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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). 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.
Primary Outcome
The mMCS is a tool designed to measure disease activity for ulcerative colitis. The mMCS was calculated as the sum of the 3 subscores: stool frequency, rectal bleeding, and endoscopy. Each subscore was graded from 0 to 3 with higher scores indicating more severe disease activity. The total mMCS score ranged from 0 to 9 with higher scores indicating more severe disease activity. The mMCS remission was defined as a total score of score ≤2, with endoscopic subscore of ≤1, stool frequency subscore
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 |
Why NCT05479058 stopped before completion
NCT05479058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05479058 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05479058's enrollment target sits among peer trials
22 1953rd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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