Purpose

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.

Condition

Eligibility

Eligible Ages
Between 2 Years and 11 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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
  • Drug: Dupilumab
    Injection solution Subcutaneous
    Other names:
    • Dupixent

Recruiting Locations

Monroe Carell Jr. Childrens Hospital at Vanderbilt Site Number : 8400005
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
Contact-US@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.