An Evaluation of Dupilumab in Patients with Moderate to Severe Uncontrolled Asthma

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients with Moderate to Severe Uncontrolled Asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000856-16-IT

Enrollment

1500

Registered

2013-05-06

Start date

2013-06-19

Completion date

Unknown

Last updated

2015-12-22

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

Conditions

Asthma MedDRA version: 14.1 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 Current Sponsor code: SAR231893 Other descriptive name: REGN668 Concentration unit: mg/ml milligram(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with a physician diagnosis of moderate to severe, uncontrolled asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and: - Existing treatment with moderate- or high-dose inhaled corticosteroid / long-acting beta-2 agonist - Forced expiratory volume (FEV1) 40 to 80% of predicted normal - Juniper Asthma Control Questionnaire, 5-question version (ACQ-5) score =1.5 - Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1) - Has experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1470 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Patients 10 pack-years

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe, uncontrolled asthma;Secondary Objective: To evaluate different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma, with regard to: - Safety and tolerability - Dupilumab systemic exposure and anti-drug antibodies ;Primary end point(s): Change from baseline in forced expiratory volume (FEV1);Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe, uncontrolled asthma;Secondary Objective: To evaluate different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma, with regard to: - Safety and tolerability - Dupilumab systemic exposure and anti-drug antibodies ;Primary end point(s): Change from baseline in forced expiratory volume (FEV1);Timepoint(s) of evaluation of this end point: Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Relative change from baseline in FEV1 2) Annualized rate of loss of asthma control 3) Time to loss of asthma control 4) Change from baseline in asthma symptom scores;Timepoint(s) of evaluation of this end point: 1/4) Week 12 2/3) Week 24	—

Countries

Argentina, Australia, Chile, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Russian Federation, South Africa, Spain, Turkey, Ukraine, United States

Outcome results

None listed

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