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Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

NCT03782532 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2022-12-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

Dupilumab SAR231893

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Asthma Controller Therapies (include prednisone/prednisolone)

Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhalation, oral

DRUG

Asthma Reliever Therapies

Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2022-05-21
Completion
2022-05-21

Countries

  • China
  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782532 on ClinicalTrials.gov