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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05526521
Other study ID # PKM16982
Secondary ID U1111-1266-56692
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 25, 2022
Est. completion date July 7, 2025

Study information

Verified date June 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-US@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study is 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 include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 6.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 7, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years to 11 Years
Eligibility Inclusion Criteria: - Participant must be = 2 years to <12 years of age, at the time of signing the informed consent. - Participants who have 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 are 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 patient'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.

Study Design


Intervention

Drug:
Dupilumab
Injection solution Subcutaneous

Locations

Country Name City State
Canada 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
Japan Investigational Site Number : 3920002 Tsu-shi Mie
Japan Investigational Site Number : 3920001 Yokohama-shi Kanagawa
United States Treasure Valley Medical Research Site Number : 8400019 Boise Idaho
United States Cincinnati Children's Hospital Medical Center - PIN Site Number : 8400001 Cincinnati Ohio
United States Pediatric Dermatology of Miami Site Number : 8400015 Coral Gables Florida
United States Boston Childrens Health Physicians Site Number : 8400017 Hawthorne New York
United States Monroe Carell Jr. Childrens Hospital at Vanderbilt Site Number : 8400005 Nashville Tennessee
United States Columbia University Irving Medical Center Site Number : 8400003 New York New York
United States Washington University School of Medicine Site Number : 8400004 Saint Louis Missouri
United States Vital Prospects Clinical Research Institute, P.C. Site Number : 8400002 Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24 Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24. Week 12 and Week 24
Secondary Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs). Baseline to Week 36
Secondary Incidence of anti-drug antibodies (ADA) to dupilumab over time Incidence of anti-drug antibodies (ADA) to dupilumab over time. Baseline to Week 36
Secondary Change from baseline in Children's Dermatology Quality Life Index (C-DLQI) in children from 4 years to less than 12 years of age at Week 24 The C-DLQI is a validated questionnaire designed to measure the impact of skin disease on children's Health-Related Quality of Life (HRQoL). The questionnaire is validated for children aged =4 to <16 years. The C-DLQI total score ranges 0 to 30. The higher the score, the greater the impact is on the child's HRQoL. Baseline to Week 24
Secondary Change from baseline in Infants' Dermatitis Quality of Life Index (IDQOL) in children from 2 years to less than 4 years of age at Week 24 The IDQOL is a validated questionnaire designed for use in children aged <4 years. The IDLQI total score ranges 0 to 30. The higher the score, the greater the impact is on the child's HRQoL. Baseline to Week 24
Secondary Change from baseline in the modified Urticaria Activity Score (UAS7) at Week 24 The UAS is a validated patient reported outcome (PRO) measure. A modified version of the UAS (mUAS) will be used in this study to account for the smaller body surface area of child and adolescent patients. Daily mUAS scores are summed over 7-day period to create the mUAS7, ranging from 0 to 42. The higher score indicates the greater urticaria activity. Baseline to Week 24
Secondary Change from baseline in the modified itch severity score over 7 days (ISS7) at Week&nbsp;24 ISS ranges from 0 (absent) to 3 (intense). Daily ISS scores are summed over 7-day period to create the ISS7, ranging from 0 to 21. Baseline to Week 24
Secondary Change from baseline in the modified Hive Severity Score over 7 days (HSS7) at Week 24 HSS ranges from 0 (absent) to 3 (intense, (>30 wheals/24 hours or large confluent areas of wheals). Daily HSS scores are summed over 7-day period to create the HSS7, ranging from 0 to 21. Baseline to Week 24
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