PL-8177 for Ulcerative Colitis

(PL8177-205 Trial)

Not currently recruiting at 21 trial locations

Overseen By Nazish Huq, Director Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Palatin Technologies, Inc

Must be taking: 5-ASA

Must not be taking: NSAIDs, Anticoagulants, Biologics, others

Disqualifiers: Crohn's, Cancer, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new medication, PL8177, to determine its effectiveness in treating ulcerative colitis (UC), a condition that causes inflammation in the intestines. Participants will receive either the actual medication or a placebo (a pill with no active medicine) for eight weeks. The study will assess whether PL8177 is safe, how well the body tolerates it, and if it aids in healing the intestines. This trial may suit adults diagnosed with active UC who manage it with medications like 5-ASA, a common UC treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications to join the trial. For example, if you are taking 5-ASA, you must have been on a stable dose for at least 3 weeks before the screening. Other medications like thiopurines, oral corticosteroids, and certain biologics must be stopped for a specified period before the trial.

Is there any evidence suggesting that PL8177 is likely to be safe for humans?

Research has shown that PL8177 is generally safe based on previous studies. In one study, 33% of patients taking PL8177 achieved clinical remission after eight weeks, while none of the patients taking a placebo did. This suggests that the treatment works for some people without major safety concerns. Animal studies, such as those in rats, have also shown that PL8177 reduces damage and improves symptoms in ulcerative colitis.

These findings indicate that PL8177 appears safe so far. However, as this is a phase 2 study, more information is needed to confirm its long-term safety. Prospective participants should discuss all possible risks and benefits with a healthcare professional before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Ulcerative Colitis?

Most treatments for ulcerative colitis involve suppressing inflammation with medications like corticosteroids or biologics that target specific parts of the immune system. But PL8177 works differently, targeting the melanocortin system, which is a novel approach in this field. Researchers are excited because PL8177 is administered orally, potentially making it more convenient for patients compared to injectable treatments. Additionally, its unique mechanism might offer benefits for those who don't respond well to existing therapies.

What evidence suggests that PL8177 might be an effective treatment for Ulcerative Colitis?

Research has shown that PL8177, which participants in this trial may receive, might help treat ulcerative colitis. In an earlier study, 33% of patients taking PL8177 experienced significant improvement in their symptoms after eight weeks, reaching clinical remission. In contrast, none of the patients taking a placebo, a harmless pill with no active medicine, saw this level of improvement. Additionally, animal studies found that PL8177 reduced colon damage and improved stool consistency. These results suggest that PL8177 may help heal the intestines and reduce symptoms of ulcerative colitis. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert Jordan, VP Clinical Operations

Principal Investigator

Telephone: [phone]; Email: [e-mail]

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

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

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?

Group I: PL8177 Experimental Treatment 1 Intervention

PL8177 will be given orally and daily from baseline until end of study.

Group II: Placebo Placebo Group 1 Intervention

Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.

Who Is Running the Clinical Trial?

Palatin Technologies, Inc

Lead Sponsor

Trials

12

Recruited

3,000+

Citations

1. palatin.com palatin.com/press_releases/palatin-announces-positive-topline-results-from-phase-2-ulcerative-colitis-uc-study-of-oral-melanocortin-1-receptor-agonist-pl8177/

Palatin Announces Positive Topline Results from Phase 2 ... Clinical Remission: Achieved in 33% of PL8177-treated patients versus 0% on placebo after eight weeks of treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05466890?term=AREA%5BConditionSearch%5D(Ulcerative%20Colitis)&rank=2

NCT05466890 | Phase 2a to Evaluate PL-8177 in Subjects ... 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 ...

3. journals.lww.com journals.lww.com/10.14309/01.ajg.0001135636.77486.bc

S2044 Safety, Tolerability, and Efficacy of PL8177 in... In a rat model of ulcerative colitis (UC), PL8177 reduced colonic macroscopic damage, fecal occult blood, and colon weight and improved stool consistency. Here, ...

4. prnewswire.com prnewswire.com/news-releases/palatin-announces-positive-topline-results-from-phase-2-ulcerative-colitis-uc-study-of-oral-melanocortin-1-receptor-agonist-pl8177-302413472.html

Palatin Announces Positive Topline Results from Phase 2 ... Clinical Remission: Achieved in 33% of PL8177-treated patients versus 0% on placebo after eight weeks of treatment.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36891301/

A novel oral formulation of the melanocortin-1 receptor ... Results: Rats treated with 50 µg oral PL8177 demonstrated significantly lower macroscopic colon damage scores and improvement in colon weight, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S001650852305254X

A MELANOCORTIN RECEPTOR AGONIST PL8177 Transcriptomics and proteomics data show that oral PL8177 treatment causes diseased colons to move toward the healthy state and to resolve inflammation.