Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tezepelumab Dose 1 · 1 trial · 1 indication
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...
Tezepelumab is an investigational monoclonal antibody being studied for chronic spontaneous urticaria, asthma, and atopic dermatitis. It has also been evaluated in healthy volunteers. Tezepelumab is not approved and remains in clinical development.
Tezepelumab is being developed by Amgen Inc. (NASDAQ: AMGN). The company has sponsored clinical trials of the drug across multiple indications, including asthma, atopic dermatitis, and chronic spontaneous urticaria.
Tezepelumab is in clinical development. It has completed Phase 1 trials in healthy volunteers, atopic dermatitis, and asthma, and a Phase 2 trial in chronic spontaneous urticaria. Tezepelumab is investigational and not FDA approved.
Tezepelumab has been studied in several completed trials: NCT00757042 in atopic dermatitis and healthy volunteers, NCT00972179 in healthy adults, NCT01405963 in mild atopic asthma, and NCT04833855 in chronic spontaneous urticaria. The chronic spontaneous urticaria trial enrolled 183 participants.
Yes, Tezepelumab is also known as AMG 157. Clinical trial records refer to the drug as Tezepelumab (AMG 157), confirming that both names identify the same investigational monoclonal antibody.