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NCT05466890 · ClinicalTrials.gov registry record · Phase 2
Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)
A Phase 2 study of Ulcerative Colitis and Ulcerative Colitis Acute, sponsored by Palatin Technologies.
- Active
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 14
- Study locations
NCT05466890: Active Phase 2 study of Ulcerative Colitis and Ulcerative Colitis Acute, sponsored by Palatin Technologies.
NCT05466890 is a Phase 2 study of Ulcerative Colitis and Ulcerative Colitis Acute that is active but no longer recruiting, run by Palatin Technologies. The registered enrollment target is 16 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05466890, a Phase 2 study of Ulcerative Colitis and Ulcerative Colitis Acute, is active but no longer recruiting, sponsored by Palatin Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).
Primary Outcome
Adverse events (AEs) will be collected from the time of signing the informed consent form (ICF). All subjects who are randomized will be monitored for AEs until the time they leave the study.
Conditions Studied
Interventions
- DRUG PL8177 Placebo
- DRUG PL8177
Study Locations (14)
Florida
- Advanced Research LLC - Coral Springs
- IHS Health Research/Gastro Health - Kissimmee
- Orlando Health, Inc. - Orlando
New Jersey
- Allied Health Clinical Research Organization, LLC - Englewood - Englewood
- Allied Digestive Health LLC - Freehold
- Allied Health Clinical Research Organization, LLC - Jackson
California
- Gastro Care Institute - Lancaster
- Valiance Clinical Research - Tarzana
Louisiana
- Gastroenterology Clinic of Acadiana - Lafayette
- Delta Research Partners - Monroe
Arizona
- Del Sol Research Management, LLC - Tucson
Kansas
- Kansas Gastroenterology - Wichita
New York
- Weill Cornell Medicine - Jill Roberts Center for Inflammatory Bowel Disease - New York
Pennsylvania
- UPMC Presbyterian - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
What the registry record for NCT05466890 still lists
NCT05466890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which PL8177 Placebo is the first listed.
NCT05466890 lists 14 locations in 8 states (Florida, New Jersey, California).
Frequently Asked Questions
What is clinical trial NCT05466890 about?
NCT05466890 is a clinical study titled "Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)". The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8...
What is the current status of trial NCT05466890?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2022-09-15. Estimated completion is 2025-03-31.
What conditions does trial NCT05466890 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Ulcerative Colitis Acute, Ulcerative, Ulcerative Colitis Flare.
What interventions are being tested in trial NCT05466890?
The interventions under investigation include: PL8177 Placebo (DRUG), PL8177 (DRUG).
Who is sponsoring clinical trial NCT05466890?
This trial is sponsored by Palatin Technologies, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05466890 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05466890's enrollment target sits among peer trials
16 118th of 122 higher than 5 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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.
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