Chronic Inducible Urticaria
Conditions
Brief summary
Proportion (%) of patients with a negative provocation test at Week 12 in the ColdU subtype cohort (X) For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®, Proportion (%) of patients with a negative provocation test at Week 12 in the SD subtype cohort (X) For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
Detailed description
Mean change from baseline to Week 12 in CTT in the ColdU subtype cohort, Mean change from baseline to Week 12 in CFT in the SD subtype cohort, Mean change from baseline to Week 12 in WI-NRSprovo in the ColdU subtype cohort, Mean change from baseline to Week 12 in WI-NRSprovo in the SD subtype cohort, Proportion (%) of patients with a negative provocation test at Week 12 in the combined CIndU subtype cohorts, Mean change from baseline to Week 12 in WI-NRSprovo in the combined CIndU subtype cohorts, Proportion (%) of patients experiencing TEAEs over the 20-week treatment period by subtype cohort and in the combined CIndU subtype cohorts
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of patients with a negative provocation test at Week 12 in the ColdU subtype cohort (X) For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®, Proportion (%) of patients with a negative provocation test at Week 12 in the SD subtype cohort (X) For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest® | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to Week 12 in CTT in the ColdU subtype cohort, Mean change from baseline to Week 12 in CFT in the SD subtype cohort, Mean change from baseline to Week 12 in WI-NRSprovo in the ColdU subtype cohort, Mean change from baseline to Week 12 in WI-NRSprovo in the SD subtype cohort, Proportion (%) of patients with a negative provocation test at Week 12 in the combined CIndU subtype cohorts, Mean change from baseline to Week 12 in WI-NRSprovo in the combined CIndU subtype cohorts, Proportion (%) of patients experiencing TEAEs over the 20-week treatment period by subtype cohort and in the combined CIndU subtype cohorts | — |
Countries
Bulgaria, Germany, Hungary, Latvia, Lithuania, Poland, Spain