Clinical trial • Phase IV • Respiratory
LUNSEKIMIG for Chronic rhinosinusitis with nasal polyps
Phase IV trial of LUNSEKIMIG for Chronic rhinosinusitis with nasal polyps. open-label, none/not specified-controlled. 34 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Chronic rhinosinusitis with nasal polyps
- Trial Stage
- Phase IV
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 17-02-2025
- First CTIS Authorization Date
- 11-06-2025
Trial design
open-label, none/not specified-controlled Phase IV trial across 10 sites in Bulgaria, Belgium, Poland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 34
- Trial Duration For Participant
- 364
Eligibility
Recruits 34 adults.
Inclusion criteria
- {"criterion_text":"- Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol"}
- {"criterion_text":"- Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS)."}
- {"criterion_text":"- Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures."}
Exclusion criteria
- {"criterion_text":"- Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study."}
- {"criterion_text":"- Concurrent participation in any clinical study other than the parent study, including non-interventional studies."}
- {"criterion_text":"- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Change in SNOT-22 total score","definition_or_measurement_approach":"Change measured using the SNOT-22 patient-reported outcome instrument (SNOT-22 total score)."}
- {"endpoint_text":"- Change in rhinosinusitis visual analog scale (VAS)","definition_or_measurement_approach":"Change measured using the rhinosinusitis visual analog scale (VAS)."}
- {"endpoint_text":"- Change in University of Pennsylvania Smell Identification Test (UPSIT) score","definition_or_measurement_approach":"Change measured using the University of Pennsylvania Smell Identification Test (UPSIT) score."}
- {"endpoint_text":"- Serum lunsekimig concentrations","definition_or_measurement_approach":"Measured by serum concentration assays for lunsekimig."}
- {"endpoint_text":"- Anti-drug antibodies (ADA) against lunsekimig","definition_or_measurement_approach":"Measured by assays detecting anti-drug antibodies (ADA) against lunsekimig."}
Recruitment
- Planned Sample Size
- 34
- Recruitment Window Months
- 18
- Consent Approach
- Informed consent documents (subject information and informed consent forms) are provided for participating countries and are available in multiple language versions (document titles indicate English, French, Dutch, Polish, Bulgarian). Consent is obtained from the participant (adult participants); no pediatric assent process is specified in the record.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 33
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 04-03-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 101
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Medical Center Comac Medical Ltd.
- Department Name
- NAP
- Contact Person Name
- Nadya Georgieva
- Contact Person Email
- nadya.georgieva@comac-medical.com
- Site Name
- Medical Center Comac Medical Ltd.
- Department Name
- NAP
- Contact Person Name
- Nadya Georgieva
- Contact Person Email
- nadya.georgieva@comac-medical.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-05-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 344
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Otorhinolaryngology
- Contact Person Name
- Philippe Gevaert
- Contact Person Email
- philippe.gevaert@ugent.be
- Site Name
- UZ Leuven
- Department Name
- Otorhinolaryngology
- Contact Person Name
- Peter Hellings
- Contact Person Email
- peter.hellings@uzleuven.be
Poland
- Earliest CTIS Part Ii Submission Date
- 08-05-2025
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 356
- Number Of Sites
- 6
- Number Of Participants
- 26
Sites
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Otorynolaryngologii
- Contact Person Name
- Eliza Brozek-Madry
- Contact Person Email
- eliza.madry@gmail.co
- Site Name
- Centrum Medyczne All-Med Badania Kliniczne
- Department Name
- Centrum Medyczne All-Med, ul. Henryka Sienkiewicza 23, 30-03
- Contact Person Name
- Grazyna Pulka
- Contact Person Email
- pulkaallmed@gmail.com
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Klinika Otolaryngologii i Onkologii Laryngologicznej z Klinicznym Oddziałem Chirurgii Czaszkowo-Szcz
- Contact Person Name
- Dariusz Jurkiewicz
- Contact Person Email
- djurkiewicz@wim.mil.pl
- Site Name
- Pracownia Badan Klinicznych Salus
- Department Name
- Pracownia Badan Klinicznych Salus
- Contact Person Name
- Pawel Golach
- Contact Person Email
- pawel.golach@pbks.com.pl
- Site Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
- Department Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii
- Contact Person Name
- Michal Springer
- Contact Person Email
- Michal.springer.pl@gmail.com
- Site Name
- Provita Sp. z o.o.
- Department Name
- Centrum Medyczne Angelius Provita
- Contact Person Name
- Tomasz Grzegorzek
- Contact Person Email
- t.grzegorzek@angelius.org
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- [4]
- Name
- Charles River Laboratories Montreal ULC
- Responsibilities
- [4]
- Name
- Suvoda LLC
- Responsibilities
- [3]
- Name
- Medidata Solutions Inc.
- Responsibilities
- [7]
- Name
- eResearchTechnology GmbH / Eresearchtechnology Inc.
- Responsibilities
- [7]
Third parties
- {"country":"Bulgaria","full_name":"Comac Medical Ltd.","duties_or_roles":"[12,14,5]","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"[7]","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"[14]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[3]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[7]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"South Africa","full_name":"Farmovs (Pty) Ltd","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"[7]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SAR443765 / LUNSEKIMIG
- Active Substance
- LUNSEKIMIG
- Modality
- Other antibody
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised
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