Chronic Inducible Urticaria
Conditions
Brief summary
Incidence and severity of treatment emergent AEs/SAEs, Laboratory assessments, ECG, vital signs, Supervision of expected AEs: Taste change assessments Hair color change assessment
Detailed description
Provocation testing: ColdU: Critical temperature threshold (CCT) SD: Critical friction threshold (CFT), Urticaria Control Test (UCT), Complete response rate: Proportion of participants who are urticaria free based on UCT = 16, Well-controlled rate: Proportion of participants who are well controlled based on UCT ≥ 12, Time to complete response or well-controlled disease, Time to relapse, Serum PK concentration of briquilimab over time - Modelled serum PK parameters of briquilimab including but not limited to Cmax, Cmin and AUC as appropriate
Interventions
DRUGEPINEPHRINE
DRUGBriquilimab
Sponsors
Jasper Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment emergent AEs/SAEs, Laboratory assessments, ECG, vital signs, Supervision of expected AEs: Taste change assessments Hair color change assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Provocation testing: ColdU: Critical temperature threshold (CCT) SD: Critical friction threshold (CFT), Urticaria Control Test (UCT), Complete response rate: Proportion of participants who are urticaria free based on UCT = 16, Well-controlled rate: Proportion of participants who are well controlled based on UCT ≥ 12, Time to complete response or well-controlled disease, Time to relapse, Serum PK concentration of briquilimab over time - Modelled serum PK parameters of briquilimab including but not limited to Cmax, Cmin and AUC as appropriate | — |
Countries
Germany
Outcome results
None listed