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) or chronic inducible cold urticaria (CICU)

Phase 3

Recruiting

• Conditions: Chronic Cold UrticariaChronic Spontaneous Urticaria

• Registration Number: JPRN-jRCT2031220733
• Lead Sponsor: Tanaka Tomoyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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.
- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified