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)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Chronic Spontaneous Urticaria

Treatments

Drug: Dupilumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05526521

2022-000260-22 (EudraCT Number)

PKM16982

U1111-1266-5669 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

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.