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Clinical trial

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

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Last updated:25th Jan 2019
Identifier: NCT03782532

Brief Summary:
Primary Objective:
To evaluate the efficacy of dupilumab in patients with persistent asthma

Secondary Objectives:
- To evaluate the safety and tolerability of dupilumab
- To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life
- To evaluate dupilumab systemic exposure and immunogenicity

Detailed Description:
The total duration of study per patient is approximately 40 weeks, including 4 to 5 weeks of screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Actual Study Start Date: January 25, 2019
Estimated Primary Completion Date: April 2021
Estimated Study Completion Date: April 2021

- Experimental:
- Placebo Comparator: Placebo for dupilumab

Category Value
Date last updated at source 2019-06-06
Study type(s) Interventional
Expected enrolment 486
Study start date 2019-01-25
Estimated primary completion date 2021-04-01

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