MedTrace Logo

Evaluation of Dupilumab in Children With Uncontrolled Asthma

NCT02948959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2022-03-28

Study results available
· View outcomes & findings →

Summary

Primary Objective:

To evaluate the efficacy of dupilumab in children 6 to less than (\<) 12 years of age with uncontrolled persistent asthma.

Secondary Objective:

To evaluate in children 6 to \<12 years of age with uncontrolled persistent asthma:

* The safety and tolerability of dupilumab.
* The evaluate the effect of dupilumab in improving participant reported outcomes including health related quality of life.
* The dupilumab systemic exposure and incidence of anti-drug antibodies.
* The evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.

Conditions

Interventions

DRUG

Dupilumab

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Asthma Controller Therapies

Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhaled, 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
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-21
Primary Completion
2020-08-26
Completion
2020-08-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Hungary
  • Italy
  • Lithuania
  • Mexico
  • Poland
  • Romania
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine

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 NCT02948959 on ClinicalTrials.gov