Clinical trial • Not applicable • Respiratory
mepolizumab for Severe asthma|Eosinophilic asthma
Not applicable trial of mepolizumab for Severe asthma|Eosinophilic asthma. open-label. 166 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Severe asthma|Eosinophilic asthma
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 24-01-2024
- First CTIS Authorization Date
- 14-05-2024
Trial design
open-label Not applicable trial in France, Germany, Belgium and others.
- Open Label
- Yes
- Target Sample Size
- 166
- Trial Duration For Participant
- 730
Eligibility
Recruits 166 Vulnerable population selected (isVulnerablePopulationSelected=true). Written informed consent is required. No further details on assent or consent handling for vulnerable participants are provided in the available documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Written informed consent is required. No further details on assent or consent handling for vulnerable participants are provided in the available documents.
Inclusion criteria
- {"criterion_text":"- 1. Adults aged 18 years or over\n- 2. Participant has a confirmed asthma diagnosis with physician decision to initiate treatment with NUCALA\n- 3. Participants with ≥60% predicted FEV1 and ≤4 exacerbations per year, as confirmed by the physician.\n- 4. Written informed consent."}
Exclusion criteria
- {"criterion_text":"- 1. Investigator concerns about participant’s willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)\n- 2. Any NUCALA use in the 6 months prior to enrollment.\n- 3. Participants currently on maintenance oral corticosteroids (mOCS) or intramuscular corticosteroids.\n- 4. Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment.\n- 5. Participating in an interventional study with a treatment intervention.\n- 6. Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis).\n- 7. Current smokers."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months","definition_or_measurement_approach":"Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months (as stated: Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months)."}
Secondary endpoints
- {"endpoint_text":"- 1. • Clinically Significant Asthma Exacerbations (CSE) • CSE leading to hospitalization/Emergency room (ER) visits 2. • Achieving oral corticosteroids (OCS) sparing remission • Achieving 3-component clinical remission 3. Change in the 15-item mini-AQLQ overall score from baseline to 12 months","definition_or_measurement_approach":"1. Clinically Significant Asthma Exacerbations (CSE) and CSE leading to hospitalization/ER visits. 2. Achieving oral corticosteroids (OCS) sparing remission and achieving 3-component clinical remission. 3. Change in the 15-item mini-AQLQ overall score from baseline to 12 months (as stated in secondary endpoints)."}
Recruitment
- Planned Sample Size
- 166
- Recruitment Window Months
- 27
- Consent Approach
- Written informed consent from the participant is required. Subject information and informed consent form documents are available in multiple languages (documents listed for DE, FR, ENG, ITA, SPA, POL, DUT). No details on assent or additional age-specific consent procedures are provided in the available materials.
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 170
France
- Earliest CTIS Part Ii Submission Date
- 11-03-2024
- Latest Decision Or Authorization Date
- 08-10-2024
- Processing Time Days
- 211
- Number Of Sites
- 6
- Number Of Participants
- 24
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Centre Intégré d’Expertise et de Recherche sur l’Asthme
- Principal Investigator Name
- Gilles DEVOUASSOUX
- Principal Investigator Email
- gilles.devouassoux@chu-lyon.fr
- Contact Person Name
- Gilles DEVOUASSOUX
- Contact Person Email
- gilles.devouassoux@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service Pneumologie et Allergologie
- Principal Investigator Name
- Laurent GUILLEMINAULT
- Principal Investigator Email
- guilleminault.l@chu-toulouse.fr
- Contact Person Name
- Laurent GUILLEMINAULT
- Contact Person Email
- guilleminault.l@chu-toulouse.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service Asthme et Allergologie - Pneumologie
- Principal Investigator Name
- Naji KHAYATH
- Principal Investigator Email
- naji.khayath@chru-strasbourg.fr
- Contact Person Name
- Naji KHAYATH
- Contact Person Email
- naji.khayath@chru-strasbourg.fr
- Site Name
- Centre Hospitalier De Cannes Simone Veil
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Fabien ROLLAND
- Principal Investigator Email
- f.rolland@ch-cannes.fr
- Contact Person Name
- Fabien ROLLAND
- Contact Person Email
- f.rolland@ch-cannes.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Raphael LE MAO
- Principal Investigator Email
- raphael.lemao@chu-brest.fr
- Contact Person Name
- Raphael LE MAO
- Contact Person Email
- raphael.lemao@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service Pneumologie et Immuno-Allergologie
- Principal Investigator Name
- Stephanie FRY
- Principal Investigator Email
- stephanie.fry@chu-lille.fr
- Contact Person Name
- Stephanie FRY
- Contact Person Email
- stephanie.fry@chu-lille.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 26-03-2024
- Latest Decision Or Authorization Date
- 08-10-2024
- Processing Time Days
- 196
- Number Of Sites
- 7
- Number Of Participants
- 40
Sites
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik fuer Kardiologie, Pneumologie, Angiologie und Internistische Intensivmedizin
- Principal Investigator Name
- Michael Dreher
- Principal Investigator Email
- mdreher@ukaachen.de
- Contact Person Name
- Michael Dreher
- Contact Person Email
- mdreher@ukaachen.de
- Site Name
- Studienzentrum Dr. Keller
- Department Name
- Not applicable
- Principal Investigator Name
- Claus Keller
- Principal Investigator Email
- ckeller-studien@praxis-ckeller.de
- Contact Person Name
- Claus Keller
- Contact Person Email
- ckeller-studien@praxis-ckeller.de
- Site Name
- Pneumo Studien Darmstadt GmbH
- Department Name
- Not applicable
- Principal Investigator Name
- Andreas Forster
- Principal Investigator Email
- forster@pneumostudien-darmstadt.de
- Contact Person Name
- Andreas Forster
- Contact Person Email
- forster@pneumostudien-darmstadt.de
- Site Name
- Praxisgemeinschaft Weinkellerstrasse GbR
- Department Name
- Facharztpraxis Pneumologie
- Principal Investigator Name
- Matti Mehner
- Principal Investigator Email
- info@pg-weinkellerstrasse.de
- Contact Person Name
- Matti Mehner
- Contact Person Email
- info@pg-weinkellerstrasse.de
- Site Name
- Lungenpraxis Bonn
- Department Name
- Pneumologische Gemeinschaftspraxis
- Principal Investigator Name
- Stefan Pabst
- Principal Investigator Email
- pabst@lunge-bonn.de
- Contact Person Name
- Stefan Pabst
- Contact Person Email
- stephanie.fry@chu-lille.fr
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- Not applicable
- Principal Investigator Name
- Marc Kornmann
- Principal Investigator Email
- kornmann@ikf-pneumologie.de
- Contact Person Name
- Marc Kornmann
- Contact Person Email
- kornmann@ikf-pneumologie.de
- Site Name
- Pneumologie, Allergologie Praxis Dr. Thomas Ginko
- Department Name
- Not applicable
- Principal Investigator Name
- Thomas Ginko
- Principal Investigator Email
- tginko@gmail.com
- Contact Person Name
- Thomas Ginko
- Contact Person Email
- tginko@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 14-10-2024
- Processing Time Days
- 243
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Pneumology
- Principal Investigator Name
- Florence Schleich
- Principal Investigator Email
- fschleich@chu.ulg.ac.be
- Contact Person Name
- Florence Schleich
- Contact Person Email
- fschleich@chu.ulg.ac.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Pneumology/Allergy
- Principal Investigator Name
- Mathias Leys
- Principal Investigator Email
- mathias.leys@azgroeninge.be
- Contact Person Name
- Mathias Leys
- Contact Person Email
- mathias.leys@azgroeninge.be
Spain
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 26-06-2025
- Processing Time Days
- 468
- Number Of Sites
- 3
- Number Of Participants
- 36
Sites
- Site Name
- Pectus Respiratory Health S.L.
- Department Name
- Pneumology
- Principal Investigator Name
- JUAN ROLDAN SANCHEZ
- Principal Investigator Email
- juan.roldan@giromedinstitute.com
- Contact Person Name
- JUAN ROLDAN SANCHEZ
- Contact Person Email
- juan.roldan@giromedinstitute.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Pneumology
- Principal Investigator Name
- DAVID RAMOS BARBON
- Principal Investigator Email
- dramosb@santpau.cat
- Contact Person Name
- DAVID RAMOS BARBON
- Contact Person Email
- dramosb@santpau.cat
- Site Name
- Hospital Arnau De Vilanova De Valencia
- Department Name
- Pneumology
- Principal Investigator Name
- FERNANDO SANCHEZ-TORIL LOPEZ
- Principal Investigator Email
- Sancheztoril_fer@gva.es
- Contact Person Name
- FERNANDO SANCHEZ-TORIL LOPEZ
- Contact Person Email
- Sancheztoril_fer@gva.es
Italy
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 01-07-2025
- Processing Time Days
- 503
- Number Of Sites
- 8
- Number Of Participants
- 40
Sites
- Site Name
- Fondazione Policlinico Universitario Campus Bio-Medico
- Department Name
- Unit Internal medicine
- Principal Investigator Name
- Simone Scarlata
- Principal Investigator Email
- s.scarlata@policlinicocampus.it
- Contact Person Name
- Simone Scarlata
- Contact Person Email
- s.scarlata@policlinicocampus.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Dipartimento di Medicina Interna
- Principal Investigator Name
- Fulvio Braido
- Principal Investigator Email
- fulvio.braido@unige.it
- Contact Person Name
- Fulvio Braido
- Contact Person Email
- fulvio.braido@unige.it
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- Pneumology and Oncology department
- Principal Investigator Name
- Maria D'Amato
- Principal Investigator Email
- marielladam@hotmail.it
- Contact Person Name
- Maria D'Amato
- Contact Person Email
- marielladam@hotmail.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
- Department Name
- UO Pneumologia
- Principal Investigator Name
- Francesco Menzella
- Principal Investigator Email
- protocollo.aulss2@pecveneto.it
- Contact Person Name
- Francesco Menzella
- Contact Person Email
- protocollo.aulss2@pecveneto.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOSD DH Medicina Interna e malattie dell’apprato digerente
- Principal Investigator Name
- Cristiano Caruso
- Principal Investigator Email
- cristiano.caruso@policlinogemelli.it
- Contact Person Name
- Cristiano Caruso
- Contact Person Email
- cristiano.caruso@policlinogemelli.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- UOC Pneumology
- Principal Investigator Name
- Claudio Micheletto
- Principal Investigator Email
- micheletto.claudio@libero.it
- Contact Person Name
- Claudio Micheletto
- Contact Person Email
- micheletto.claudio@libero.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- Allergology and Clinical Immunology Unit
- Principal Investigator Name
- Stefano Del Giacco
- Principal Investigator Email
- delgiac@gmail.com
- Contact Person Name
- Stefano Del Giacco
- Contact Person Email
- delgiac@gmail.com
- Site Name
- Humanitas Research Hospital
- Department Name
- Pnueumology and Allergology
- Principal Investigator Name
- Francesca Puggioni
- Principal Investigator Email
- francesca.puggioni@humanitas.it
- Contact Person Name
- Francesca Puggioni
- Contact Person Email
- francesca.puggioni@humanitas.it
Poland
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 597
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Principal Investigator Name
- Aleksandra Wardzyńska
- Principal Investigator Email
- aleksandra.wardzynska@umed.lodz.pl
- Contact Person Name
- Aleksandra Wardzyńska
- Contact Person Email
- aleksandra.wardzynska@umed.lodz.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
- Department Name
- Clinical Department of Internal Diseases, Asthma and Allergy with Pediatric Ward
- Principal Investigator Name
- Piotr Kuna
- Principal Investigator Email
- piotr.kuna@icloud.com
- Contact Person Name
- Piotr Kuna
- Contact Person Email
- piotr.kuna@icloud.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Gdański Uniwersytet Medyczny
- Principal Investigator Name
- Marek Niedoszytko
- Principal Investigator Email
- mnied@gumed.edu.pl
- Contact Person Name
- Marek Niedoszytko
- Contact Person Email
- mnied@gumed.edu.pl
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- sponsor duties (codes: 1,10,11,12,13,2,5,6,7,8,9) as listed in CTIS third party entry; contact sm_clinopsams@syneoshealth.com
- Name
- eResearchTechnology GmbH
- Responsibilities
- respiratory equipment management, respiratory assessments; additional eCOA/respiratory assessment support; contact customercare@ert.com
- Name
- Eresearchtechnology Inc.
- Responsibilities
- eCOA management; contact customercare@ert.com
Third parties
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"codes: 1,10,11,12,13,2,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"respiratory equipment management, respiratory assessments; codes: 5,6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA management","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Nucala 100 mg solution for injection in pre-filled pen
- Active Substance
- mepolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg
- Frequency
- Monthly (as per protocol description: monthly NUCALA injection)
- Maximum Dose
- 100 mg per administration (maxDailyDoseAmount=100 mg)
- Investigational Product Name
- Nucala 100 mg solution for injection in pre-filled syringe
- Active Substance
- mepolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg
- Frequency
- Monthly (as per protocol description: monthly NUCALA injection)
- Maximum Dose
- 100 mg per administration (maxDailyDoseAmount=100 mg)
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