Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Sanofi
Study ID
NCT03560466
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab (SAR231893/REGN668) — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous (sc)
  • Asthma controller therapies (incl. prednisone/prednisolone) — DRUG
    Pharmaceutical form: powder, or solution, or pill Route of administration: inhaled, oral or parenteral
  • Asthma reliever therapies — DRUG
    Pharmaceutical form: powder or solution Route of administration: inhaled

Study Details

Primary Objective: * To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: * To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: * Systemic exposure. * Anti-drug antibodies (ADAs). * Biomarkers. * To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study * To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: * Systemic exposure, * Anti-drug antibodies (ADAs), * Biomarkers

Key Dates

Start date
Jun 21, 2018
Status verified
Nov 2025
Primary completion
Apr 1, 2025
Completion
Apr 1, 2025

Study Design

Enrollment
378 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks

Primary Outcome Measure

Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
Arizona Allergy and Immunology Research- Site Number : 8400002GilbertArizona85234-
Asthma and Airway Disease Research Center Site Number : 8400012TucsonArizona85274-
Peninsula Research Associates Site Number : 8400001Rolling Hills EstatesCalifornia90274-
Division of Pulmonary Medicine and Allergy Medicine- Site Number : 8400006St LouisMissouri63110-1077-
Somnos Clinical Research Site Number : 8400022LincolnNebraska68505-
Northwell Health- Site Number : 8400023Great NeckNew York11021-
Columbia University Medical Center- Site Number : 8400013New YorkNew York10032-
Rochester Regional Health- Site Number : 8400007RochesterNew York14607-
Immunocarolina LLC Site Number : 8400004CharlotteNorth Carolina28277-
Cincinnati Children's Hospital Medical Center Site Number : 8400008CincinnatiOhio45229-
OK Clinical Research, LLC- Site Number : 8400024EdmondOklahoma73034-
Allergy & Asthma Research Center- Site Number : 8400003San AntonioTexas78229-

Find similar trials in Gilbert, AZ

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Arizona Allergy and Immunology Research· Gilbert, AZAsthma and Airway Disease Research Center· Tucson, AZPeninsula Research Associates· Rolling Hills Estates, CADivision of Pulmonary Medicine and Allergy Medicine· St Louis, MOSomnos Clinical Research· Lincoln, NENorthwell Health· Great Neck, NY

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