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)

Chronic Spontaneous Urticaria Clinical Trial

Official title:

A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: March 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
• 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.

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

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
Canada	Investigational Site Number : 1240006	Winnipeg	Manitoba
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