Clinical trial • Phase IV • Respiratory
ITEPEKIMAB for Chronic rhinosinusitis without nasal polyps
Phase IV trial of ITEPEKIMAB for Chronic rhinosinusitis without nasal polyps.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Chronic rhinosinusitis without nasal polyps
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody|Other
Key dates
- Initial CTIS Submission Date
- 07-10-2024
- First CTIS Authorization Date
- 11-02-2025
Trial design
Randomised, itepekimab versus matched placebo for test product (placebo). dose and schedule not specified in the ctis record.-controlled Phase IV trial in Portugal, Poland, Italy and others.
- Randomised
- Yes
- Comparator
- Itepekimab versus Matched placebo for test product (placebo). Dose and schedule not specified in the CTIS record.
- Target Sample Size
- 56
Eligibility
Recruits 56 Vulnerable population flag is selected for the study. Participants must be adults (Participant must be 18 years of age or older). Subject information and informed consent forms (L1) and partner/pregnancy information documents are present in the application documents (multiple languages), indicating consent is obtained via participant ICF; no assent procedures are indicated (adults only)..
- 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: - Is not a women of childbearing potential (WOCBP). OR - 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
- Vulnerable population flag is selected for the study. Participants must be adults (Participant must be 18 years of age or older). Subject information and informed consent forms (L1) and partner/pregnancy information documents are present in the application documents (multiple languages), indicating consent is obtained via participant ICF; no assent procedures are indicated (adults only).
Inclusion criteria
- {"criterion_text":"- Participant must be 18 years of age or older."}
- {"criterion_text":"- Participants must have ongoing symptoms of nasal congestion/obstruction at least 12 consecutive weeks before Visit 1 and a Nasal Congestion Score (NCS) ≥2 at Visit 1 (day score) and Visit 2 (weekly average score)."}
- {"criterion_text":"- Participants must have sinus Total Symptom Score (sTSS) (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score)."}
- {"criterion_text":"- Participants must have at least one of the following features: -Prior sinonasal surgery (as protocol defined) for chronic rhinosinusitis (CRS). -Treatment with systemic corticosteroid(s) (SCS) within the prior 2 years before Screening (Visit 1) -Worsening symptoms of CRS in the past 2 years which would have required treatment with SCS, however participant is intolerant or has a contraindication to SCS."}
- {"criterion_text":"- Participants must have bilateral inflammation of paranasal sinuses with bilateral ethmoid and maxillary opacification on screening CT scan. Participants must have ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus by central reading of CT scan."}
- {"criterion_text":"- Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT22) score of ≥20 at Visit 1 and Visit 2."}
- {"criterion_text":"- Participants who have received a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before Visit 2."}
- {"criterion_text":"- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: - Is not a women of childbearing potential (WOCBP). OR - 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)."}
Exclusion criteria
- {"criterion_text":"- Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint."}
- {"criterion_text":"- Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil)."}
- {"criterion_text":"- Radiological suspicion or confirmed invasive or expansive fungal rhinosinusitis."}
- {"criterion_text":"- Have any clinically significant diseases or disorders (eg, cardiovascular, pulmonary, gastrointestinal, liver, kidney, neurological, musculoskeletal, endocrine, metabolic, psychiatric, physical impairment,) that, in the opinion of the Investigator, may put the subject at risk by participating in the study, or interfere with the subject’s intervention, assessment, or influence the results of the study, or have compliance issues with the study."}
- {"criterion_text":"- Sinus surgery within 6 months before Screening (Visit 1)"}
- {"criterion_text":"- Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2)."}
- {"criterion_text":"- Participants treated with other intranasal corticosteroid(s) (INCS) (only study provided AxMP [MFNS] is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as Xhance™ during the screening period."}
- {"criterion_text":"- Participants with a history of severe systemic hypersensitivity reaction to mAb."}
- {"criterion_text":"- Known allergy to itepekimab or to its excipients. Any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan","definition_or_measurement_approach":"Percent opacification volume of maxillary and ethmoid sinuses assessed by CT scan (change from baseline), assessed by central reading of CT scan."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in the sTSS","definition_or_measurement_approach":"Change from baseline in sinus Total Symptom Score (sTSS); patient-reported symptom score."}
- {"endpoint_text":"- Change from baseline in nasal congestion (NC) severity score, Anterior/posterior rhinorrhea severity score, Facial pain/pressure severity score, and Loss of smell severity score using the CRSsNP daily e diary","definition_or_measurement_approach":"Individual symptom severity scores (NC, rhinorrhea, facial pain/pressure, loss of smell) collected using the CRSsNP daily electronic diary; change from baseline."}
- {"endpoint_text":"- Change from baseline in SNOT22 total score","definition_or_measurement_approach":"Change from baseline in SNOT-22 total score (Sino-Nasal Outcome Test-22), a validated patient-reported outcome."}
- {"endpoint_text":"- Change from baseline in sinus opacification as measured by the Lund-Mackay (LMK) score and the modified LMK score","definition_or_measurement_approach":"Change from baseline in sinus opacification measured by Lund-Mackay (LMK) score and modified LMK score (radiological scoring)."}
- {"endpoint_text":"- Incidence of (treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment emergent serious adverse events (TESAEs), and treatment-emergent adverse events (TEAEs) leading to intervention discontinuation","definition_or_measurement_approach":"Safety endpoints: incidence of TEAEs, TEAESIs, TESAEs, and TEAEs leading to discontinuation as recorded during study follow-up."}
- {"endpoint_text":"- Itepekimab concentration in serum","definition_or_measurement_approach":"Itepekimab serum concentration measured by PK assays (serum sampling)."}
- {"endpoint_text":"- Incidence of treatment-emergent (TE) anti-itepekimab antibodies responses","definition_or_measurement_approach":"Incidence of treatment-emergent anti-itepekimab antibody responses detected by immunogenicity assays."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 56
- Recruitment Window Months
- 25
- Consent Approach
- Informed consent obtained via participant Informed Consent Form (ICF). Subject information and ICF documents (L1) and partner/pregnancy information documents are provided in multiple languages (documents available in EN, FR, PT, ES, PL, IT, NL, RO). Participants are adults (≥18) so consent is provided by the participant; no assent procedures are indicated.
Methods
- Social media posts — documents present (language-specific: EN, FR, NL, PL, IT, ES, PT) for digital outreach to potential participants.
- Digital marketing content and landing page — online recruitment materials and landing pages (language-specific) to direct potential participants to self-assessment/eligibility tools.
- Self-assessment tool/material — documents for potential participants to self-assess eligibility (present in multiple languages).
- PI-to-Dr letters / Dr-to-Dr referral letters — materials for physician-to-physician referral (country/language specific).
- PI-to-patient letters, flyers, posters, brochures, illustrative book for patients — printed/patient-facing recruitment materials (language/country specific).
- Referral slide deck — materials for HCP referral/education (language-specific).
- Global privacy policy and closure content — information governance and participant closure communications (language-specific).
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 53
Portugal
- Earliest CTIS Part Ii Submission Date
- 16-12-2024
- Latest Decision Or Authorization Date
- 17-03-2025
- Processing Time Days
- 91
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Unidade Local De Saude Da Regiao De Aveiro E.P.E.
- Department Name
- Serviço de Otorrinolaringologia
- 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
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Serviço de Otorrinolaringologia
- Principal Investigator Name
- Francisco da Silva
- Principal Investigator Email
- fmoreiradasilva@gmail.com
- Contact Person Name
- Francisco da Silva
- Contact Person Email
- fmoreiradasilva@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 278
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Promed P.Lach R.Glowacki Sp. j.
- Department Name
- Centrum Medyczne PROMED
- Principal Investigator Name
- Piotr Stefan Lach
- Principal Investigator Email
- piotr@cmpromed.pl
- Contact Person Name
- Piotr Stefan Lach
- Contact Person Email
- piotr@cmpromed.pl
- Site Name
- Santa Sp. z o.o.
- Principal Investigator Name
- Magdalena Joanna Jozefowicz-Korczynska
- Principal Investigator Email
- magdalena.jozefowicz-korczynska@ptg-network.com
- Contact Person Name
- Magdalena Joanna Jozefowicz-Korczynska
- Contact Person Email
- magdalena.jozefowicz-korczynska@ptg-network.com
- Site Name
- Szpital Swietego Lukasza S.A.
- Department Name
- Oddzial Otolaryngologii
- Principal Investigator Name
- Sarka Solecka
- Principal Investigator Email
- sarkasolecka@gmail.com
- Contact Person Name
- Sarka Solecka
- Contact Person Email
- sarkasolecka@gmail.com
- Site Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
- 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
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Klinika Otolaryngologii i Onkologii Laryngologicznej z Klinicznym Oddzialem Chirurgii
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 06-12-2024
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 412
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U.O. Otorinolaringoiatria Audiologia e Foniatria Universitaria
- Principal Investigator Name
- Veronica Seccia
- Principal Investigator Email
- v.seccia@ao-pisa.toscana.it
- Contact Person Name
- Veronica Seccia
- Contact Person Email
- v.seccia@ao-pisa.toscana.it
- Site Name
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Department Name
- Unit of Integrated Therapies in Otolaryngology
- Principal Investigator Name
- Manuele Casale
- Principal Investigator Email
- M.Casale@policlinicocampus.it
- Contact Person Name
- Manuele Casale
- Contact Person Email
- M.Casale@policlinicocampus.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Otolaryngology
- Principal Investigator Name
- Jacopo Galli
- Principal Investigator Email
- Jacopo.galli@unicatt.it
- Contact Person Name
- Jacopo Galli
- Contact Person Email
- Jacopo.galli@unicatt.it
Romania
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 11-06-2025
- Processing Time Days
- 146
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- Centrul Medical Diagnostic si Tratament Ambulator Neomed SRL
- Principal Investigator Name
- Anemone Lupescu
- Principal Investigator Email
- anemone@neomed.org
- Contact Person Name
- Anemone Lupescu
- Contact Person Email
- anemone@neomed.org
- Site Name
- Centrul De Excelenta In Rinologie S.R.L.
- Department Name
- SC Centrul de Excelenta in Rinologie SRL
- Principal Investigator Name
- Mihaela Roxana Mitroi
- Principal Investigator Email
- mhlmitroi@yahoo.com
- Contact Person Name
- Mihaela Roxana Mitroi
- Contact Person Email
- mhlmitroi@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 10-01-2025
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 271
- Number Of Sites
- 7
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Otorrinolaringología
- Principal Investigator Name
- JOSE MIGUEL VILLACAMPA
- Principal Investigator Email
- jmvillacampa@fjd.es
- Contact Person Name
- JOSE MIGUEL VILLACAMPA
- Contact Person Email
- jmvillacampa@fjd.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Servicio de Otorrinolaringología
- Principal Investigator Name
- Serafin Sanchez Gomez
- Principal Investigator Email
- sanchezsg@ono.com
- Contact Person Name
- Serafin Sanchez Gomez
- Contact Person Email
- sanchezsg@ono.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Otorrinolaringología
- Principal Investigator Name
- Secundino Gonzalez
- Principal Investigator Email
- ensayoscun@unav.es
- Contact Person Name
- Secundino Gonzalez
- Contact Person Email
- ensayoscun@unav.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Servicio de Otorrinolaringología
- Principal Investigator Name
- Xavier Gonzalez Compta
- Principal Investigator Email
- xgonzalez@bellvitgehospital.cat
- Contact Person Name
- Xavier Gonzalez Compta
- Contact Person Email
- xgonzalez@bellvitgehospital.cat
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Servicio de Otorrinolaringología
- 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 Del Mar
- Department Name
- Servicio de Otorrinolaringología
- 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 Universitario Virgen De La Macarena (additional listing)
- Department Name
- Servicio de Otorrinolaringología
France
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 143
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
- Department Name
- Groupe Hospitalier de la Rochelle Re Aunis
- Principal Investigator Name
- Jean-Paul Trijolet
- Principal Investigator Email
- jean-paul.trijolet@ght-atlantique17.fr
- Contact Person Name
- Jean-Paul Trijolet
- Contact Person Email
- jean-paul.trijolet@ght-atlantique17.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- 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
- Centre Hospitalier Regional De Marseille
- Department Name
- 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 Poitiers
- Department Name
- service ORL, de chirurgie Cervico-faciale et d’audiophonologie
- Principal Investigator Name
- Florent Carsuzaa
- Principal Investigator Email
- florent.carsuzaa@chu-poitiers.fr
- Contact Person Name
- Florent Carsuzaa
- Contact Person Email
- florent.carsuzaa@chu-poitiers.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-01-2025
- Latest Decision Or Authorization Date
- 17-09-2025
- Processing Time Days
- 251
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Pneumocare
- Principal Investigator Name
- Benoit J MARTINOT
- Principal Investigator Email
- martinot.j@respisom.be
- Contact Person Name
- Benoit J MARTINOT
- Contact Person Email
- martinot.j@respisom.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- ORL
- Principal Investigator Name
- Valerie Hox
- Principal Investigator Email
- valerie.hox@uclouvain.be
- Contact Person Name
- Valerie Hox
- Contact Person Email
- valerie.hox@uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- NKO
- Principal Investigator Name
- Philippe Gevaert
- Principal Investigator Email
- philippe.gevaert@ugent.be
- Contact Person Name
- Philippe Gevaert
- Contact Person Email
- philippe.gevaert@ugent.be
- Site Name
- UZ Leuven
- Department Name
- NKO
- Principal Investigator Name
- Peter Hellings
- Principal Investigator Email
- peter.hellings@uzleuven.be
- Contact Person Name
- Peter Hellings
- Contact Person Email
- peter.hellings@uzleuven.be
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Third parties
- {"country":"Spain","full_name":"Evidenze Health Espana S.L.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Regeneron Pharmaceuticals Inc.","duties_or_roles":"code:4","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":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"code:15; value:Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Inato","duties_or_roles":"code:2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"code:15; value:Central Medical Reading or Imaging Reading","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Romania","full_name":"Alliance Healthcare Romania 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":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A. (additional address)","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","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":"France","full_name":"Firalis","duties_or_roles":"code:4","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
- Investigational Product Name
- Matched placebo for test product
- Modality
- Other
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