Chronic Inducible Urticaria and Chronic Spontaneous Urticaria
Conditions
Brief summary
Part A/B: Overall safety profile as assessed by the type, frequency, severity, and causality of Adverse Events
Detailed description
1. Part A: Cold-induced urticaria: mean change in critical temperature threshold using TempTest from Baseline to the end of Week 12, 2. Part A: Symptomatic dermographism: mean change in total Fric score using FricTest from Baseline to the end of Week 12, 3. Part A: Complete response rate at the end of Week 12, 4. Part B: Mean change from Baseline to the end of Week 12 in patient reported outcome(s), 5. Part B: Complete response rate at the end of Week 12, 6. Part A/B: Absolute and percent change in pharmacodynamic markers from Baseline to the end of Week 12, 7. Part A/B: Population pharmacokinetic parameters including but not limited to AUC, Cmax, Cmin, CL/F, Vc/F, and t1/2
Sponsors
Blueprint Medicines Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A/B: Overall safety profile as assessed by the type, frequency, severity, and causality of Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Part A: Cold-induced urticaria: mean change in critical temperature threshold using TempTest from Baseline to the end of Week 12, 2. Part A: Symptomatic dermographism: mean change in total Fric score using FricTest from Baseline to the end of Week 12, 3. Part A: Complete response rate at the end of Week 12, 4. Part B: Mean change from Baseline to the end of Week 12 in patient reported outcome(s), 5. Part B: Complete response rate at the end of Week 12, 6. Part A/B: Absolute and percent change in pharmacodynamic markers from Baseline to the end of Week 12, 7. Part A/B: Population pharmacokinetic parameters including but not limited to AUC, Cmax, Cmin, CL/F, Vc/F, and t1/2 | — |
Countries
Denmark, Germany, Italy, Spain
Outcome results
None listed