Chronic Urticaria
Conditions
Brief summary
Incidence and severity of adverse events (AEs) including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) and adverse events of interest (AEIs). Physical examination findings and standard clinical laboratory parameters.
Detailed description
Chronic inducible urticaria {CIndU}: - Change from baseline in critical temperature threshold (CCT) and critical friction threshold (CFT) over time. - Change from Baseline in urticaria control test (UCT) over time. - Percentage of participants with complete response and well-controlled disease over time., Chronic spontaneous urticaria {CSU}: - Change from baseline in urticaria activity score over 7 days (UAS7), hive severity score over 7 days (HSS7), itch severity score over 7 days (ISS7), and uricaria control test (UCT) over time. - Percentage of participants with complete response and well-controlled disease over time.
Interventions
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 adverse events (AEs) including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) and adverse events of interest (AEIs). Physical examination findings and standard clinical laboratory parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic inducible urticaria {CIndU}: - Change from baseline in critical temperature threshold (CCT) and critical friction threshold (CFT) over time. - Change from Baseline in urticaria control test (UCT) over time. - Percentage of participants with complete response and well-controlled disease over time., Chronic spontaneous urticaria {CSU}: - Change from baseline in urticaria activity score over 7 days (UAS7), hive severity score over 7 days (HSS7), itch severity score over 7 days (ISS7), and uricaria control test (UCT) over time. - Percentage of participants with complete response and well-controlled disease over time. | — |
Countries
Germany
Outcome results
None listed