Clinical trial • Respiratory

ITEPEKIMAB for Chronic rhinosinusitis with nasal polyps

Clinical trial of ITEPEKIMAB for Chronic rhinosinusitis with nasal polyps.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Chronic rhinosinusitis with nasal polyps
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-01-2026
First CTIS Authorization Date
11-05-2026

Trial design

Randomised, matched placebo for test product (matched placebo for test product). dose/schedule: not specified-controlled trial in Belgium, Czechia, Denmark and others.

Randomised
Yes
Comparator
Matched placebo for test product (Matched placebo for test product). Dose/schedule: Not specified
Target Sample Size
234
Trial Duration For Participant
368

Eligibility

Recruits 234 Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is handled using subject information and informed consent forms (L1-redacted-sis-icf-main and country/language variants) and partner/pregnancy ICFs where applicable. Documents available in multiple languages (examples in the dossier: en, fr, nl, de, hu, it, pl, pt, ro, es, sv, cs, da, fi). Consent is provided by the participant; no paediatric assent processes are described in the provided materials..

Pregnancy Exclusion
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a women of childbearing potential (WOCBP), OR - Is a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is handled using subject information and informed consent forms (L1-redacted-sis-icf-main and country/language variants) and partner/pregnancy ICFs where applicable. Documents available in multiple languages (examples in the dossier: en, fr, nl, de, hu, it, pl, pt, ro, es, sv, cs, da, fi). Consent is provided by the participant; no paediatric assent processes are described in the provided materials.

Inclusion criteria

  • {"criterion_text":"- Participants with CRSwNP who completed the 52-weeks intervention period in a previous itepekimab CRSwNP Phase 3 clinical study (ie, EFC18418 or EFC18419) and for which an EOT visit occurred no later than 5 days before the enrollment visit of this study.\n- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a women of childbearing potential (WOCBP), OR - Is a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin.\n- Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status.\n- Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study.\n- Any other situation that led to a permanent premature IMP discontinuation in parent trials."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS\n- Change from baseline of the parent studies (EFC18418, EFC18419) in NCS\n- Functional itepekimab concentration in serum\n- Incidence of treatment-emergent anti-drug antibody (ADA) responses\n- Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS)\n- Annualized rate of SCS course or surgery for CRS","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
234
Recruitment Window Months
29
Consent Approach
Informed consent is obtained using subject information and informed consent forms (L1 redacted/main and country-language variants). Partner/pregnancy ICF documents are provided. Multiple language versions of ICFs are available for different countries. Consent is obtained from the participant (adult); no paediatric assent described.

Geography

Total Number Of Sites
77
Total Number Of Participants
130

Belgium

Earliest CTIS Part Ii Submission Date
07-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
35
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
UZ Leuven
Department Name
UZ Leuven Nose ear and throath
Principal Investigator Name
Peter Hellings
Principal Investigator Email
peter.hellings@uzleuven.be
Contact Person Name
Peter Hellings
Contact Person Email
peter.hellings@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
UZ Gent Nose ear and throath
Principal Investigator Name
Philippe Gevaert
Principal Investigator Email
philippe.gevaert@uzgent.be
Contact Person Name
Philippe Gevaert
Contact Person Email
philippe.gevaert@uzgent.be
Site Name
Pneumocare
Department Name
Pneumocare SPRL Pneumocare
Principal Investigator Name
Jean-Benoit Martinot
Principal Investigator Email
martinot.j@respisom.be
Contact Person Name
Jean-Benoit Martinot
Contact Person Email
martinot.j@respisom.be

Czechia

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
30
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Fakultní nemocnice v Motole
Principal Investigator Name
Stepan Novak
Principal Investigator Email
stepan.novak@fnmotol.cz
Contact Person Name
Stepan Novak
Contact Person Email
stepan.novak@fnmotol.cz
Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Nemocnice Pardubickeho kraje Pardubicka nemocnice
Principal Investigator Name
Zdenek Knizek
Principal Investigator Email
zdenek.knizek@nempk.cz
Contact Person Name
Zdenek Knizek
Contact Person Email
zdenek.knizek@nempk.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Fakultni nemocnice Hradec Kralove Fakultni Nemocnice HK
Principal Investigator Name
Viktor Chrobok
Principal Investigator Email
viktor.chrobok@fnhk.cz
Contact Person Name
Viktor Chrobok
Contact Person Email
viktor.chrobok@fnhk.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Fakultní nemocnice Královské Vinohrady Klinika ORL
Principal Investigator Name
Petr Schalek
Principal Investigator Email
petr.schalek@fnkv.cz
Contact Person Name
Petr Schalek
Contact Person Email
petr.schalek@fnkv.cz

Denmark

Earliest CTIS Part Ii Submission Date
17-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
24
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Region Sjaelland
Department Name
Øre-, Næse-, Halskirurgisk Afdeling/Dept of Otorhinolaryngology and Maxillofacial Surgery
Principal Investigator Name
Preben Homoe
Principal Investigator Email
prho@regionsjaelland.dk
Contact Person Name
Preben Homoe
Contact Person Email
prho@regionsjaelland.dk
Site Name
Region Midtjylland
Department Name
Department of Otorhinolaryngology, Head and Neck Surgery
Principal Investigator Name
Tejs Ehlers Klug
Principal Investigator Email
tejsklug@rm.dk
Contact Person Name
Tejs Ehlers Klug
Contact Person Email
tejsklug@rm.dk
Site Name
Rigshospitalet
Department Name
Rigshospitalet Afdeling for Øre, Næse-, Halskirurgi og Audiologi
Principal Investigator Name
Vibeke Backer
Principal Investigator Email
nina.vibeke.backer@regionh.dk
Contact Person Name
Vibeke Backer
Contact Person Email
nina.vibeke.backer@regionh.dk

Finland

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
31
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
HUS-yhtymae
Department Name
Ear, Nose and Throat Diseases
Principal Investigator Name
Marie Lundberg
Principal Investigator Email
marie.lundberg@hus.fi
Contact Person Name
Marie Lundberg
Contact Person Email
marie.lundberg@hus.fi
Site Name
Kuopio University Hospital
Department Name
Department of Otorhinolaryngology
Principal Investigator Name
Butoto Kazera
Principal Investigator Email
butoto.kazera@pshyvinvointialue.fi
Contact Person Name
Butoto Kazera
Site Name
HUS-yhtymae
Department Name
Inflammation Center, Allergy Dept
Principal Investigator Name
Annina Lyly
Principal Investigator Email
annina.lyly@hus.fi
Contact Person Name
Annina Lyly
Contact Person Email
annina.lyly@hus.fi

France

Earliest CTIS Part Ii Submission Date
07-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
34
Number Of Sites
7
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hôpital de la Conception Service ORL et de chirurgie cervico-faciale
Principal Investigator Name
Thomas Radulesco
Principal Investigator Email
thomas.radulesco@ap-hm.fr
Contact Person Name
Thomas Radulesco
Contact Person Email
thomas.radulesco@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
CHU Montpellier - Hopital Gui De Chauliac Département ORL-CCF-CMF et Stomatologie
Principal Investigator Name
Valentin Favier
Principal Investigator Email
v-favier@chu-montpellier.fr
Contact Person Name
Valentin Favier
Contact Person Email
v-favier@chu-montpellier.fr
Site Name
Hopital NOVO
Department Name
Hopital NOVO - Site de Pontoise
Principal Investigator Name
Khaled Al Tabaa
Principal Investigator Email
khaled.altabaa@ght-novo.fr
Contact Person Name
Khaled Al Tabaa
Contact Person Email
khaled.altabaa@ght-novo.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
ORL et chirurgie cervico-faciale
Principal Investigator Name
Florent Carsuzaa
Principal Investigator Email
florent.carsuzaa@chu-poitiers.fr
Contact Person Name
Florent Carsuzaa
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
CHU de Toulouse - Hôpital Larrey Service ORL
Principal Investigator Name
Guillaume De Bonnecaze
Principal Investigator Email
debonnecazelarrey31@gmail.com
Contact Person Name
Guillaume De Bonnecaze
Contact Person Email
debonnecazelarrey31@gmail.com
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
CHUdeN - L' Hopital l'hôtel-Dieu Service ORL et de chirurgie cervico-faciale
Principal Investigator Name
Olivier Malard
Principal Investigator Email
olivier.malard@chu-nantes.fr
Contact Person Name
Olivier Malard
Contact Person Email
olivier.malard@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
CHUdeB - Hopital Pellegrin Tripode service ORL, chirurgie cervico-faciale et d’ORL pédiatrique
Principal Investigator Name
Ludovic de Gabory
Principal Investigator Email
ludovic.de-gabory@chu-bordeaux.fr
Contact Person Name
Ludovic de Gabory

Germany

Earliest CTIS Part Ii Submission Date
14-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
28
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Technische Universitaet Dresden
Department Name
Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für HNO-Heilkunde
Principal Investigator Name
Philipp Nahrath
Principal Investigator Email
philipp.nahrath@ukdd.de
Contact Person Name
Philipp Nahrath
Contact Person Email
philipp.nahrath@ukdd.de
Site Name
Universitaet Muenster
Department Name
Universitätsklinikum Münster - Albert Schweitzer Campus Klinik für Hals-, Nasen und Ohrenheilkunde
Principal Investigator Name
Claudia Rudack
Principal Investigator Email
rudackc@ukmuenster.de
Contact Person Name
Claudia Rudack
Contact Person Email
rudackc@ukmuenster.de
Site Name
GEKA Gesellschaft fuer Experimentelle und Klinische Atemwegsforschung mbH
Department Name
Zentrum für Rhinologie und Allergologie
Principal Investigator Name
Jan Hagemann
Principal Investigator Email
jan.hagemann@allergiezentrum.org
Contact Person Name
Jan Hagemann
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Universitätsklinikum Würzburg Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde
Principal Investigator Name
Pascal Ickrath
Principal Investigator Email
ickrath_p@ukw.de
Contact Person Name
Pascal Ickrath
Contact Person Email
ickrath_p@ukw.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Charité Universitätsmedizin Berlin - Campus Mitte
Principal Investigator Name
Heidi Olze
Principal Investigator Email
Heidi.olze@charite.de
Contact Person Name
Heidi Olze
Contact Person Email
Heidi.olze@charite.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitätsklinikum Tübingen Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Principal Investigator Name
Sven Becker
Principal Investigator Email
Sven.Becker@med.uni-tuebingen.de
Contact Person Name
Sven Becker
Site Name
Universitaet Leipzig
Department Name
UL Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde/Plastische Operationen
Principal Investigator Name
Andreas Dietz
Principal Investigator Email
andreas.dietz@medizin.uni-leipzig.de
Contact Person Name
Andreas Dietz

Hungary

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
63
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Rhinoto Kft.
Department Name
Rhinoto Clinical research
Principal Investigator Name
Laszlo Lujber
Principal Investigator Email
lujber@yahoo.com
Contact Person Name
Laszlo Lujber
Contact Person Email
lujber@yahoo.com
Site Name
RMC Medical Zrt.
Department Name
RMC Medical - Budapest Clinical research
Principal Investigator Name
Laszlo Balogh
Principal Investigator Email
balogh.crs@gmail.com
Contact Person Name
Laszlo Balogh
Contact Person Email
balogh.crs@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Jósa András Oktatókórház Ful- Orr- Gegeszet es Fej- Nyaksebeszeti Osztaly
Principal Investigator Name
Judit Bakk
Principal Investigator Email
bakkjudit@gmail.com
Contact Person Name
Judit Bakk
Contact Person Email
bakkjudit@gmail.com
Site Name
University Of Szeged
Department Name
Szegedi Tudományegyetem Fül-Orr-Gégészeti és Fej-Nyaksebészeti Klinika
Principal Investigator Name
Agnes Kiricsi
Principal Investigator Email
akiricsi78@gmail.com
Contact Person Name
Agnes Kiricsi
Contact Person Email
akiricsi78@gmail.com
Site Name
University Of Debrecen
Department Name
Debreceni Egyetem Fül-Orr-Gégészeti és Fej-Nyaksebészeti Klinika
Principal Investigator Name
Balazs Sztano
Principal Investigator Email
sztano.balazs@med.unideb.hu
Contact Person Name
Balazs Sztano
Contact Person Email
sztano.balazs@med.unideb.hu
Site Name
Ujpesti Egeszsegkoezpont
Department Name
Ujpesti Egeszsegkoezpont Ful-Orr-Gegeszeti Szakrendeles
Principal Investigator Name
Zsuzsanna Horvath
Principal Investigator Email
thorvathzs@gmail.com
Contact Person Name
Zsuzsanna Horvath
Contact Person Email
thorvathzs@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
07-04-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
37
Number Of Sites
9
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Azienda Ospedaliera Universitaria Federico II U.O.C Otorinolaringoiatria
Principal Investigator Name
Aikaterini Detoraki
Principal Investigator Email
aikaterini.detoraki@unina.it
Contact Person Name
Aikaterini Detoraki
Contact Person Email
aikaterini.detoraki@unina.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Azienda - Ospedale Università di Padova U.O.C. otorinolaringoiatria
Principal Investigator Name
Giancarlo Ottaviano
Principal Investigator Email
giancarlo.ottaviano@unipd.it
Contact Person Name
Giancarlo Ottaviano
Contact Person Email
giancarlo.ottaviano@unipd.it
Site Name
Instituto Di Ricovero E Cura A Carattere Scientifico
Department Name
Ospedale Bellaria U.O.C. Otorinolaringoiatria
Principal Investigator Name
Ernesto Pasquini
Principal Investigator Email
ernesto.pasquini@ausl.bologna.it
Contact Person Name
Ernesto Pasquini
Site Name
Ospedale San Raffaele S.r.l.
Department Name
IRCCS Ospedale San Raffaele U.O. Otorinolaringoiatria
Principal Investigator Name
Giulia Dane
Principal Investigator Email
dane.giulia@hsr.it
Contact Person Name
Giulia Dane
Contact Person Email
dane.giulia@hsr.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
AOUP Gaspare Rodolico - San Marco (Presidio G. Rodolico) Dipartimento di Otorinolaringoiatria
Principal Investigator Name
Giovanna Stilo
Principal Investigator Email
giovastilo@gmail.com
Contact Person Name
Giovanna Stilo
Contact Person Email
giovastilo@gmail.com
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Azienda Ospedaliero - Universitaria Careggi SOD Immunoallergologia
Principal Investigator Name
Alessandra Vultaggio
Principal Investigator Email
alessandra.vultaggio@unifi.it
Contact Person Name
Alessandra Vultaggio
Contact Person Email
alessandra.vultaggio@unifi.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
IRCCS Ospedale Policlinico San Martino U.O.C. Otorinolaringoiatria-DISC
Principal Investigator Name
Frank Canevari
Principal Investigator Email
frank.canevari@unige.it
Contact Person Name
Frank Canevari
Contact Person Email
frank.canevari@unige.it
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
ASST Santi Paolo e Carlo S.C. Otorinolaringologia
Principal Investigator Name
Carlotta Pipolo
Principal Investigator Email
carlotta.pipolo@unimi.it
Contact Person Name
Carlotta Pipolo
Contact Person Email
carlotta.pipolo@unimi.it
Site Name
University Hospital Of Ferrara
Department Name
AOUdiF - Ospedale Sant'Anna Dipartimento Testa collo (1B2) - U.O.C. Otorinolaringoiatria
Principal Investigator Name
Stefano Pelucchi
Principal Investigator Email
stefano.pelucchi@unife.it
Contact Person Name
Stefano Pelucchi
Contact Person Email
stefano.pelucchi@unife.it

Portugal

Earliest CTIS Part Ii Submission Date
31-03-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
42
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Department Name
Unidade Local de Saude de Entre Douro e Vouga - Hospital de Sao Sebastiao
Principal Investigator Name
Tiago Santos
Principal Investigator Email
tiago.santos@ulsedv.min-saude.pt
Contact Person Name
Tiago Santos
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Unidade Local de Saúde de Matosinhos, E.P.E., Hospital Pedro Hispano
Principal Investigator Name
Jose-Alberto Ferreira
Principal Investigator Email
jose.ferreirapeneda@ulsm.min-saude.pt
Contact Person Name
Jose-Alberto Ferreira
Site Name
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Department Name
Unidade Local de Saúde Regional de Aveiro EPE
Principal Investigator Name
Maria Azevedo
Principal Investigator Email
Maria.Azevedo.11348@ulsra.min-saude.pt
Contact Person Name
Maria Azevedo
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Hospital da Senhora da Oliveira, Guimarães
Principal Investigator Name
Francisco Moreira da Silva
Principal Investigator Email
fmoreiradasilva@gmail.com
Contact Person Name
Francisco Moreira da Silva
Contact Person Email
fmoreiradasilva@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
31
Number Of Sites
15
Number Of Participants
22

Sites

Site Name
Hospital De Jerez De La Frontera
Department Name
Hospital Jerez de la Frontera Hospital General de Jerez (#1)
Principal Investigator Name
Alfonso Del Cuvillo Bernal
Principal Investigator Email
dr.cuvillo@gmail.com
Contact Person Name
Alfonso Del Cuvillo Bernal
Contact Person Email
dr.cuvillo@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Hospital Clínic de Barcelona Hospital Clinic i Provincial (#1)
Principal Investigator Name
Joaquim Mullol Miret
Principal Investigator Email
jmullol@clinic.cat
Contact Person Name
Joaquim Mullol Miret
Contact Person Email
jmullol@clinic.cat
Site Name
Bellvitge University Hospital
Department Name
Hospital Universitari de Bellvitge
Principal Investigator Name
Xavier Gonzalez-Compta
Principal Investigator Email
xgonzalez@bellvitgehospital.cat
Contact Person Name
Xavier Gonzalez-Compta
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Hospital Clínico Universitario de Santiago de Compostela
Principal Investigator Name
Gabriel Adolfo Martinez Capoccioni
Contact Person Name
Gabriel Adolfo Martinez Capoccioni
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hospital Universitario Puerta de Hierro Majadahonda
Principal Investigator Name
Maria Teresa Pinilla Urraca
Principal Investigator Email
pinillamayte@gmail.com
Contact Person Name
Maria Teresa Pinilla Urraca
Contact Person Email
pinillamayte@gmail.com
Site Name
Hospital Del Mar
Department Name
Parc de Salut Mar - Hospital del Mar
Principal Investigator Name
Rafael Hijano Esque
Principal Investigator Email
rhijano@psmar.cat
Contact Person Name
Rafael Hijano Esque
Contact Person Email
rhijano@psmar.cat
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Hospital Clínico Universitario Lozano Blesa Hospital Clínico Lozano Blesa (#1)
Principal Investigator Name
Jose-Ignacio Alfonso-Collado
Principal Investigator Email
tachoalfonso@gmail.com
Contact Person Name
Jose-Ignacio Alfonso-Collado
Contact Person Email
tachoalfonso@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Hospital Universitario Virgen Macarena
Principal Investigator Name
Serafín Sánchez Gómez
Principal Investigator Email
serafin.sanchez.sspa@juntadeandalucia.es
Contact Person Name
Serafín Sánchez Gómez
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hospital Universitario Marqués de Valdecilla Hospital Universitario Marques De Valdecilla (#1)
Principal Investigator Name
David Robinson Lobo Duro
Principal Investigator Email
david.lobo@scsalud.es
Contact Person Name
David Robinson Lobo Duro
Contact Person Email
david.lobo@scsalud.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hospital Universitario Fundación Jiménez Díaz
Principal Investigator Name
Jose Miguel Villacampa Auba
Principal Investigator Email
JMVillacampa@fjd.es
Contact Person Name
Jose Miguel Villacampa Auba
Contact Person Email
JMVillacampa@fjd.es
Site Name
Clinica Universidad De Navarra
Department Name
Clinica Universidad de Navarra - Pamplona
Principal Investigator Name
Secundino Fernandez
Principal Investigator Email
sfgonzalez@unav.es
Contact Person Name
Secundino Fernandez
Contact Person Email
sfgonzalez@unav.es
Site Name
Centro Medico Teknon-Grupo Quironsalud
Department Name
Centro Médico Teknon
Principal Investigator Name
Isam Alobid
Principal Investigator Email
isamalobid@gmail.com
Contact Person Name
Isam Alobid
Contact Person Email
isamalobid@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hospital Universitario Ramón y Cajal
Principal Investigator Name
Alfonso Santamaria Gadea
Principal Investigator Email
asantamariagadea@gmail.com
Contact Person Name
Alfonso Santamaria Gadea
Contact Person Email
asantamariagadea@gmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Hospital Universitari Parc Tauli
Principal Investigator Name
Alda Cardesin-Revilla
Principal Investigator Email
acardesin@tauli.cat
Contact Person Name
Alda Cardesin-Revilla
Contact Person Email
acardesin@tauli.cat
Site Name
Clinica Gaias Santiago
Department Name
Clínica Gaias - Santiago
Principal Investigator Name
Joaquín Guerra Gómez
Principal Investigator Email
joaquinguerraensayos@hotmail.com
Contact Person Name
Joaquín Guerra Gómez

Sweden

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
28
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Oeronkliniken Stockholm AB
Department Name
Sophiahemmet Öron-näs-halskliniken
Principal Investigator Name
Mattias Jangard
Principal Investigator Email
mattias.jangard@oronkliniken.se
Contact Person Name
Mattias Jangard
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Skånes Universitetssjukhus Öron-, näs- och halskliniken
Principal Investigator Name
Cecilia Ahlstrom-Emanuelsson
Principal Investigator Email
cecilia.ahlstrom-emanuelsson@skane.se
Contact Person Name
Cecilia Ahlstrom-Emanuelsson
Site Name
Karolinska University Hospital
Department Name
Karolinska Universitetssjukhuset Solna Öron, Näs och halsmottagningen
Principal Investigator Name
Lars Olaf Cardell
Principal Investigator Email
lars-olaf.cardell@ki.se
Contact Person Name
Lars Olaf Cardell
Contact Person Email
lars-olaf.cardell@ki.se

Netherlands

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
30
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Noordwest Ziekenhuisgroep, locatie Alkmaar Otorhinolaryngology
Principal Investigator Name
Lisa van der Putten
Principal Investigator Email
l.vander.putten@nwz.nl
Contact Person Name
Lisa van der Putten
Contact Person Email
l.vander.putten@nwz.nl
Site Name
Amsterdam UMC Stichting
Department Name
Amsterdam UMC, locatie VUMC
Principal Investigator Name
Sietze Reitsma
Principal Investigator Email
s.reitsma@amsterdamumc.nl
Contact Person Name
Sietze Reitsma
Contact Person Email
s.reitsma@amsterdamumc.nl
Site Name
Alrijne Zorggroep Stichting
Department Name
Alrijne Ziekenhuis, locatie Leiderdorp Otorhinolaryngology
Principal Investigator Name
Marjolein Cornet
Principal Investigator Email
mecornet@alrijne.nl
Contact Person Name
Marjolein Cornet
Contact Person Email
mecornet@alrijne.nl

Poland

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
35
Number Of Sites
10
Number Of Participants
14

Sites

Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
CSzKWAMK Otolaryngologii i Onkologii Laryngologicznej z Klinicznym Oddzialem Chirurgii Cz-Sz-T
Principal Investigator Name
Dariusz Jurkiewicz
Principal Investigator Email
djurkiewicz@wim.mil.pl
Contact Person Name
Dariusz Jurkiewicz
Contact Person Email
djurkiewicz@wim.mil.pl
Site Name
Szpital Swietego Lukasza S.A.
Department Name
Szpital Sw.Lukasza
Principal Investigator Name
Sarka Solecka
Principal Investigator Email
sarkasolecka@gmail.com
Contact Person Name
Sarka Solecka
Contact Person Email
sarkasolecka@gmail.com
Site Name
Vistamed & Vertigo Sp. z o.o.
Department Name
Vistamed & Vertigo
Principal Investigator Name
Katarzyna Bitowska
Principal Investigator Email
k.bitowska@vistamed.pl
Contact Person Name
Katarzyna Bitowska
Contact Person Email
k.bitowska@vistamed.pl
Site Name
Dobrostan Gabinet Lekarskie
Department Name
Dobrostan Gabinet Lekarskie
Principal Investigator Name
Ewa Pisarczyk-Bogacka
Principal Investigator Email
bogacka@alergia.gigabox.pl
Contact Person Name
Ewa Pisarczyk-Bogacka
Contact Person Email
bogacka@alergia.gigabox.pl
Site Name
Pracownia Badań Klinicznych Salus
Department Name
Pracownia Badań Klinicznych Salus
Principal Investigator Name
Pawel Golach
Principal Investigator Email
pawel.golach@pbks.com.pl
Contact Person Name
Pawel Golach
Contact Person Email
pawel.golach@pbks.com.pl
Site Name
Promed P.Lach R.Glowacki Sp. j.
Department Name
Centrum Medyczne PROMED - Olszanska Centrum Medyczne PROMED
Principal Investigator Name
Anita Adamska-Malicka
Principal Investigator Email
a.adamska@cmpromed.pl
Contact Person Name
Anita Adamska-Malicka
Contact Person Email
a.adamska@cmpromed.pl
Site Name
Santa Sp. z o.o.
Department Name
Santa Familia PTG Łódź
Principal Investigator Name
Magdalena Jozefowicz-Korczynska
Contact Person Name
Magdalena Jozefowicz-Korczynska
Site Name
Velocity Nova Sp. z o.o.
Department Name
Velocity Clinical Research - Lublin
Principal Investigator Name
Tomasz Broda
Principal Investigator Email
tbroda@velocityclinical.com
Contact Person Name
Tomasz Broda
Contact Person Email
tbroda@velocityclinical.com
Site Name
Revit Sp. z o.o.
Department Name
Centrum Zdrowia Psychicznego Revit
Principal Investigator Name
Piotr Lupinski
Principal Investigator Email
cmswobodna@gmail.com
Contact Person Name
Piotr Lupinski
Contact Person Email
cmswobodna@gmail.com
Site Name
Alergologia Plus Sp. z o.o.
Department Name
Alergologia Plus Sp. zo.o Osrodek Diagnostyki i Terapii
Principal Investigator Name
Michal Springer
Principal Investigator Email
michal.springer.pl@gmail.com
Contact Person Name
Michal Springer
Contact Person Email
michal.springer.pl@gmail.com

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Suvoda LLC
Responsibilities
[{"code":"3"}]
Name
Eresearchtechnology Inc.
Responsibilities
[{"code":"7"}]
Name
Bioclinica Inc.
Responsibilities
[{"code":"15","value":"Imaging"}]
Name
Medidata Solutions Inc.
Responsibilities
[{"code":"7"}]
Name
Azenta Germany GmbH
Responsibilities
[{"code":"4"}]
Name
Azenta US Inc.
Responsibilities
[{"code":"4"}]

Third parties

  • {"country":"Italy","full_name":"Assinde SRL","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[{\"code\":\"3\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Regeneron Pharmaceuticals Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Centralized 24-Hour Emergency System\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"[{\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Imaging\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Itepekimab
Active Substance
ITEPEKIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Investigational Product Name
Matched placebo for test product
Modality
Other

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