Chronic Inducible urticaria and Chronic Spontaneous Urticaria
Conditions
Brief summary
Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6, Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores at Week 6
Detailed description
Absolute change from baseline in Urticaria Control test 7 (UCT7) weekly scores at Week 2 and Week 12, Dermatology Life Quality Index (DLQI) response defined as DLQI= 0-1 at Week 2, Week 6 and Week 12, Absolute change from baseline in USDD weekly component scores at Week 2, Week 6 and Week 12; this includes the change in itch, pain and burning NRS from baseline., Safety endpoints will include but not be limited to: • Occurrence of treatment emergent adverse events (AEs) • Occurrence of treatment emergent serious adverse events (SAEs) • Occurrence of treatment emergent adverse events of special interest (AESIs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6, Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores at Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in Urticaria Control test 7 (UCT7) weekly scores at Week 2 and Week 12, Dermatology Life Quality Index (DLQI) response defined as DLQI= 0-1 at Week 2, Week 6 and Week 12, Absolute change from baseline in USDD weekly component scores at Week 2, Week 6 and Week 12; this includes the change in itch, pain and burning NRS from baseline., Safety endpoints will include but not be limited to: • Occurrence of treatment emergent adverse events (AEs) • Occurrence of treatment emergent serious adverse events (SAEs) • Occurrence of treatment emergent adverse events of special interest (AESIs) | — |
Countries
France, Germany, Poland, Spain