NCT05466890Phase 2Active not recruiting

Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)

Study sponsor: Palatin Technologies, Inc · PTN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-02-10Actual

Enrollment · participants16Estimated

Source updated2025-03-05Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Ulcerative Colitis; Ulcerative Colitis Acute; Ulcerative; Ulcerative Colitis Flare

Treatments or interventions studied

PL8177 PlaceboDrugAlso known as Placebo
PL8177DrugAlso known as Active study medication

Primary outcomes · main study measures

Read the study measures

measure: To evaluate the safety and tolerability of PL8177 compared to placebo in patients with active UC.; description: 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.; timeFrame: Baseline through Study Completion (Week 12).; measure: To compare the proportion of subjects achieving Mayo Endoscopic Subscore of ≤ 1 point (0 or 1) between PL8177 and placebo after 8 weeks of treatment.; description: Efficacy will be determined through the use of the Mayo Endoscopic Subscore.; timeFrame: Time Frame: Mayo Endoscopic Subscore will be evaluated at Week 8.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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