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) (LIBERTY-CSU/CINDU CUPIDKids)

• Status: Recruiting
• Trial end date: 2024-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals

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:

• 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.