Chronic Spontaneous Urticaria
Conditions
Interventions
Drug: Dupilumab
Pharmaceutical form: Injection solution Subcutaneous
Other Name: Dupixent
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be >= 2 years to 6 consecutive 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
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. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24 [Time Frame baseline:Week 12 and Week 24] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) [Time Frame baseline:Baseline to Week 36] 2. Incidence of anti-drug antibodies (ADA) to dupilumab over time [Time Frame baseline:Baseline to Week 36] 3. Change from baseline in Children's Dermatology Quality Life Index (C-DLQI) in children from 4 years to less than 12 years of age at Week 24 [Time Frame baseline:Baseline to Week 24] The C-DLQI is a validated questionnaire designed to measure the impact of skin disease on children's Health-Related Quality of Life (HRQoL). The questionnaire is validated for children aged >=4 to 30 wheals/24 hours or large confluent areas of wheals). Daily HSS scores are summed over 7-day period to create the HSS7, ranging from 0 to 21. | — |
Countries
Canada, Japan, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed