Clinical trial • Phase III • Respiratory
ITEPEKIMAB for Chronic rhinosinusitis with nasal polyps
Phase III trial of ITEPEKIMAB for Chronic rhinosinusitis with nasal polyps.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Chronic rhinosinusitis with nasal polyps
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-11-2024
- First CTIS Authorization Date
- 31-03-2025
Trial design
Randomised, matched placebo for test product (placebo). no active comparator; dose/schedule for placebo not specified in available documents.-controlled Phase III trial across 51 sites in Sweden, Austria, Finland and others.
- Randomised
- Yes
- Comparator
- Matched placebo for test product (placebo). No active comparator; dose/schedule for placebo not specified in available documents.
- Target Sample Size
- 251
- Trial Duration For Participant
- 364
Eligibility
Recruits 251 isVulnerablePopulationSelected = true. Subject information and informed consent forms are provided (L1-redacted SIS-ICF main patient and partner/pregnancy forms and other L2 materials are listed in the trial documents). Participants must be 18 years or older, so consent is provided by the participant; partner/pregnancy-specific ICF materials are available. No separate assent procedures for minors are applicable because minimum age is 18..
- Pregnancy Exclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: o Is not a women of childbearing potential (WOCBP), OR o Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study (at a minimum until 20 weeks after the last dose of study intervention).
- Vulnerable Population
- isVulnerablePopulationSelected = true. Subject information and informed consent forms are provided (L1-redacted SIS-ICF main patient and partner/pregnancy forms and other L2 materials are listed in the trial documents). Participants must be 18 years or older, so consent is provided by the participant; partner/pregnancy-specific ICF materials are available. No separate assent procedures for minors are applicable because minimum age is 18.
Inclusion criteria
- {"criterion_text":"- Participants must be 18 years of age or older\n- Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening\n- Participants must have at least one of the following features: o\tPrior sinonasal surgery for nasal polyps (NP). o\tWorsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 years before screening (Visit 1).\n- An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization.\n- Ongoing symptoms (for at least 12 weeks before Visit 1) of: o\tNasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND o\tAt least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).\n- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: o\tIs not a women of childbearing potential (WOCBP), OR o\tIs a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study (at a minimum until 20 weeks after the last dose of study intervention)."}
Exclusion criteria
- {"criterion_text":"- Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease (AERD) which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.\n- Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.\n- Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).\n- Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study.\n- Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred <6 months prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco.\n- Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections.\n- Participants with a history of a severe systemic hypersensitivity reaction to a mAb.\n- Participants with conditions/concomitant diseases making them nonevaluable at Visit 1 or for the primary efficacy endpoint.\n- Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc).\n- Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.\n- History of concomitant lung disease (other than asthma, eg, COPD, interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry.\n- Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in the endoscopic NPS","definition_or_measurement_approach":"Change from baseline in the endoscopic Nasal Polyp Score (NPS) assessed endoscopically."}
- {"endpoint_text":"- Change from baseline in the NCS","definition_or_measurement_approach":"Change from baseline in the Nasal Congestion Score (NCS)."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in endoscopic NPS","definition_or_measurement_approach":"Change from baseline in endoscopic Nasal Polyp Score (NPS)."}
- {"endpoint_text":"- Change from baseline in NCS","definition_or_measurement_approach":"Change from baseline in Nasal Congestion Score (NCS)."}
- {"endpoint_text":"- Change from baseline in opacification of sinuses assessed by Computed Tomography (CT) scan using the LMK score","definition_or_measurement_approach":"Change from baseline in sinus opacification assessed by CT scan using the LMK score."}
- {"endpoint_text":"- Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)","definition_or_measurement_approach":"Change from baseline in Total Symptom Score (TSS) covering nasal congestion/obstruction, rhinorrhea and loss of smell."}
- {"endpoint_text":"- Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary, and UPSIT score","definition_or_measurement_approach":"Change from baseline in loss of smell severity per daily CRSwNP sinonasal symptom eDiary and University of Pennsylvania Smell Identification Test (UPSIT) score."}
- {"endpoint_text":"- Change from baseline in SNOT22 total score","definition_or_measurement_approach":"Change from baseline in the Sino-Nasal Outcome Test (SNOT-22) total score."}
- {"endpoint_text":"- Change from baseline in PROMIS SDSF8b scores","definition_or_measurement_approach":"Change from baseline in PROMIS Sleep Disturbance short form (SD-SF-8b) scores."}
- {"endpoint_text":"- Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for CRS","definition_or_measurement_approach":"Proportion of participants with CRSwNP who require systemic corticosteroids or sinus surgery for CRS."}
- {"endpoint_text":"- Annualized rate of SCS course or surgery for CRS","definition_or_measurement_approach":"Annualized rate of courses of systemic corticosteroids or surgeries for CRS."}
- {"endpoint_text":"- Time to first either SCS or surgery for CRS","definition_or_measurement_approach":"Time-to-event: time to first systemic corticosteroid course or sinus surgery for CRS."}
- {"endpoint_text":"- Change from baseline in pre BD FEV1 (in mL) in participants with co-morbid asthma","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 (mL) in participants with comorbid asthma."}
- {"endpoint_text":"- Change from baseline in ACQ 5 score in participants with co-morbid asthma","definition_or_measurement_approach":"Change from baseline in Asthma Control Questionnaire (ACQ-5) score in participants with comorbid asthma."}
- {"endpoint_text":"- Change from the baseline in NPS and NCS in the subgroup of patients with aspirin-exacerbated respiratory disease (AERD)","definition_or_measurement_approach":"Change from baseline in NPS and NCS in the AERD subgroup."}
- {"endpoint_text":"- Proportion of participants with AERD requiring SCS or surgery for CRS","definition_or_measurement_approach":"Proportion of AERD participants requiring systemic corticosteroids or surgery for CRS."}
- {"endpoint_text":"- Annualized rate of SCS course or surgery for CRS in participants with AERD","definition_or_measurement_approach":"Annualized rate of SCS course or surgery for CRS in AERD participants."}
- {"endpoint_text":"- Time to first either SCS or surgery for CRS in participants with AERD","definition_or_measurement_approach":"Time to first SCS course or surgery for CRS in AERD subgroup."}
- {"endpoint_text":"- Change from baseline in pre BD FEV1 (in ml) in participants with AERD","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 (mL) in AERD participants."}
- {"endpoint_text":"- Proportion of NPS responders (defined as participants with improvement by at least 1 point in NPS)","definition_or_measurement_approach":"Proportion of participants achieving ≥1-point improvement in NPS."}
- {"endpoint_text":"- Proportion of NPS responders (defined as participants with improvement by at least 2 points in NPS)","definition_or_measurement_approach":"Proportion of participants achieving ≥2-point improvement in NPS."}
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events of special interest (TEAESIs) and TEAEs leading to treatment discontinuation","definition_or_measurement_approach":"Incidence and characterization of TEAEs, TESAEs, TEAESIs and TEAEs leading to discontinuation."}
- {"endpoint_text":"- Itepekimab concentration in serum","definition_or_measurement_approach":"Measurement of itepekimab serum concentrations (pharmacokinetics)."}
- {"endpoint_text":"- Incidence of treatment emergent anti itepekimab antibody (ADA) responses","definition_or_measurement_approach":"Incidence of treatment-emergent anti-itepekimab antibody responses (immunogenicity)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 251
- Recruitment Window Months
- 32
- Consent Approach
- Informed consent is obtained using subject information and ICF documents (L1-redacted SIS-ICF main patient forms and partner/pregnancy forms are included among documents). Participant age minimum is 18 years, so consent is provided by the participant. ICFs are available in multiple languages (documents list includes English, Swedish, German, Hungarian, Polish, Italian, Portuguese, Spanish, Finnish, Dutch). Partner/pregnancy-specific information forms are provided where relevant.
Methods
- PI-to-patient letters (country-specific K2 and K1 recruitment materials listed, e.g., 'pi-to-patient-letter' PDFs in multiple languages) — channel: direct site/PI communication to potential participants; target audience: patients with CRSwNP; country-specific materials present (sv, de, fi, it, nl, pl, pt, es, etc.).
- Doctor-to-doctor letters (country-specific K2 materials) — channel: clinician/GP outreach to refer eligible patients; target audience: treating physicians/ENT specialists; country-specific versions present.
- Posters and flyers (K2 recruitment-material-poster/flyer per country) — channel: printed/site display; target audience: clinic patients and public; country-specific versions present.
- Social media posts and digital marketing content (K2-recruitment-material-social-media-post-*, digital-marketing-content-*) — channel: social media and online advertising; target audience: patients with CRSwNP and the general public; country-specific versions available.
- Landing pages and self-assessment tools (K2-recruitment-material-landing-page-*, self-assessment-*) — channel: web-based landing pages and online self-assessment questionnaires to pre-screen interest; target audience: potential participants; country-specific versions available.
- Placebo informational videoscripts and placebo factsheets (K2 recruitment materials) — channel: multimedia patient-facing information to support recruitment and informed choice.
- Patient diaries and patient-facing materials (protocol-related D4 documents) are included as part of patient information.
Geography
- Total Number Of Sites
- 51
- Total Number Of Participants
- 131
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 158
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Öron-, näs- och halskliniken
- Principal Investigator Name
- Cecilia Ahlstrom Emanuelsson
- Principal Investigator Email
- cecilia.ahlstrom-emanuelsson@skane.se
- Contact Person Name
- Cecilia Ahlstrom Emanuelsson
- Contact Person Email
- cecilia.ahlstrom-emanuelsson@skane.se
- Site Name
- Oeronkliniken Stockholm AB
- Department Name
- Huvud- och halssjukdomar
- Principal Investigator Name
- Mattias Jangard
- Principal Investigator Email
- mattias.jangard@oronkliniken.se
- Contact Person Name
- Mattias Jangard
- Contact Person Email
- mattias.jangard@oronkliniken.se
- Site Name
- Karolinska University Hospital
- Department Name
- 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
Austria
- Earliest CTIS Part Ii Submission Date
- 26-03-2025
- Latest Decision Or Authorization Date
- 21-07-2025
- Processing Time Days
- 117
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde und Hör-, Stimm- und Sprachstörungen
- Principal Investigator Name
- Ljilja Bektic-Tadic
- Principal Investigator Email
- l.bektic-tadic@tirol-kliniken.at
- Contact Person Name
- Ljilja Bektic-Tadic
- Contact Person Email
- l.bektic-tadic@tirol-kliniken.at
- Site Name
- Medical University of Vienna
- Department Name
- Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
- Principal Investigator Name
- Sven Schneider
- Principal Investigator Email
- sven.schneider@meduniwien.ac.at
- Contact Person Name
- Sven Schneider
- Contact Person Email
- sven.schneider@meduniwien.ac.at
- Site Name
- University Hospital Graz
- Department Name
- Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
- Principal Investigator Name
- Alexandros Andrianakis
- Principal Investigator Email
- alexandros.andrianakis@medunigraz.at
- Contact Person Name
- Alexandros Andrianakis
- Contact Person Email
- alexandros.andrianakis@medunigraz.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- HNO, Kopf- und Halschirurgie
- Principal Investigator Name
- Martin Bruch
- Principal Investigator Email
- Martin.Bruch@ordensklinikum.at
- Contact Person Name
- Martin Bruch
- Contact Person Email
- Martin.Bruch@ordensklinikum.at
- Site Name
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
- Department Name
- Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
- Principal Investigator Name
- Gerd RASP
- Principal Investigator Email
- g.rasp@salk.at
- Contact Person Name
- Gerd RASP
- Contact Person Email
- g.rasp@salk.at
Finland
- Earliest CTIS Part Ii Submission Date
- 03-03-2025
- Latest Decision Or Authorization Date
- 31-07-2025
- Processing Time Days
- 150
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- 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
- Contact Person Email
- butoto.kazera@pshyvinvointialue.fi
- 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
- 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
- Site Name
- Tampere University Hospital
- Department Name
- Korva-, nena- ja kurkkutautien poliklinikka
- Principal Investigator Name
- Sillanpää Saara
- Principal Investigator Email
- saara.sillanpaa@pirha.fi
- Contact Person Name
- Sillanpää Saara
- Contact Person Email
- saara.sillanpaa@pirha.fi
Hungary
- Earliest CTIS Part Ii Submission Date
- 26-03-2025
- Latest Decision Or Authorization Date
- 13-08-2025
- Processing Time Days
- 140
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- 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
- Ujpesti Egeszsegugyi Nonprofit Kft.
- Department Name
- 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
- Site Name
- Rhinoto Kft.
- Principal Investigator Name
- Laszlo Lujber
- Principal Investigator Email
- lujber@yahoo.com
- Contact Person Name
- Laszlo Lujber
- Contact Person Email
- lujber@yahoo.com
- Site Name
- University Of Debrecen
- Department Name
- 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
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-03-2025
- Latest Decision Or Authorization Date
- 30-07-2025
- Processing Time Days
- 127
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- 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
- Alrijne Zorggroep Stichting
- Department Name
- 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
- 26-03-2025
- Latest Decision Or Authorization Date
- 18-07-2025
- Processing Time Days
- 114
- Number Of Sites
- 7
- Number Of Participants
- 13
Sites
- Site Name
- Revit Sp. z o.o.
- Principal Investigator Name
- Piotr Lupinski
- Principal Investigator Email
- cmswobodna@gmail.com
- Contact Person Name
- Piotr Lupinski
- Contact Person Email
- cmswobodna@gmail.com
- Site Name
- Promed P.Lach R.Glowacki Sp. j.
- Principal Investigator Name
- Anita Adamska-Malicka
- Principal Investigator Email
- anitaa09@tlen.pl
- Contact Person Name
- Anita Adamska-Malicka
- Contact Person Email
- anitaa09@tlen.pl
- Site Name
- Vistamed & Vertigo Sp. z o.o.
- Principal Investigator Name
- Katarzyna Barbara Bitowska
- Principal Investigator Email
- k.bitowska@vistamed.pl
- Contact Person Name
- Katarzyna Barbara Bitowska
- Contact Person Email
- k.bitowska@vistamed.pl
- Site Name
- Velocity Nova Sp. z o.o.
- Principal Investigator Name
- Tomasz Broda
- Principal Investigator Email
- tbroda@velocityclinical.com
- Contact Person Name
- Tomasz Broda
- Contact Person Email
- tbroda@velocityclinical.com
- Site Name
- Michal Bogacki - Dobrostan
- 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
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Klinika Otolaryngologii i Onkologii Laryngologicznej z Klinicznym Oddziałem Chirurgii Czaszkowo-Szc
- Principal Investigator Name
- Dariusz Janusz Jurkiewicz
- Principal Investigator Email
- djurkiewicz@wim.mil.pl
- Contact Person Name
- Dariusz Janusz Jurkiewicz
- Contact Person Email
- djurkiewicz@wim.mil.pl
- Site Name
- Ul. Swobodna 38 (site contact)
- Contact Person Name
- Piotr Lupinski
- Contact Person Email
- cmswobodna@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 07-03-2025
- Latest Decision Or Authorization Date
- 24-10-2025
- Processing Time Days
- 231
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- otorhinolaryngology department
- Principal Investigator Name
- Alfonso del Cuvillo Bernal
- Principal Investigator Email
- dr.cuvillo@comcadiz.es
- Contact Person Name
- Alfonso del Cuvillo Bernal
- Contact Person Email
- dr.cuvillo@comcadiz.es
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- otorhinolaryngology department
- Principal Investigator Name
- JOSE IGNACIO ALFONSO COLLADO
- Principal Investigator Email
- jalfonso@salud.aragon.es
- Contact Person Name
- JOSE IGNACIO S ven Schneider
- Contact Person Email
- jalfonso@salud.aragon.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- otorhinolaryngology department
- Principal Investigator Name
- Serafin Sanchez Gomez
- Principal Investigator Email
- serafin.sanchez.sspa@juntadeandalucia.es
- Contact Person Name
- Serafin Sanchez Gomez
- Contact Person Email
- serafin.sanchez.sspa@juntadeandalucia.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- otorhinolaryngology department
- Principal Investigator Name
- Gabriel Martínez-Capoccioni
- Principal Investigator Email
- gabrielmartinez82@hotmail.com
- Contact Person Name
- Gabriel Martínez-Capoccioni
- Contact Person Email
- gabrielmartinez82@hotmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- otorhinolaryngology department
- 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 Clinic De Barcelona
- Department Name
- otorhinolaryngology department
- Principal Investigator Name
- JOAQUIM MULLLOL MIRET
- Principal Investigator Email
- jmullol@clinic.cat
- Contact Person Name
- JOAQUIM MULLLOL MIRET
- Contact Person Email
- jmullol@clinic.cat
- Site Name
- Hospital Universitario Virgen De La Macarena (additional contact)
- Department Name
- otorhinolaryngology department
- Contact Person Name
- Serafin Sanchez Gomez
- Contact Person Email
- serafin.sanchez.sspa@juntadeandalucia.es
Portugal
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 271
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
- Department Name
- Otorhinolaryngology service
- Principal Investigator Name
- Tiago SOARES Santos
- Principal Investigator Email
- tiago.santos@ulsedv.min-saude.pt
- Contact Person Name
- Tiago SOARES Santos
- Contact Person Email
- tiago.santos@ulsedv.min-saude.pt
- Site Name
- Hospital Pedro Hispano
- Department Name
- Otorhinolaryngology service
- Principal Investigator Name
- José Ferreira Peneda
- Principal Investigator Email
- jose.ferreirapeneda@ulsm.min-saude.pt
- Contact Person Name
- José Ferreira Peneda
- Contact Person Email
- jose.ferreirapeneda@ulsm.min-saude.pt
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Otorhinolaryngology service
- Principal Investigator Name
- Francisco da Silva
- Principal Investigator Email
- fmoreiradasilva@gmail.com
- Contact Person Name
- Francisco da Silva
- Contact Person Email
- fmoreiradasilva@gmail.com
- Site Name
- Unidade Local De Saude Da Regiao De Aveiro E.P.E.
- Department Name
- Otorhinolaryngology service
- Principal Investigator Name
- Maria Luisa Azevedo
- Principal Investigator Email
- maria.azevedo.11348@chbv.min-saude.pt
- Contact Person Name
- Maria Luisa Azevedo
- Contact Person Email
- maria.azevedo.11348@chbv.min-saude.pt
Italy
- Earliest CTIS Part Ii Submission Date
- 10-12-2024
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 409
- Number Of Sites
- 7
- Number Of Participants
- 11
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C Otorinolaringoiatria
- Principal Investigator Name
- Jacopo Galli
- Principal Investigator Email
- Jacopo.galli@unicatt.it
- Contact Person Name
- Jacopo Galli
- Contact Person Email
- Jacopo.galli@unicatt.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- 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
- Site Name
- Instituto Di Ricovero E Cura A Carattere Scientifico
- Department Name
- UOC Otorinolaringoiatria
- Principal Investigator Name
- Ernesto Pasquini
- Principal Investigator Email
- e.pasquini@ausl.bo.it
- Contact Person Name
- Ernesto Pasquini
- Contact Person Email
- e.pasquini@ausl.bo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
- Department Name
- U.O.C Otorinolaringoiatria
- Principal Investigator Name
- Giorgia Carlotta Pipolo
- Principal Investigator Email
- carlotta.pipolo@gmail.com
- Contact Person Name
- Giorgia Carlotta Pipolo
- Contact Person Email
- carlotta.pipolo@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- SOD Immunoallergolagia
- 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
- Azienda Ospedaliera di Padova
- Department Name
- 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
- IRCCS Ospedale Policlinico San Martino
- Department Name
- UOC Otorinolaringoiatria
- Principal Investigator Name
- Frank Rikki Mauritz Canevari
- Principal Investigator Email
- frank.canevari@unige.it
- Contact Person Name
- Frank Rikki Mauritz Canevari
- Contact Person Email
- frank.canevari@unige.it
Germany
- Earliest CTIS Part Ii Submission Date
- 10-12-2024
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 399
- Number Of Sites
- 8
- Number Of Participants
- 18
Sites
- Site Name
- HNO Praxis Landsberg
- Principal Investigator Name
- Christian Korte
- Principal Investigator Email
- c.korte@hno-landsberg.com
- Contact Person Name
- Christian Korte
- Contact Person Email
- c.korte@hno-landsberg.com
- Site Name
- HNO-Praxis Eidelstedter Platz GbR
- Principal Investigator Name
- Thiemo Kurzweg
- Principal Investigator Email
- kurzweg@hno-eidelstedt.de
- Contact Person Name
- Thiemo Kurzweg
- Contact Person Email
- kurzweg@hno-eidelstedt.de
- Site Name
- Dr. med. Jan-Christof Bohn Facharzt für HNO-Heilkunde/Allergologie
- Principal Investigator Name
- Jan-Christof Bohn
- Principal Investigator Email
- jachribo@aol.com
- Contact Person Name
- Jan-Christof Bohn
- Contact Person Email
- jachribo@aol.com
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- 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
- 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
- Contact Person Email
- jan.hagemann@allergiezentrum.org
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- 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
- Contact Person Email
- Sven.Becker@med.uni-tuebingen.de
- Site Name
- Universitaet Muenster
- Department Name
- 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
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- HNO-Klinik
- Principal Investigator Name
- Heidi Olze
- Principal Investigator Email
- Heidi.olze@charite.de
- Contact Person Name
- Heidi Olze
- Contact Person Email
- Heidi.olze@charite.de
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
- Interactive response technologies (IRT)
- Name
- Bioclinica Inc.
- Responsibilities
- Central imaging
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- [code: 4]
- Name
- Rules Based Medicine Inc.
- Responsibilities
- [code: 4]
Third parties
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"[code: 14]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Marken","duties_or_roles":"[code: 14]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Interactive response technologies (IRT)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"[code: 7]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"[code: 4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Inato","duties_or_roles":"[code: 2]","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"[code: 14]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medpoint Communications Inc.","duties_or_roles":"[code: 8]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"[code: 4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"[code: 7]","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"European Pharma Hub Kft.","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
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 150 mg/ml
- Investigational Product Name
- Matched placebo for test product
- Modality
- Other
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