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NCT04833855 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT04833855: Completed Phase 2 study, sponsored by Amgen.
NCT04833855 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04833855, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study 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).
Primary Outcome
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) esti
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Omalizumab
- BIOLOGICAL Tezepelumab Dose 1
- BIOLOGICAL Tezepelumab Dose 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2021-04-15 |
| Est. Completion | 2023-04-13 |
| Phase | Phase 2 |
What the finished NCT04833855 record still lists
NCT04833855 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04833855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04833855 about?
NCT04833855 is a clinical study titled "Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria". The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).
What is the current status of trial NCT04833855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2021-04-15. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT04833855?
The interventions under investigation include: Placebo (BIOLOGICAL), Omalizumab (BIOLOGICAL), Tezepelumab Dose 1 (BIOLOGICAL), Tezepelumab Dose 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04833855?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04833855's enrollment target sits among peer trials
183 363rd of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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