Evaluation of Dupilumab in Patients with Persistent Asthma (Liberty Asthma Quest)

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Persistent Asthma - Liberty Asthma Quest

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004940-36-GB

Enrollment

1858

Registered

2015-03-26

Start date

2015-07-20

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: dupilumab Product Code: SAR231893 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Dupilumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults and adolescent patients with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria: - Existing treatment with medium to high dose ICS (=250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose =1 month prior to Visit 1. - Note for Japan: for subjects aged 18 years and older, ICS must be on =200 mcg of fluticasone propionate twice daily or equivalent; for subjects aged 12 to 17 years, ICS must be =100 mcg of fluticasone propionate twice daily or equivalent). - Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose =1 month prior to Visit 1. Are the trial subjects under 18? yes Number of subjects for this age range: 84 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 254

Exclusion criteria

Exclusion criteria: Patients 10 pack-years. Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of dupilumab (SAR231893 [REGN668]) in patients with persistent asthma.; Secondary Objective: To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in improving patient-reported outcomes including health related quality of life. To evaluate dupilumab systemic exposure and incidence of antidrug antibodies. ; Primary end point(s): a) Annualized rate of severe exacerbation events b) Absolute change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) ; Timepoint(s) of evaluation of this end point: a) 52 weeks b) Week 12	—

Measure

Time frame

Main Objective: To evaluate the efficacy of dupilumab (SAR231893 [REGN668]) in patients with persistent asthma.; Secondary Objective: To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in improving patient-reported outcomes including health related quality of life. To evaluate dupilumab systemic exposure and incidence of antidrug antibodies. ; Primary end point(s): a) Annualized rate of severe exacerbation events b) Absolute change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) ; Timepoint(s) of evaluation of this end point: a) 52 weeks b) Week 12

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Secondary

Measure	Time frame
Secondary end point(s): a) Percent change from baseline in pre-bronchodilator FEV1 b) Absolute change from baseline in pre-bronchodilator FEV1 c) Percent change from baseline in pre-bronchodilator FEV1 d) Annualized rate of loss of asthma control (LOAC) event e) Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit f) Time to first severe exacerbation event g) Time to first loss of asthma control event ; Timepoint(s) of evaluation of this end point: a) Week 12 b) Weeks 2, 4, 8, 24, 36, and 52 c) Weeks 2, 4, 8, 24, 36, and 52 d) 52 weeks e) 52 weeks f) 52 weeks g) 52 weeks	—

Measure

Time frame

Secondary end point(s): a) Percent change from baseline in pre-bronchodilator FEV1 b) Absolute change from baseline in pre-bronchodilator FEV1 c) Percent change from baseline in pre-bronchodilator FEV1 d) Annualized rate of loss of asthma control (LOAC) event e) Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit f) Time to first severe exacerbation event g) Time to first loss of asthma control event ; Timepoint(s) of evaluation of this end point: a) Week 12 b) Weeks 2, 4, 8, 24, 36, and 52 c) Weeks 2, 4, 8, 24, 36, and 52 d) 52 weeks e) 52 weeks f) 52 weeks g) 52 weeks

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Countries

Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactMedical Information

Sanofi-aventis Recherche & Développement

uk-medicalinformation@sanofi.com+441483505515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026