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NCT03693625 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
A Phase 2 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT03693625: Clinical Trial Phase 2 study, sponsored by Genentech.
NCT03693625 is a Phase 2 study that was terminated before completion, run by Genentech. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03693625, a Phase 2 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a fenebrutinib CSU parent study. Participants may enroll in this OLE study at any time after completing the treatment period of the parent study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg) orally twice a day. Treatment may continue until the end of the study.
Primary Outcome
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisti
Interventions
- DRUG GDC-0853
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 2 |
Why NCT03693625 stopped before completion
NCT03693625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which GDC-0853 is the first listed.
NCT03693625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03693625 about?
NCT03693625 is a clinical study titled "A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study". This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a fenebrutinib CSU parent study. Participants may enroll in this OLE stu...
What is the current status of trial NCT03693625?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2018-09-27. Estimated completion is 2019-10-23.
What interventions are being tested in trial NCT03693625?
The interventions under investigation include: GDC-0853 (DRUG).
Who is sponsoring clinical trial NCT03693625?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03693625's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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