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Hives
PKM16982 Enrolling

Child Chronic Urticaria (Hives) Research Trial (40 Weeks)


Treatment: Injection Age: 2 Years

Individuals from 2 to 12 years of age with a diagnosis of uncontrolled chronic spontaneous urticaria (CSU) or chronic indicuble cold urticaria (CICU) for over 6 months are needed for this clinical trial.  Children with CSU or CICU must remain symptomatic at the time of screening despite regular H1-antihistamine treatment (or appropriate preventive measures for subjects with CICU).  Qualified individuals must have a body weight within 5 kg to less than 60 kg.

Participants will receive investigational treatment (active study drug) via injection.  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Total study duration lasts approximately 40 weeks and involves about 8 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: January 29, 2023

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) or Chronic Inducible Cold Urticaria (CICU)

ClinicalTrials.gov ID

NCT05526521

Sponsor

Sanofi

Study Description

  • Brief Summary:

    This is a multicenter, single-arm, 24-week treatment, Phase 3 PKM16982 study. The purpose of this study is to investigate the Pharmacokinetics (PK) and safety of dupilumab in children diagnosed with CSU or CICU who remain symptomatic despite the use of H1-antihistamine treatment and/or appropriate preventive measures. 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 8.

  • Condition or Disease:

    Chronic Spontaneous Urticaria

  • Intervention/Treatment:

    Drug: Dupilumab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    2 Years and 11 Years (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Participant must be >= 2 years to < 12 years of age, at the time of signing the informed consent. Participants who have a documented diagnosis of CSU or CICU >6 months prior to screening visit.
Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for >6 consecutive weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.
Participants with CICU (characterized by recurrent itchy wheals with or without angioedema due to cold for >6 weeks) who remain symptomatic at the time of screening despite the regular or as-needed use of H1-antihistamine or appropriate preventive measures.
Participants with CICU with a positive ice cube provocation test, presenting with a confluent hive/wheal on the exposed skin area, at the screening visit.
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/CICU. Presence of skin morbidities other than CSU/CICU that may interfere with the assessment of the study outcomes. Participants with a concurrent diagnosis of both CSU and CICU. 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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Nestor Cisneros

Pediatric Dermatologist

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