgaria, Czechia and others.
- Comparator
- Navenibart - matching placebo (placebo product listed in Part I; dose/schedule not specified in available data)
- Target Sample Size
- 93
Eligibility
Recruits 93 paediatric patients.
- Vulnerable Population
- The trial includes vulnerable populations (minors/adolescents). Assent and parental/guardian consent processes are provided: adolescent assent documents (examples: 'Adolescent Assent 12 to 15', 'Adolescent Assent 16-17', 'Assent_14-17', 'Assent_12-13') and parent/guardian consent forms ('Parent', 'Parent Main') are included in the application materials. Separate ICFs for adults and pregnant partners and optional genetic ICFs are also provided.
Inclusion criteria
- {"criterion_text":"- Participants from STAR-0215-301 who met one of the following conditions: a.\tCompleted STAR-0215-301 through the Day 181 visit b.\tWithdrew from STAR-0215-301 but met the following criteria: i.\tReceived 2 doses of IP ii.\tcompleted ≥ 2 months of trial follow-up after the second dose of IP iii.\tMet other eligibility criteria as assessed by Investigator"}
Exclusion criteria
- {"criterion_text":"- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3) , idiopathic angioedema, or angioedema associated with urticaria."}
- {"criterion_text":"- Participation in an investigational clinical trial other than STAR-0215-301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent"}
- {"criterion_text":"- Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 30 days before Screening."}
- {"criterion_text":"- Known sensitivity to the ingredients in the formulation of IP"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events (TEAEs) as recorded/reported during the study."}
Secondary endpoints
- {"endpoint_text":"- Number of time-normalized investigator-confirmed HAE attacks","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of moderate or severe investigator-confirmed HAE attacks","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of investigator-confirmed HAE attacks that require on-demand treatment","definition_or_measurement_approach":""}
- {"endpoint_text":"- Percent reduction in monthly investigator-confirmed HAE attacks","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to first investigator-confirmed HAE attack after first dose","definition_or_measurement_approach":""}
- {"endpoint_text":"- The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate","definition_or_measurement_approach":"Response defined as ≥ 50%, ≥ 70% or ≥ 90% reduction in investigator-confirmed HAE attack rate."}
- {"endpoint_text":"- Number of participants with no investigator-confirmed HAE attacks","definition_or_measurement_approach":""}
- {"endpoint_text":"- Angioedema Quality of Life (AE-QoL) questionnaire total score","definition_or_measurement_approach":"Measured by the AE-QoL questionnaire total score."}
Recruitment
- Planned Sample Size
- 93
- Recruitment Window Months
- 63
- Consent Approach
- Informed consent is handled via subject information sheets and ICFs for adults; for minors/adolescents there are dedicated parent/guardian consent forms and age‑appropriate assent forms (documents present for ages including 12-13, 14-17, and 16-17). Optional genetic consent and pregnant partner information forms are also provided. Specific languages per country are not detailed in the available metadata, but multiple country-specific ICF/assent documents are present.
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 53
Austria
- Earliest CTIS Part Ii Submission Date
- 08-12-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 63
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Dermatologie und Venerologie
- Principal Investigator Name
- Birger Kränke
- Principal Investigator Email
- birger.kraenke@meduniqraz.at
- Contact Person Name
- Birger Kränke
- Contact Person Email
- birger.kraenke@meduniqraz.at
- Site Name
- Medical University Of Vienna
- Department Name
- Deparment of Dermatology
- Principal Investigator Name
- Tamar Kinaciyan
- Principal Investigator Email
- tamar.kinaciyan@meduniwien.ac.at
- Contact Person Name
- Tamar Kinaciyan
- Contact Person Email
- tamar.kinaciyan@meduniwien.ac.at
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 33
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Principal Investigator Name
- Anna Valerieva Dimitrova
- Principal Investigator Email
- anna.valerieva@gmail.com
- Contact Person Name
- Anna Valerieva Dimitrova
- Contact Person Email
- anna.valerieva@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Ustav klinické imunologie a alergologie
- Principal Investigator Name
- Irena Krčmová
- Principal Investigator Email
- irena.krcmova@fnhk.cz
- Contact Person Name
- Irena Krčmová
- Contact Person Email
- irena.krcmova@fnhk.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Ústav imunologie 2. LF UK a FN Motol
- Principal Investigator Name
- Marta Sobotková
- Principal Investigator Email
- maria.sobotkova@fnmotol.cz
- Contact Person Name
- Marta Sobotková
- Contact Person Email
- maria.sobotkova@fnmotol.cz
France
- Earliest CTIS Part Ii Submission Date
- 27-01-2026
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 17
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Internal medicine
- Principal Investigator Name
- Pierre-Yves Jeandel
- Principal Investigator Email
- jeandel.py@chu-nice.fr
- Contact Person Name
- Pierre-Yves Jeandel
- Contact Person Email
- jeandel.py@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- internal medicine department and clinical immunology outpatient clinic
- Principal Investigator Name
- Isabelle Boccon-Gibod
- Principal Investigator Email
- lboccon-gibod@chu-grenoble.fr
- Contact Person Name
- Isabelle Boccon-Gibod
- Contact Person Email
- lboccon-gibod@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Internal medicine
- Principal Investigator Name
- Olivier Fain
- Principal Investigator Email
- olivier.fain@aphp.fr
- Contact Person Name
- Olivier Fain
- Contact Person Email
- olivier.fain@aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Internal medicine
- Principal Investigator Name
- Stephane Gayet
- Principal Investigator Email
- stephane.gayet@ap-hm.fr
- Contact Person Name
- Stephane Gayet
- Contact Person Email
- stephane.gayet@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Internal medicine
- Principal Investigator Name
- David Launay
- Principal Investigator Email
- david.launay@univ-lille.fr
- Contact Person Name
- David Launay
- Contact Person Email
- david.launay@univ-lille.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 115
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Klinik für Kinder und Jugendmedizin, Angioödem-Ambulanz und interdisziplinäres HAE-Kompetenzzentrum
- Principal Investigator Name
- Emel Aygören-Pürsün
- Principal Investigator Email
- aygoeren@em.uni-frankfurt.de
- Contact Person Name
- Emel Aygören-Pürsün
- Contact Person Email
- aygoeren@em.uni-frankfurt.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Institut für Allergieforschung
- Principal Investigator Name
- Markus Magerl
- Principal Investigator Email
- marcus.magerl@charite.de
- Contact Person Name
- Markus Magerl
- Contact Person Email
- marcus.magerl@charite.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Dept. of Dermatology and Allergology
- Principal Investigator Name
- Bettina Wedi
- Principal Investigator Email
- wedi.bettina@mh-hannover.de
- Contact Person Name
- Bettina Wedi
- Contact Person Email
- wedi.bettina@mh-hannover.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 08-12-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 70
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Semmelweis University
- Department Name
- Internal medicine and Haematology
- Principal Investigator Name
- Henriette Farkas
- Principal Investigator Email
- farkas.henriette@semmelweis.hu
- Contact Person Name
- Henriette Farkas
- Contact Person Email
- farkas.henriette@semmelweis.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 29
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Policlinico San Donato S.p.A.
- Department Name
- Centro Angioedema
- Principal Investigator Name
- Andrea Zanichelli
- Principal Investigator Email
- andrea.zanichelli@unimi.it
- Contact Person Name
- Andrea Zanichelli
- Contact Person Email
- andrea.zanichelli@unimi.it
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- S.C.D.U. Immunologia e Allergologia
- Principal Investigator Name
- Luisa Brussino
- Principal Investigator Email
- luisa.brussino@unito.it
- Contact Person Name
- Luisa Brussino
- Contact Person Email
- luisa.brussino@unito.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- S.C. di Medicina Interna
- Principal Investigator Name
- Antonio Gidaro
- Principal Investigator Email
- gidaro.antonio@asst-fbf-sacco.it
- Contact Person Name
- Antonio Gidaro
- Contact Person Email
- gidaro.antonio@asst-fbf-sacco.it
- Site Name
- Istituti Clinici Scientifici Maugeri S.p.A.
- Department Name
- Ambulatorio di orticaria angioedema
- Principal Investigator Name
- Francesca Perego
- Principal Investigator Email
- francesca.perego@icsmaugeri.it
- Contact Person Name
- Francesca Perego
- Contact Person Email
- francesca.perego@icsmaugeri.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOSD di Allergologia
- Principal Investigator Name
- Riccardo Senter
- Principal Investigator Email
- riccardo.senter@aopd.veneto.it
- Contact Person Name
- Riccardo Senter
- Contact Person Email
- riccardo.senter@aopd.veneto.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- SC Medicina Interna - Departimento Scienze Mediche e Sanità Pubblica
- Principal Investigator Name
- Davide Firinu
- Principal Investigator Email
- davide.firinu@unica.it
- Contact Person Name
- Davide Firinu
- Contact Person Email
- davide.firinu@unica.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 18-12-2025
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 54
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Imunoalergologia
- Principal Investigator Name
- Frederico Regateiro
- Principal Investigator Email
- 10432@ulscoimbra.min-saude.pt
- Contact Person Name
- Frederico Regateiro
- Contact Person Email
- 10432@ulscoimbra.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Imunoalergologia
- Principal Investigator Name
- Manuel Ferreira
- Principal Investigator Email
- mbrancoferreira@gmail.com
- Contact Person Name
- Manuel Ferreira
- Contact Person Email
- mbrancoferreira@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 118
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Allergyc
- Principal Investigator Name
- Stefan Henning Cimbollek
- Principal Investigator Email
- stefan.henning.sspa@juntadeandalucia.es
- Contact Person Name
- Stefan Henning Cimbollek
- Contact Person Email
- stefan.henning.sspa@juntadeandalucia.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Allergyc
- Principal Investigator Name
- Bianca Andres Lopez
- Principal Investigator Email
- b.andres@bellvitgehospital.cat
- Contact Person Name
- Bianca Andres Lopez
- Contact Person Email
- b.andres@bellvitgehospital.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Allergyc
- Principal Investigator Name
- Leah Landaveri Sánchez
- Principal Investigator Email
- landaveri_lea@gva.es
- Contact Person Name
- Leah Landaveri Sánchez
- Contact Person Email
- landaveri_lea@gva.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Allergyc
- Principal Investigator Name
- Alicia Prieto Garcia
- Principal Investigator Email
- alicia.prieto@salud.madrid.org
- Contact Person Name
- Alicia Prieto Garcia
- Contact Person Email
- alicia.prieto@salud.madrid.org
- Site Name
- Hospital Universitario Nuestra Senora De Candelaria
- Department Name
- Allergyc
- Principal Investigator Name
- Ariel Callero
- Principal Investigator Email
- arielcallero@gmail.com
- Contact Person Name
- Ariel Callero
- Contact Person Email
- arielcallero@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 29-01-2026
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Vascular Medicine
- Principal Investigator Name
- Danny Cohn
- Principal Investigator Email
- d.m.cohn@amsterdamumc.nl
- Contact Person Name
- Danny Cohn
- Contact Person Email
- d.m.cohn@amsterdamumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 32
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Alergologii, Immunologii Klinicznej i Chorób Wewnętrznyc
- Principal Investigator Name
- Zbigniew Bartuzi
- Principal Investigator Email
- kikalerg@cm.umk.pl
- Contact Person Name
- Zbigniew Bartuzi
- Contact Person Email
- kikalerg@cm.umk.pl
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Klinika Chorób Wewnętrznych, Pneumonologii, Alergologii, Immunologii Klinicznej i Chorób Rzadkich
- Principal Investigator Name
- Aleksandra Kucharczyk
- Principal Investigator Email
- akucharczyk@wim.mil.pl
- Contact Person Name
- Aleksandra Kucharczyk
- Contact Person Email
- akucharczyk@wim.mil.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Centrum Alergologii-Poradnia Alergologiczna
- Principal Investigator Name
- Marcin Stobiecki
- Principal Investigator Email
- marcin.stobiecki@uj.edu.pl
- Contact Person Name
- Marcin Stobiecki
- Contact Person Email
- marcin.stobiecki@uj.edu.pl
- Site Name
- Umed Clinical Trials Sp. z o.o.
- Principal Investigator Name
- Marcin Kurowski
- Principal Investigator Email
- marcin.kurowski@umed.lodz.pl
- Contact Person Name
- Marcin Kurowski
- Contact Person Email
- marcin.kurowski@umed.lodz.pl
- Site Name
- Pawlukiewicz Małgorzata Prywatny Gabinet Lekarski
- Principal Investigator Name
- Malgorzata Pawlukiewicz
- Principal Investigator Email
- mpawlu@onet.eu
- Contact Person Name
- Malgorzata Pawlukiewicz
- Contact Person Email
- mpawlu@onet.eu
Sponsor
Primary sponsor
- Full Name
- Astria Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Medidata Solutions Inc.
- Responsibilities
- RTSM (Randomization and Trial Supply Management); sponsorDuties codes: 15,3,7
- Name
- Fortrea Inc.
- Responsibilities
- multiple operational roles including codes 1,13,15 (Ancillary supplies management),2,5,8
- Name
- Certara USA Inc.
- Responsibilities
- responsibility code 12
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- laboratory services (sponsorDuties code 4)
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- laboratory services (sponsorDuties code 4)
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"RTSM (Randomization and Trial Supply Management); codes: 15,3,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Certara USA Inc.","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"codes: 1,13,15 (Ancillary supplies management),2,5,8","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Navenibart
- Active Substance
- NAVENIBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Orphan Designation
- Yes
- Maximum Dose
- 600 mg (max daily amount as listed)
- Investigational Product Name
- Navenibart - matching placebo
- Modality
- Other
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