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)

NCT ID: NCT05526521

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2025-02-03

Brief Summary

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.

Conditions

Chronic Spontaneous Urticaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Injection solution Subcutaneous

Interventions

Dupilumab

Injection solution Subcutaneous

Intervention Type: DRUG

Other Intervention Names

Dupixent

Eligibility Criteria

Inclusion Criteria

• Participant must be ≥ 2 years to <12 years of age, at the time of signing the informed consent.
• Participants who had history of a diagnosis of CSU prior to screening (Visit 1) or symptoms consistent with a diagnosis of CSU for at least 3 months in the Investigator's opinion.
• Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for >6 weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.
• Body weight within ≥5 kg to <60 kg.
• Participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures.

Exclusion Criteria

Participants were excluded from the study if any of the following criteria apply:

• Underlying etiology for chronic urticarias other than CSU.
• Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.
• Participants with a diagnosis of chronic inducible cold urticaria.
• Participants with active AD.
• Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
• Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated.
• Diagnosed with, suspected of, or at high risk of endoparasitic infection.
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.
• Known or suspected immunodeficiency.
• Active malignancy or history of malignancy within 5 years before the baseline visit.
• History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient.
• Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pediatric Dermatology of Miami Site Number : 8400015

Coral Gables, Florida, United States

Treasure Valley Medical Research Site Number : 8400019

Boise, Idaho, United States

Washington University School of Medicine- Site Number : 8400004

St Louis, Missouri, United States

Boston Childrens Health Physicians Site Number : 8400017

Hawthorne, New York, United States

Columbia University Irving Medical Center Site Number : 8400003

New York, New York, United States

Childrens Hospital Medical Center of Akron- Site Number : 8400020

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001

Cincinnati, Ohio, United States

Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002

Tulsa, Oklahoma, United States

Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005

Nashville, Tennessee, United States

Investigational Site Number : 1240009

Calgary, Alberta, Canada

Investigational Site Number : 1240010

Edmonton, Alberta, Canada

Investigational Site Number : 1240007

Hamilton, Ontario, Canada

Investigational Site Number : 1240001

Montreal, Quebec, Canada

Investigational Site Number : 3920001

Yokohama, Kanagawa, Japan

Investigational Site Number : 3920002

Tsu, Mie-ken, Japan

Countries

United States; Canada; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25324&tenant=MT_SNY_9011

PKM16982 Plain Language Results Summary

Other Identifiers

U1111-1266-5669

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-000260-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PKM16982

Identifier Type: -

Identifier Source: org_study_id