Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04833855 | Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria | PHASE2 | COMPLETED | 183 | — | — | Apr 15, 2021 | Apr 13, 2023 | Apr 9, 2025 | 81 | United States, Canada +8 |
The UAS is a CSU-specific patient-reported outcome measure with 2 components: Hives Severity Score (HSS) for number of wheals and an Itch Severity Score (ISS) for itch intensity, and are each scored from 0 (no wheals, no itch) to 3 (\>50 wheals, severe itch) for the previous 24 hours. The HSS and ISS are combined to give a daily UAS ranging from 0 to 6. The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). The least squares mean (LSM) estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity.
| Arm | Type | Description |
|---|---|---|
| Group 1: Omalizumab | ACTIVE_COMPARATOR | Participants naive to anti-IgE therapies will receive omalizumab. |
| Group 2: Placebo | PLACEBO_COMPARATOR | Participants naive to anti-IgE therapies will receive a placebo. |
| Group 3: Tezepelumab Dose 1 | EXPERIMENTAL | Participants naive to anti-IgE therapies will receive tezepelumab. |
| Group 4: Tezepelumab Dose 2 | EXPERIMENTAL | Participants naive to anti-IgE therapies will receive tezepelumab. |
| Group 5: Placebo | PLACEBO_COMPARATOR | Participants previously treated with anti-IgE therapies will receive a placebo. |
| Group 6: Tezepelumab Dose 1 | EXPERIMENTAL | Participants previously treated with anti-IgE therapies will receive tezepelumab. |
| Group 7: Tezepelumab Dose 2 | EXPERIMENTAL | Participants previously treated with anti-IgE therapies will receive tezepelumab. |
| Name | Type | Description |
|---|---|---|
| Tezepelumab Dose 1 | BIOLOGICAL | Subcutaneous injection. |
| Tezepelumab Dose 2 | BIOLOGICAL | Subcutaneous injection. |
| Omalizumab | BIOLOGICAL | Subcutaneous injection. |
| Placebo | BIOLOGICAL | Subcutaneous injection. |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male and female participants ≥ 18 years and ≤ 80 years of age at the time of screening. * Chronic spontaneous urticaria (CSU) diagnosis for ≥ 6 months at the time of screening. * CSU inadequately c...