Overview

This trial is active, not recruiting.

Condition asthma
Treatments dupilumab sar231893 (regn668), placebo
Phase phase 3
Sponsor Sanofi
Collaborator Regeneron Pharmaceuticals
Start date April 2015
End date November 2017
Trial size 1858 participants
Trial identifier NCT02414854, 2014-004940-36, EFC13579, U1111-1163-1293

Summary

Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 [REGN668]) in patients with persistent asthma.

Secondary Objectives:

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
Dupilumab dose 1 every 2 weeks (loading dose with a double dose) added to current controller medications
dupilumab sar231893 (regn668)
Pharmaceutical form:solution Route of administration: subcutaneous
(Experimental)
Dupilumab dose 2 every 2 weeks (loading dose with a double dose) added to current controller medications
dupilumab sar231893 (regn668)
Pharmaceutical form:solution Route of administration: subcutaneous
(Placebo Comparator)
Placebo (for dupilumab dose 1) every 2 weeks (loading dose with a double dose) added to current controller medications
placebo
Pharmaceutical form:solution Route of administration: subcutaneous
(Placebo Comparator)
Placebo (for dupilumab dose 2) every 2 weeks (loading dose with a double dose) added to current controller medications
placebo
Pharmaceutical form:solution Route of administration: subcutaneous

Primary Outcomes

Measure
Annualized rate of severe exacerbation events
time frame: 52 weeks
Absolute change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
time frame: Week 12

Secondary Outcomes

Measure
Percent change from baseline in pre-bronchodilator FEV1
time frame: Week 12
Absolute change from baseline in pre-bronchodilator FEV1
time frame: Weeks 2, 4, 8, 24, 36, and 52
Percent change from baseline in pre-bronchodilator FEV1
time frame: Weeks 2, 4, 8, 24, 36, and 52
Annualized rate of loss of asthma control (LOAC) event
time frame: 52 weeks
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
time frame: 52 weeks
Time to first severe exacerbation event
time frame: 52 weeks
Time to first loss of asthma control event
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 12 years old.

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. 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). - Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care. - Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, CT, MRI) available within 3 months prior to screening to exclude patients with suspected active or untreated latent tuberculosis. - 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Description The total duration of study period for each patient is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and posttreatment period of 12 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sanofi.