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NCT04159701 · ClinicalTrials.gov registry record · Phase 2
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
A Phase 2 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT04159701: Clinical Trial Phase 2 study, sponsored by Eli Lilly and Company.
NCT04159701 is a Phase 2 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04159701, a Phase 2 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.
Primary Outcome
The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment perio
Interventions
- DRUG Placebo
- DRUG LY3454738
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2021-02-24 |
| Phase | Phase 2 |
Why NCT04159701 stopped before completion
NCT04159701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04159701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04159701 about?
NCT04159701 is a clinical study titled "A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria". The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.
What is the current status of trial NCT04159701?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2019-11-15. Estimated completion is 2021-02-24.
What interventions are being tested in trial NCT04159701?
The interventions under investigation include: Placebo (DRUG), LY3454738 (DRUG).
Who is sponsoring clinical trial NCT04159701?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04159701's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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