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Melanocortin receptor agonist

PL-8177 for Ulcerative Colitis (PL8177-205 Trial)

Phase 2
Recruiting
Research Sponsored by Palatin Technologies, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (week 12).

Summary

This trial is testing a new drug for ulcerative colitis. Patients will take it once a day for 8 weeks, then there will be a 4-week follow-up period.

Who is the study for?
Adults aged 18-75 with active Ulcerative Colitis (UC) for at least 6 months, confirmed by endoscopy and fecal calprotectin levels. Participants must not have had certain UC treatments recently, agree to contraception if of childbearing potential, and cannot have a history of significant other diseases or colon surgery.
What is being tested?
The trial is testing PL8177 against a placebo in adults with acute UC. For every three participants receiving PL8177, one will get a placebo. The treatment lasts for 8 weeks and aims to assess safety, how the body processes the drug, and its effect on intestinal healing.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with new drugs may include nausea, headaches, allergic reactions or injection site discomfort. Safety monitoring will track any adverse effects from PL8177 during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion (week 12).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion (week 12). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
To evaluate the safety and tolerability of PL8177 compared to placebo inpatients with active UC.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PL8177Experimental Treatment1 Intervention
PL8177 will be given orally and daily from baseline until end of study.
Group II: PlaceboPlacebo Group1 Intervention
Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.

Find a Location

Who is running the clinical trial?

Palatin Technologies, IncLead Sponsor
11 Previous Clinical Trials
2,936 Total Patients Enrolled
Robert JordanStudy DirectorPalatin
5 Previous Clinical Trials
1,534 Total Patients Enrolled
Robert Jordan, VP Clinical OperationsStudy DirectorTelephone: 609-598-1786; Email: rjordan@palatin.com

Media Library

PL8177 (Melanocortin receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05466890 — Phase 2
Flare Up Research Study Groups: Placebo, PL8177
Flare Up Clinical Trial 2023: PL8177 Highlights & Side Effects. Trial Name: NCT05466890 — Phase 2
PL8177 (Melanocortin receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05466890 — Phase 2
~9 spots leftby Nov 2025