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NCT02057692 · ClinicalTrials.gov registry record · Phase 2
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
A Phase 2 study, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT02057692: Completed Phase 2 study, sponsored by Mirum Pharmaceuticals.
NCT02057692 is a Phase 2 study that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02057692, a Phase 2 study, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.
Primary Outcome
Pruritus was assessed using Itch report outcome measure (ItchRO\[Obs\]), administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). ItchRO(Obs) score ranged from 0 to 4, with the higher score indicating increasing itch severity. The highest score between the morning and evening ItchRO(Obs) reports represented the daily score: a measure of the worst itching over the previous 24-hour period.
Interventions
- DRUG Placebo
- DRUG LUM001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-11-24 |
| Est. Completion | 2016-11-16 |
| Phase | Phase 2 |
What the finished NCT02057692 record still lists
NCT02057692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02057692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02057692 about?
NCT02057692 is a clinical study titled "Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome". The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.
What is the current status of trial NCT02057692?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2014-11-24. Estimated completion is 2016-11-16.
What interventions are being tested in trial NCT02057692?
The interventions under investigation include: Placebo (DRUG), LUM001 (DRUG).
Who is sponsoring clinical trial NCT02057692?
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 NCT02057692's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 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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