Clinical trial • Phase III • Respiratory | Other
LEBRIKIZUMAB for Chronic rhinosinusitis with nasal polyps
Phase III trial of LEBRIKIZUMAB for Chronic rhinosinusitis with nasal polyps.
Overview
- Trial Therapeutic Area
- Respiratory | Other
- Trial Disease
- Chronic rhinosinusitis with nasal polyps
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 12-04-2024
- First CTIS Authorization Date
- 30-07-2024
Trial design
Randomised, placebo for lebrikizumab (matching placebo arm). background intranasal corticosteroid (mometasone furoate nasal spray) used as background therapy. specific lebrikizumab dose and schedule not specified in the provided data.-controlled Phase III trial in Spain, Hungary, Belgium and others.
- Randomised
- Yes
- Comparator
- Placebo for Lebrikizumab (matching placebo arm). Background intranasal corticosteroid (mometasone furoate nasal spray) used as background therapy. Specific lebrikizumab dose and schedule not specified in the provided data.
- Target Sample Size
- 748
- Trial Duration For Participant
- 168
Eligibility
Recruits 748 paediatric patients.
- Pregnancy Exclusion
- 11. Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.
- Vulnerable Population
- Vulnerable population selected: the trial includes minors/adolescents. Pediatric-specific consent and assent procedures are provided (Pediatric Consent 12-17, Pediatric Assent forms for 11-14 and 15-17, Parental/Parental ICFs). Parental/guardian consent is required for minors with age-appropriate assent; dedicated parental and pediatric information and consent/assent forms are provided and available in multiple country-specific versions.
Inclusion criteria
- {"criterion_text":"- 1. Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP)."}
- {"criterion_text":"- 2. Prior treatment with systemic corticosteroids (SCS) for CRS or CRSwNP within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both."}
- {"criterion_text":"- 3. Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline."}
- {"criterion_text":"- 4. Ongoing symptoms for at least 8 weeks prior to study entry (screening), including: a. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and b. At least one other symptom, such as, but not limited to, partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea."}
- {"criterion_text":"- 4.a. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization."}
- {"criterion_text":"- 4.b. At least one other symptom, such as, but not limited to, partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea."}
- {"criterion_text":"- 5. Patients who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment."}
Exclusion criteria
- {"criterion_text":"- 1. Have received a dose of lebrikizumab."}
- {"criterion_text":"- 2. Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period."}
- {"criterion_text":"- 3. Allergen immunotherapy (subcutaneous immunotherapy [SCIT]/sublingual immunotherapy [SLIT]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening) or may require a dose change during study."}
- {"criterion_text":"- 4. Prior or current biologic treatment for CRSwNP and/or asthma and/or atopic dermatitis (AD), including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab."}
- {"criterion_text":"- 5. Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:"}
- {"criterion_text":"- 5.a. B cell-depleting biologics, including rituximab, within 6 months."}
- {"criterion_text":"- 5.b. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer."}
- {"criterion_text":"- 5.c. Systemic immunosuppressants within 4 weeks prior to baseline."}
- {"criterion_text":"- 6. Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening"}
- {"criterion_text":"- 7. Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS"}
- {"criterion_text":"- 8. Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:"}
- {"criterion_text":"- 8.a. Nasal septal deviation occluding at least one nostril."}
- {"criterion_text":"- 8.b. Antrochoanal polyps."}
- {"criterion_text":"- 8.c. Acute sinusitis, acute nasal infection, or acute upper respiratory infection."}
- {"criterion_text":"- 8.d. Ongoing rhinitis medicamentosa."}
- {"criterion_text":"- 8.e. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young’s syndrome, primary ciliary dyskinesia, cystic fibrosis)."}
- {"criterion_text":"- 8.f. A nasal cavity tumor (malignant or benign)."}
- {"criterion_text":"- 8.g. Evidence of fungal rhinosinusitis."}
- {"criterion_text":"- 9. Have anosmia from COVID or any reason other than CRSwNP."}
- {"criterion_text":"- 10. Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening."}
- {"criterion_text":"- 11. Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity","definition_or_measurement_approach":"Participant-reported Nasal Congestion Score (NCS) severity recorded by study participants using a 4-point scale (0-3) in the participant eDiary; Time Frame: Baseline, Week 24."}
- {"endpoint_text":"- NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary. [Time Frame: Baseline, Week 24]","definition_or_measurement_approach":"NCS: 4-point scale (0=no symptoms, 3=severe); participants record prior 24 hours in eDiary. Time points: Baseline and Week 24."}
- {"endpoint_text":"- 2. Mean CFBL in Endoscopic Nasal Polyp Score (NPS)","definition_or_measurement_approach":"Endoscopic NPS assessed by centralized, blinded, independent review of nasal endoscopy video recordings. Total score is sum of right and left nasal cavity scores; each cavity graded 0-4 based on polyp size. [Time Frame: Baseline, Week 24]"}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 748
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent is obtained using country- and population-specific ICFs. For adults the Main ICF is used; for minors pediatric consent (12-17) and pediatric assent forms (11-14, 15-17) plus Parental/Parental ICFs are provided. Additional ICFs include pregnant partner ICFs and optional sub-study ICFs. Consent/assent materials are provided in multiple country/language versions (country-specific ICF documents listed for ES, DE, IT, BE, PL, RO, PT, HU, BG, etc.).
Methods
- Social media advertisements (assets: Social_1080x1080, Social_1200x628, Social-Media-Ads) — country-specific versions available (e.g., ES, DE, BE, IT, PL, RO, BG, PT, HU). Target: patients with CRSwNP / general public likely to have symptoms.
- Landing pages / URLs (SS_Landing Page, SYN_Landing Page) — country-specific landing pages to capture interest and direct potential participants to screening (several language/country versions present).
- Patient letters and GP/Doctor-to-Patient letters — to inform and recruit patients via healthcare providers (country-specific patient letters present for ES, BE, IT, DK, RO, PT, PL, HU, BG, etc.).
- Posters, flipcharts, recruitment brochures — printed/study-team materials for clinic and community recruitment (country-specific posters and brochures).
- Patient referral questionnaire and AES Patient Referral Questionnaires — tools to capture patient referrals and pre-screening information.
- Keyword search / online ads (SS_KEYWORD-SEARCH) and URLs — digital outreach via search-targeted advertising.
- Video ICF and other multimedia information — used in some countries to inform participants.
- Study site outreach (clinic-based recruitment) — site lists show otorhinolaryngology/ENT departments and allergy clinics as recruitment venues.
Geography
- Total Number Of Sites
- 63
- Total Number Of Participants
- 272
Spain
- Earliest CTIS Part Ii Submission Date
- 17-06-2024
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 627
- Number Of Sites
- 9
- Number Of Participants
- 45
Sites
- Site Name
- Centro Medico Teknon-Grupo Quironsalud
- Department Name
- Otorhinolaryngology
- Contact Person Name
- Isam Alobid
- Contact Person Email
- ialobid@clinic.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Otorhinolaryngology
- Contact Person Name
- Jose Villacampa
- Contact Person Email
- jmvillacampa@fjd.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Otorhinolaryngology
- Contact Person Name
- Serafin Sanchez Gomez
- Contact Person Email
- serafin.sanchez.sspa@juntadeandalucia.es
- Site Name
- Futuremeds Spain S.L.
- Department Name
- Allergy
- Contact Person Name
- Carolina Alfonso Carrillo
- Contact Person Email
- carolina.alfonso@futuremeds.com
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Department of Otorhinolaryngology
- Contact Person Name
- Cristobal Langdon Montero
- Contact Person Email
- cristobal.langdon@sjd.es
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Rhinology & Asthma Unit. ENT Department.
- Contact Person Name
- Alfonso Del Cuvillo
- Contact Person Email
- dr.cuvillo@comcadiz.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Otorhinolaryngology
- Contact Person Name
- Gabriel Martinez Capoccioni
- Contact Person Email
- gabriel.adolfo.martinez.capoccioni@sergas.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Allergy
- Contact Person Name
- Gabriel Gastaminza Lasarte
- Contact Person Email
- gastaminza@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz (additional listing)
- Department Name
- Otorhinolaryngology
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-08-2025
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 193
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
- Department Name
- Otolaringology
- Contact Person Name
- Irma Lehőcz
- Contact Person Email
- lehoczirma.study@gmail.com
- Site Name
- Ujpesti Egeszsegkoezpont
- Contact Person Name
- Attila Velich
- Contact Person Email
- velichattila@gmail.com
- Site Name
- Rhinoto Kft.
- Contact Person Name
- László Lujber
- Contact Person Email
- lujber@yahoo.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 589
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Otorhinolaryngology Department
- Contact Person Name
- Valérie Hox
- Contact Person Email
- valerie.hox@uclouvain.be
- Site Name
- Pneumocare
- Contact Person Name
- Jean Benoit Martinot
- Contact Person Email
- martinot.j@scralet.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Otorhinolaryngology Department
- Contact Person Name
- Philippe Gevaert
- Contact Person Email
- philippe.gevaert@uzgent.be
Germany
- Earliest CTIS Part Ii Submission Date
- 18-07-2024
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 574
- Number Of Sites
- 8
- Number Of Participants
- 39
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
- Contact Person Name
- Philipp Nahrath
- Contact Person Email
- philipp.nahrath@ukdd.de
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- N/A - Additional streetname as site is located at a corner: Stresemannallee 3
- Contact Person Name
- Marc Oliver Kornmann
- Contact Person Email
- kornmann@ikf-pneumologie.de
- Site Name
- HNO Praxis Dresden Dr. med. Udo Schäfer
- Contact Person Name
- Udo Schäfer
- Contact Person Email
- schaefer@hno-praxis-dresden.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Hals-, Nasen-, Ohrenheilkunde
- Contact Person Name
- Heidi Olze
- Contact Person Email
- heidi.olze@charite.de
- Site Name
- Praxis für HNO und Allergologie Dr. Yury Yarin
- Contact Person Name
- Yury Yarin
- Contact Person Email
- dr.yarin@googlemail.com
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Hals-, Nasen- und Ohrenheilkunde
- Contact Person Name
- Orlando Guntinas-Lichius
- Contact Person Email
- HNO-Studienbuero@med.uni-jena.de
- Site Name
- HNO Zentrum am Kudamm
- Contact Person Name
- Önder Göktas
- Contact Person Email
- goektas@hnozentrum-kudamm.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Sektion für Hals-, Nasen- und Ohrenheilkunde
- Contact Person Name
- Anke Leichtle
- Contact Person Email
- anke.leichtle@uksh.de
Italy
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 575
- Number Of Sites
- 8
- Number Of Participants
- 20
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Otorinolaringoiatria, Audiologia e Foniatria Universitaria
- Contact Person Name
- Veronica Seccia
- Contact Person Email
- v.seccia@ao-pisa.toscana.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Internal Medicine and Clinical Complexities
- Contact Person Name
- Aikaterini Detoraki
- Contact Person Email
- aikaterini.detoraki@unina.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Neurosciences DNS
- Contact Person Name
- Giancarlo Ottaviano
- Contact Person Email
- giancarlo.ottaviano@unipd.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- UOC Otorinolaringoiatria
- Contact Person Name
- Marco Mandalà
- Contact Person Email
- marco.mandala@unisi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Otorinolaringoiatria
- Contact Person Name
- Eugenio De Corso
- Contact Person Email
- eugenio.decorso@policlinicogemelli.it
- Site Name
- Azienda Socio Sanitaria Territoriale Della Brianza
- Department Name
- UOC Otorinolaringoiatria
- Contact Person Name
- Federico Giuseppe Quarta
- Contact Person Email
- federicogiuseppe.quarta@asst-brianza.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità Operativa di Otorinolaringoiatria
- Contact Person Name
- Giulia Dané
- Contact Person Email
- dane.giulia@hsr.it
- Site Name
- Careggi University Hospital
- Department Name
- Experimental and Clinical Medicine
- Contact Person Name
- Alessandra Vultaggio
- Contact Person Email
- alessandra.vultaggio@unifi.it
Denmark
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 584
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Region Sjaelland
- Department Name
- Oere-Naese-Hals og Kaebekirurgisk Afdeling
- Contact Person Name
- Preben Homoee
- Contact Person Email
- prho@regionsjaelland.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Respiratory Diseases
- Contact Person Name
- Ulla Weinreich
- Contact Person Email
- ulw@rm.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of Ear-Nose-Throat
- Contact Person Name
- Teis Ehlers Klug
- Contact Person Email
- tejsklug@rm.dk
Romania
- Earliest CTIS Part Ii Submission Date
- 29-04-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 658
- Number Of Sites
- 7
- Number Of Participants
- 38
Sites
- Site Name
- Delta Health Care S.R.L.
- Department Name
- Departament Otorinolaringologie (ORL)
- Contact Person Name
- Corina-Camelia Mella
- Contact Person Email
- corinamella@yahoo.com
- Site Name
- Delta Health Care S.R.L. (second listing)
- Department Name
- Departament Otorinolaringologie (ORL)
- Contact Person Name
- Jana-Sorina Dindere
- Contact Person Email
- sorina.dindere@reginamaria.ro
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Department Otorinolaringologie
- Contact Person Name
- Catalin Stefan
- Contact Person Email
- drcatalinstefan@gmail.com
- Site Name
- Cardiomed S.R.L.
- Department Name
- Departament Otorinolaringologie (ORL)
- Contact Person Name
- Gheorghe-Doinel Radeanu
- Contact Person Email
- doinelra@yahoo.com
- Site Name
- Centrul De Excelenta In Rinologie S.R.L.
- Department Name
- Department Otorinolaringologie
- Contact Person Name
- Mihaela-Roxana Mitroi
- Contact Person Email
- mhlmitroi@yahoo.com
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- Department Otorinolaringologie (ORL)
- Contact Person Name
- Valeriu Bronescu
- Contact Person Email
- bronescu@neomed.org
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. (second listing)
- Department Name
- Department Otorinolaringologie (ORL)
- Contact Person Name
- Anemone-Sorana Lupescu
- Contact Person Email
- anemone@neomed.org
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 586
- Number Of Sites
- 5
- Number Of Participants
- 27
Sites
- Site Name
- Medical Center Medconsult Pleven OOD
- Contact Person Name
- Georgi Nikolov
- Contact Person Email
- nikolov_medconsult@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
- Department Name
- Ear, nose and throat department
- Contact Person Name
- Dimitar Dimitrov
- Contact Person Email
- dr.dimitrovv@gmail.com
- Site Name
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
- Department Name
- Ear, nose and throat Clinic
- Contact Person Name
- Yulian Rangachev
- Contact Person Email
- rangachev@abv.bg
- Site Name
- Diagnostic Consultative Centre Ascendent EOOD
- Contact Person Name
- Emiliya Yordanova
- Contact Person Email
- emiliya.yordanova@futuremeds.bg
- Site Name
- Military Medical Academy
- Department Name
- Ear, nose and throat Clinic
- Contact Person Name
- Ventzislav Tzvetkov
- Contact Person Email
- vtcvetkov@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 593
- Number Of Sites
- 11
- Number Of Participants
- 51
Sites
- Site Name
- Centrum Medyczne All-Med Badania Kliniczne
- Contact Person Name
- Grażyna Pulka
- Contact Person Email
- pulkaallmed@gmail.com
- Site Name
- Niepubliczny Zakład Opieki Zdrowotnej EVita
- Contact Person Name
- Ewa Michnowska-Tryburska
- Contact Person Email
- drewam@o2.pl
- Site Name
- Centrum Medyczne Oporow
- Contact Person Name
- Yogen Abelak
- Contact Person Email
- yogen@abelak.com
- Site Name
- Centrum Medyczne Angelius Provita
- Contact Person Name
- Tomasz Grzegorzek
- Contact Person Email
- t.grzegorzek@angelius.org
- Site Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
- Contact Person Name
- Michał Springer
- Contact Person Email
- michal.springer.pl@gmail.com
- Site Name
- Centrum Medyczne Biotamed Morawska Barbara
- Contact Person Name
- Piotr Morawski
- Contact Person Email
- morawscy@op.pl
- Site Name
- Centrum Medyczne Pratia Katowice
- Contact Person Name
- Santa Vanaga-Besser
- Contact Person Email
- svbesser.pratia@gmail.com
- Site Name
- EMC Instytut Medyczny S.A. Przychodnia EuroMediCare, Wrocław Łowiecka
- Contact Person Name
- Marita Nittner-Marszalska
- Contact Person Email
- badania.kliniczne@pentahospitals.pl
- Site Name
- B&R Clinical Sp. z o.o.
- Contact Person Name
- Marcin Zawadzki
- Contact Person Email
- marcin.zawadzki@brclinical.pl
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Contact Person Name
- Dariusz Jurkiewicz
- Contact Person Email
- djurkiewicz@wim.mil.p
- Site Name
- Centrum Medyczne PROMED
- Contact Person Name
- Piotr Łach
- Contact Person Email
- badania.kliniczne@cmpromed.pl
Portugal
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 161
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- Site Name
- Unidade Local De Saude De Loures-Odivelas EPE
- Department Name
- Otorhinolaryngology Department
- Contact Person Name
- Luís Rodrigues
- Contact Person Email
- luisrodrigues@gmail.com
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Otorhinolaryngology Department
- Contact Person Name
- Luís Antunes
- Contact Person Email
- lantunes@ulsas.min-saude.pt
- Site Name
- Unidade Local De Saude De Matosinhos E.P.E.
- Department Name
- Otorhinolaryngology Service
- Contact Person Name
- Miguel Viana
- Contact Person Email
- miguel.viana@ulsm.min-saude.pt
- Site Name
- Unidade Local De Saude Do Algarve E.P.E.
- Department Name
- Otorhinolaryngology Unit
- Contact Person Name
- Natacha Santos
- Contact Person Email
- natacha.santos@ulsalg.min-saude.pt
- Site Name
- Unidade Local De Saude Da Regiao De Aveiro E.P.E.
- Department Name
- Otorhinolaryngology Service
- Contact Person Name
- Maria Luísa Azevedo
- Contact Person Email
- maria.azevedo.11348@ulsra.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Otorhinolaryngology Service
- Contact Person Name
- Daniel Miranda
- Contact Person Email
- jose.miranda@ulsb.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Wuxi Apptec Co. Ltd.
- Name
- PPD Development LP
- Name
- Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
- Name
- Labcorp Early Development Laboratories Inc.
- Name
- PPD Global Central Labs
- Name
- Q Squared Solutions LLC
- Name
- eResearchTechnology GmbH
- Name
- Clinical Ink Inc.
Third parties
- {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Lebrikizumab
- Active Substance
- LEBRIKIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Investigational Product Name
- Placebo for Lebrikizumab
- Modality
- Other
- Investigational Product Name
- MOMETASONE
- Active Substance
- MOMETASONE FUROATE
- Modality
- Small molecule
- Routes Of Administration
- Nasal spray
- Route
- Nasal spray
- Combination Treatment
- Yes
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