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NCT02061540 · ClinicalTrials.gov registry record · Phase 2
Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis
A Phase 2 study, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT02061540: Completed Phase 2 study, sponsored by Mirum Pharmaceuticals.
NCT02061540 is a Phase 2 study that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02061540, a Phase 2 study, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.
Primary Outcome
An Adverse Event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. TEAEs were AEs with a start date on or after the first dose of investigational product and started prior to the last dose of investigational product plus 14 days.
Interventions
- DRUG LUM001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT02061540 record still lists
NCT02061540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which LUM001 is the first listed.
NCT02061540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02061540 about?
NCT02061540 is a clinical study titled "Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis". The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.
What is the current status of trial NCT02061540?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2014-03. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02061540?
The interventions under investigation include: LUM001 (DRUG).
Who is sponsoring clinical trial NCT02061540?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02061540's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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