16 Participants Needed

PL-8177 for Ulcerative Colitis

(PL8177-205 Trial)

Recruiting at 21 trial locations
RJ
NH
Overseen ByNazish Huq, Director Clinical Operations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Palatin Technologies, Inc
Must be taking: 5-ASA
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

RJ

Robert Jordan, VP Clinical Operations

Principal Investigator

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

Are You a Good Fit for This Trial?

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.
Has provided informed consent prior to initiation of any study specific activities/procedures
See 6 more

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
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive PL8177 or placebo for 8 weeks to evaluate safety, tolerability, and efficacy

8 weeks
Visits at Weeks 2, 4, and 8 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Visit at Week 12 (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • PL8177
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PL8177Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Palatin Technologies, Inc

Lead Sponsor

Trials
12
Recruited
3,000+
Unbiased ResultsWe believe in providing patients with all the options.
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