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Clinical Trials/JPRN-jRCT2031220733
JPRN-jRCT2031220733
Recruiting
Phase 3

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)

Tanaka Tomoyuki0 sites24 target enrollmentMarch 26, 2023
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Tanaka Tomoyuki
Enrollment
24
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 26, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Tanaka Tomoyuki

Eligibility Criteria

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:
  • •Medical conditions
  • •\- 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.

Outcomes

Primary Outcomes

Not specified

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