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)

NCT05526521 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: PKM16982U1111-1266-56692022-000260-22
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• Serum Concentration of Dupilumab at Weeks 12 and 24

  Blood samples were collected at specified timepoints to obtain dupilumab concentration.

  Weeks 12 and 24

Secondary Outcomes (7)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

  From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks

• Number of Participants With Anti-drug Antibodies (ADAs) to Dupilumab

  From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks

• Change From Baseline in Children's Dermatology Life Quality Index (C-DLQI) in Participants Aged 4 Years to <12 Years at Week 24

  Baseline (Day 1) and Week 24

• Change From Baseline in Infant's Dermatitis Quality of Life Index (IDQOL) in Participants Aged 2 Years to <4 Years at Week 24

  Baseline (Day 1) and Week 24

• Change From Baseline in Modified Urticaria Activity Score Over 7 Days (mUAS7) at Week 24

  Baseline (Day -7 to Day 1) and Week 24

Study Arms (1)

Dupilumab

EXPERIMENTAL

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

Drug: Dupilumab

Interventions

Dupilumab DRUG

Injection solution Subcutaneous

Also known as: Dupixent

Dupilumab

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (15)

Pediatric Dermatology of Miami Site Number : 8400015

Coral Gables, Florida, 33146, United States

Location

Treasure Valley Medical Research Site Number : 8400019

Boise, Idaho, 83706, United States

Location

Washington University School of Medicine- Site Number : 8400004

St Louis, Missouri, 63110, United States

Location

Boston Childrens Health Physicians Site Number : 8400017

Hawthorne, New York, 10532, United States

Location

Columbia University Irving Medical Center Site Number : 8400003

New York, New York, 10032, United States

Location

Childrens Hospital Medical Center of Akron- Site Number : 8400020

Akron, Ohio, 44308, United States

Location

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

Cincinnati, Ohio, 45229-3026, United States

Location

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

Tulsa, Oklahoma, 74136, United States

Location

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

Nashville, Tennessee, 37232, United States

Location

Investigational Site Number : 1240009

Calgary, Alberta, T2W 4X9, Canada

Location

Investigational Site Number : 1240010

Edmonton, Alberta, T5J 3S9, Canada

Location

Investigational Site Number : 1240007

Hamilton, Ontario, L8S1G5, Canada

Location

Investigational Site Number : 1240001

Montreal, Quebec, H4A 3J1, Canada

Location

Investigational Site Number : 3920001

Yokohama, Kanagawa, 232-8555, Japan

Location

Investigational Site Number : 3920002

Tsu, Mie-ken, 514-0125, Japan

Location

Related Links

• PKM16982 Plain Language Results Summary

MeSH Terms

Conditions

Chronic Urticaria

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: August 25, 2022
• Primary Completion: November 11, 2024
• Study Completion: February 3, 2025
• Last Updated: November 25, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (9); CA (4); JP (2)