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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion (week 12).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion (week 12).
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer within the last 5 years.I agree to use effective birth control during and 30 days after the study.My ulcerative colitis is currently active.I have a history of mitochondrial disorder.I am taking or will take a proton pump inhibitor during the study.I stopped taking thiopurine medication more than 4 weeks ago.I am between 18 and 75 years old.I have an ileostomy or colostomy, or I've had part of my colon removed.I have colon polyps that haven't been removed.I am taking 5-ASA with a specific dose and duration before my screening test.I have a serious health condition affecting my nerves, mind, eyes, lungs, heart, stomach (not including ulcerative colitis), liver, kidneys, hormones, or another major system.I have or had Crohn's disease or similar conditions.I am not taking any medications that are not allowed in the study.I have not had a menstrual period for at least 12 months and my blood test confirms I am postmenopausal.I have previously been treated with PL8177.I stopped taking oral steroids at least 4 weeks before my screening test.My disease extends at least 5 cm up from the start of my anal canal.I understand and can follow the study's requirements and visit schedule.I have not taken any anti-diarrheal medication in the last 48 hours.I haven't had a serious infection or needed IV antibiotics in the last 4 weeks.I have a planned hospital stay or surgery during the study period.My ulcerative colitis diagnosis was confirmed through a scope and tissue tests.I haven't started or changed the dose of any prescription drugs or supplements recently.I have severe colon issues, active stomach ulcers, cervical dysplasia, or primary sclerosing cholangitis.I am between 18 and 75 years old.I have been on a stable dose of 5-ASA medication for at least 3 weeks.I have active ulcerative colitis with significant inflammation.Women who can become pregnant must have a negative pregnancy test before starting the study.I stopped taking 5-ASA at least 3 weeks before my screening endoscopy.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: PL8177
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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