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NCT05479058 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
A Phase 3 study, sponsored by Lakefront Biotherapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 22
- Enrollment target
NCT05479058: Clinical Trial Phase 3 study, sponsored by Lakefront Biotherapeutics.
NCT05479058 is a Phase 3 study that was terminated before completion, run by Lakefront Biotherapeutics. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05479058, a Phase 3 study, was terminated before completion, sponsored by Lakefront Biotherapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 22 participants
- Enrollment target
Study Summary
Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.
Interventions
- DRUG Placebo
- DRUG Filgotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2023-10-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05479058
The ClinicalTrials.gov registry entry for NCT05479058 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lakefront Biotherapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05479058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05479058 about?
NCT05479058 is a clinical study titled "A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission". Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was t...
What is the current status of trial NCT05479058?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2022-07-26. Estimated completion is 2023-10-09.
What interventions are being tested in trial NCT05479058?
The interventions under investigation include: Placebo (DRUG), Filgotinib (DRUG).
Who is sponsoring clinical trial NCT05479058?
This trial is sponsored by Lakefront Biotherapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
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