CHRONIC SPONTANEOUS URTICARIA
Conditions
Brief summary
Change from baseline in UAS7 at Week 12, Incidence of TEAEs, SAEs, and AEs leading to discontinuation
Detailed description
Change from baseline in UAS7 at all timepoints except Week 12, Change from baseline in ISS7 at Week 12, Change from baseline in HSS7 at Week 12, Achieving complete response defined as UAS7=0 at Week 12, Achieving UAS7 ≤6 at Week 12, Achieving complete response defined as ISS7=0 at Week 12, Achieving complete response defined as HSS7=0 at Week 12, Time to achieving UAS7 ≤6, Time to achieving improvement from baseline ≥10 in UAS7, Incidence of TEAEs, SAEs, and AEs leading to discontinuation
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in UAS7 at Week 12, Incidence of TEAEs, SAEs, and AEs leading to discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in UAS7 at all timepoints except Week 12, Change from baseline in ISS7 at Week 12, Change from baseline in HSS7 at Week 12, Achieving complete response defined as UAS7=0 at Week 12, Achieving UAS7 ≤6 at Week 12, Achieving complete response defined as ISS7=0 at Week 12, Achieving complete response defined as HSS7=0 at Week 12, Time to achieving UAS7 ≤6, Time to achieving improvement from baseline ≥10 in UAS7, Incidence of TEAEs, SAEs, and AEs leading to discontinuation | — |
Outcome results
None listed