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

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Palatin Technologies, Inc

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Robert Jordan, VP Clinical Operations

Principal Investigator

Telephone: 609-598-1786; Email: rjordan@palatin.com

Eligibility Criteria

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.

Inclusion Criteria

I agree to use effective birth control during and 30 days after the study.

My ulcerative colitis is currently active.

I am between 18 and 75 years old.

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Exclusion Criteria

I have had cancer within the last 5 years.

Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device)

Clinically significant findings on 12-lead ECG

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Treatment Details

Interventions

PL8177 (Melanocortin receptor agonist)
Placebo (Drug)

Trial OverviewThe 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.

Participant Groups

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.