Clinical trial • Phase IV • Respiratory

dupilumab for Asthma|Uncontrolled asthma

Phase IV trial of dupilumab for Asthma|Uncontrolled asthma.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Asthma|Uncontrolled asthma
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody|Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
18-06-2024
First CTIS Authorization Date
07-10-2024

Trial design

Advair HFA 230mcg/21mcg and Advair HFA 115 mcg/21 mcg (ICS/LABA comparator for ICS dose escalation to high dose ICS/LABA).-controlled Phase IV trial across 20 sites in Denmark, Germany, Poland.

Comparator
Advair HFA 230mcg/21mcg and Advair HFA 115 mcg/21 mcg (ICS/LABA comparator for ICS dose escalation to high dose ICS/LABA).
Biomarker Stratified
True, biomarker: baseline blood eosinophil count; strata: ≥300 cells/μL (~90% of population)
Target Sample Size
188
Trial Duration For Participant
364

Eligibility

Recruits 188 paediatric patients.

Vulnerable Population
Includes adolescents (12-17 years). The trial requires informed consent/assent: participants sign informed consent/assent forms; country-specific assent and caregiver/parental/legal guardian consent documents are provided (documents include Country ICF Assent and Country ICF Caregiver/Parental/Legal Guardian forms). Country ICF documents are available in country languages (Danish, German, Polish) and there are country-specific ICF/assent documents.

Inclusion criteria

  • {"criterion_text":"- Participants must be 12 to 80 years of age inclusive at the time of signing the informed consent/assent form with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document"}
  • {"criterion_text":"- Note: Other protocol-defined Inclusion criteria apply"}
  • {"criterion_text":"- Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasone propionate DPI (dry powder inhaler) or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1"}
  • {"criterion_text":"- Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study"}
  • {"criterion_text":"- Pre-bronchodilator FEV1, as defined in the protocol"}
  • {"criterion_text":"- Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol"}
  • {"criterion_text":"- Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period"}
  • {"criterion_text":"- ACQ-5 score ≥1.5 at screening (visit 1)"}
  • {"criterion_text":"- History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1"}
  • {"criterion_text":"- Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (~90% of population), as defined in the protocol"}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments"}
  • {"criterion_text":"- Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3)"}
  • {"criterion_text":"- A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol"}
  • {"criterion_text":"- Weight is less than 30 kilograms"}
  • {"criterion_text":"- Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years"}
  • {"criterion_text":"- Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the participant’s participation in the study, as defined in the protocol"}
  • {"criterion_text":"- Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period"}
  • {"criterion_text":"- Note: Other protocol-defined Exclusion criteria apply"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Annualized severe asthma exacerbation rate","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change in pre-bronchodilator Forced Expiratory Volume in the first second (FEV1)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in Asthma Control Questionnaire (ACQ-5)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion of participants achieving ACQ-5 <1.5","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in pre-bronchodilator FEV1","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in percent of predicted FEV1","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in peak expiratory flow (PEF)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in forced vital capacity (FVC)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in forced expiratory flow (FEF) 25-75%","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in FEV1:FVC ratio","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in post-bronchodilator FEV1","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to first severe exacerbation event","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of Treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
True, methods include banner advertisements, patient email outreach templates, website recruitment material, digital brochures and electronic referral/leaflet materials (documents available in German and Polish and English recruitment procedure documents).
Planned Sample Size
188
Recruitment Window Months
25
Consent Approach
Informed consent/assent is required. Participants (aged 12–80) sign informed consent or assent forms; adolescents (minors) have assent forms and parental/caregiver/legal guardian consent forms. Country-specific ICF and assent documents are provided (documents available for Denmark, Germany and Poland; recruitment and ICF documents available in English and country languages as listed).

Methods

  • Recruitment Procedure Description documents (English/Polish) outlining local recruitment processes
  • Banner ads (Germany) — 'Recruitment arrangements Banner Ads_German_Public' document
  • Patient email layouts (Germany, Poland) — 'Patient Email Layout_German_Public' and 'Recruitment E-Mail Polish Public'
  • Posters (Germany, Poland) — 'Poster Layout_German_Public' and 'Recruitment Poster Polish Public'
  • Recruitment leaflets/brochures (Germany, Poland) — 'Recruitment Leaflet_Geman_Public', 'Recruitment Brochure Polish Public', 'Recruitment Leaflet Polish Public'
  • Website recruitment material (Poland) — 'Recruitment Website Polish Public'
  • Referral fact card (Germany) — 'Recruitment arrangements Referral Fact Card_German_Public'
  • Study brochures and disease fact sheets (Poland, Germany) — 'Recruitment Study Brochure_German_Public', 'Recruitment Disease Fact Sheet Polish Public'

Geography

Total Number Of Sites
20
Total Number Of Participants
62

Denmark

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
27
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Hvidovre Hospital
Department Name
208001: Lungemedicinsk Afdeling
Principal Investigator Name
Charlotte Suppli Ulrik
Principal Investigator Email
charlotte.suppli.ulrik@regionh.dk
Contact Person Name
Charlotte Suppli Ulrik
Site Name
Region Hovedstaden
Department Name
208002: Lungemedicinsk Forskning
Principal Investigator Name
Asger Sverrild
Principal Investigator Email
asgersverrild@gmail.com
Contact Person Name
Asger Sverrild
Contact Person Email
asgersverrild@gmail.com
Site Name
Lillebaelt Hospital
Department Name
208003: Lungemedicinsk Forskningsenhed
Principal Investigator Name
Ole Hilberg
Principal Investigator Email
ole.hilberg@rsyd.dk
Contact Person Name
Ole Hilberg
Contact Person Email
ole.hilberg@rsyd.dk

Germany

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
406
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
IKF Pneumologie GmbH & Co. KG (Mainz)
Department Name
276003:Institut für klinische Forschung Pneumologie
Principal Investigator Name
Stephanie Korn
Principal Investigator Email
korn@ikf-pneumologie.de
Contact Person Name
Stephanie Korn
Contact Person Email
korn@ikf-pneumologie.de
Site Name
Lungenpraxis Hohenzollerndamm Research Center for Medical Studies
Department Name
276006:Pneumologie
Principal Investigator Name
Bjoern Martens
Contact Person Name
Bjoern Martens
Site Name
IKF Pneumologie GmbH & Co. KG (Frankfurt Am Main)
Department Name
276001:Pulmonology
Principal Investigator Name
Marc Oliver Kornmann
Principal Investigator Email
kornmann@ikf-pneumologie.de
Contact Person Name
Marc Oliver Kornmann
Contact Person Email
kornmann@ikf-pneumologie.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
276004:Pneumologie
Principal Investigator Name
Katrin Milger-Kneidinger
Principal Investigator Email
katrin.milger@med.uni-muenchen.de
Contact Person Name
Katrin Milger-Kneidinger
Site Name
POIS Sachsen GmbH
Department Name
276008: Pneumology
Principal Investigator Name
Falk Brunner
Principal Investigator Email
f.brunner@pois-sachsen.de
Contact Person Name
Falk Brunner
Contact Person Email
f.brunner@pois-sachsen.de
Site Name
Praxis fuer Pneumologie Schlafmedizin und Onkologie am Diako ... Partnerschaft
Department Name
276005:Pneumologie
Principal Investigator Name
Sabina Wehgartner-Winkler
Principal Investigator Email
sabina.winkler@t-online.de
Contact Person Name
Sabina Wehgartner-Winkler
Contact Person Email
sabina.winkler@t-online.de
Site Name
Velocity Clinical Research Germany GmbH
Department Name
276007: Pneumology
Principal Investigator Name
Nakul Modi
Principal Investigator Email
nmodi@velocityclinical.com
Contact Person Name
Nakul Modi
Contact Person Email
nmodi@velocityclinical.com
Site Name
KPPK GmbH
Department Name
276002: KPPK Studienzentrum
Principal Investigator Name
Olaf Schmidt
Principal Investigator Email
schmidt@kppk-gmbh.de
Contact Person Name
Olaf Schmidt
Contact Person Email
schmidt@kppk-gmbh.de

Poland

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
412
Number Of Sites
9
Number Of Participants
23

Sites

Site Name
Homeo Medicus Szczesiul sp.j.
Department Name
616002: NZOZ HOMEO MEDICUS Poradnia alergologiczna
Principal Investigator Name
Krzysztof Kowal
Principal Investigator Email
kowalkmd@umb.edu.pl
Contact Person Name
Krzysztof Kowal
Contact Person Email
kowalkmd@umb.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
616004: Klinika Alergologii
Principal Investigator Name
Marek Niedoszytko
Principal Investigator Email
mnied@gumed.edu.pl
Contact Person Name
Marek Niedoszytko
Contact Person Email
mnied@gumed.edu.pl
Site Name
"All-Med" Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy Marek Jutel
Department Name
616007: Pulmonology
Principal Investigator Name
Marek Jutel
Principal Investigator Email
marek.jutel@all-med.wroclaw.pl
Contact Person Name
Marek Jutel
Contact Person Email
marek.jutel@all-med.wroclaw.pl
Site Name
Diamond Clinic Sp. z o.o.
Department Name
616001: DIAMOND MEDICAL CENTER
Principal Investigator Name
Barbara Rewerska
Principal Investigator Email
barbara@diamondclinic.eu
Contact Person Name
Barbara Rewerska
Contact Person Email
barbara@diamondclinic.eu
Site Name
Lekarze Specjalisci J. Malolepszy I Partnerzy
Department Name
616006: pulmonology
Principal Investigator Name
Krzysztof Wytrychowski
Principal Investigator Email
anhw@op.pl
Contact Person Name
Krzysztof Wytrychowski
Contact Person Email
anhw@op.pl
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Department Name
616005: pulmonology
Principal Investigator Name
Grazyna Pulka
Principal Investigator Email
pulkaallmed@gmail.com
Contact Person Name
Grazyna Pulka
Contact Person Email
pulkaallmed@gmail.com
Site Name
Centrum Medycyny Oddechowej Mroz Sp. j.
Department Name
616003: pulmonology
Principal Investigator Name
Robert Mroz
Principal Investigator Email
robmroz@wp.pl
Contact Person Name
Robert Mroz
Contact Person Email
robmroz@wp.pl
Site Name
Michal Bogacki Dobrostan
Department Name
616008: Pulmonology
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
Etg Warszawa Sp. z o.o.
Department Name
616009: ETG Warszawa
Principal Investigator Name
Beata Adamczyk
Principal Investigator Email
b.adamczyk@etg-network.com
Contact Person Name
Beata Adamczyk
Contact Person Email
b.adamczyk@etg-network.com

Sponsor

Primary sponsor

Full Name
Regeneron Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
CRO; The study monitor confirms that the CRA who will supervise the trial will be a Parexel employee and CRA from Denmark will monitor the study.

Third parties

  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Clinical Supply","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 1; Clinical Supply; CRO; The study monitor confirms that the CRA who will supervise the trial will be a Parexel employee and CRA from Denmark will monitor the study.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Electronic Clinical Outcome Assessment (eCOA)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Spirometry / FeNO","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel Icon Clinical Research Limited","duties_or_roles":"Language Services; migration and screenshot review of the electronic screens of the ACQ5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Qualitymetric Incorporated LLC","duties_or_roles":"Questionnaires","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Core materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Clinical Supply","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Dupixent 300 mg solution for injection in pre-filled syringe
Active Substance
dupilumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Marketing authorisation (EU/1/17/1229/002) / authorised
Starting Dose
300 mg
Maximum Dose
600 mg (maxDailyDoseAmount field)
Investigational Product Name
Advair HFA 230mcg/21mcg
Active Substance
fluticasone propionate; salmeterol
Modality
Small molecule
Routes Of Administration
OTHER USE (pressurised inhalation, suspension)
Route
PRESSURISED INHALATION, SUSPENSION
Authorisation Status
Authorised (SmPC referenced)
Starting Dose
230 mcg fluticasone propionate / 21 mcg salmeterol (product name)
Maximum Dose
460 µg (maxDailyDoseAmount field)
Investigational Product Name
Advair HFA 115 mcg/21 mcg
Active Substance
fluticasone propionate; salmeterol
Modality
Small molecule
Routes Of Administration
OTHER USE (pressurised inhalation, suspension)
Route
PRESSURISED INHALATION, SUSPENSION
Authorisation Status
Authorised (SmPC referenced)
Starting Dose
115 mcg fluticasone propionate / 21 mcg salmeterol (product name)
Maximum Dose
230 µg (maxDailyDoseAmount field)
Investigational Product Name
Placebo matching to dupilumab
Modality
Other
Combination Treatment
Yes

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