Trials / Completed
CompletedNCT04833855
Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 183 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tezepelumab Dose 1 | Subcutaneous injection. |
| BIOLOGICAL | Tezepelumab Dose 2 | Subcutaneous injection. |
| BIOLOGICAL | Omalizumab | Subcutaneous injection. |
| BIOLOGICAL | Placebo | Subcutaneous injection. |
Timeline
- Start date
- 2021-04-15
- Primary completion
- 2022-12-20
- Completion
- 2023-04-13
- First posted
- 2021-04-06
- Last updated
- 2025-04-09
- Results posted
- 2024-05-01
Locations
81 sites across 10 countries: United States, Canada, France, Germany, Greece, Italy, Japan, Poland, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04833855. Inclusion in this directory is not an endorsement.