A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Sanofi
Study ID
NCT05526521
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    Injection solution Subcutaneous

Study Details

This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.

Key Dates

Start date
Aug 25, 2022
Status verified
Nov 2025
Primary completion
Nov 11, 2024
Completion
Feb 3, 2025

Study Design

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

Arms

  • Experimental: Dupilumab
    Administered subcutaneously (SC) every 4 weeks (Q4W) or every 2 weeks (Q2W) with or without an initial loading dose based on weight and age

Primary Outcome Measure

Serum Concentration of Dupilumab at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Pediatric Dermatology of Miami Site Number : 8400015Coral GablesFlorida33146-
Treasure Valley Medical Research Site Number : 8400019BoiseIdaho83706-
Washington University School of Medicine- Site Number : 8400004St LouisMissouri63110-
Boston Childrens Health Physicians Site Number : 8400017HawthorneNew York10532-
Columbia University Irving Medical Center Site Number : 8400003New YorkNew York10032-
Childrens Hospital Medical Center of Akron- Site Number : 8400020AkronOhio44308-
Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001CincinnatiOhio45229-3026-
Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002TulsaOklahoma74136-
Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005NashvilleTennessee37232-

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Pediatric Dermatology of Miami· Coral Gables, FLTreasure Valley Medical Research· Boise, IDWashington University School of Medicine· St Louis, MOBoston Childrens Health Physicians· Hawthorne, NYColumbia University Irving Medical Center· New York, NYChildrens Hospital Medical Center of Akron· Akron, OH

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