Evaluation of Dupilumab in Patients with Persistent Asthma

Phase 1

Conditions: Asthma
MedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2014-004940-36-ES

Lead Sponsor: Sanofi-aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1638

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, leukotrine 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

Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are ?18 years of age).
Weight is less than 30 kilograms.
Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
A subject who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
Clinical evidence or imaging (eg, chest X-ray, computed tomography) within 12 months of Visit 1 consistent with lung disease(s) other than asthma.
Current smoker or cessation of smoking within 6 months prior to Visit 1.
Previous smoker with a smoking history >10 pack-years.
Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>To evaluate the effect of dupilumab in improving patient-reported outcomes including health related quality of life.<br>To evaluate dupilumab systemic exposure and incidence of antidrug antibodies.;Primary end point(s): a) Annualized rate of severe exacerbation events <br>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<br>b) Week 12

Secondary Outcome Measures

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