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Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)

NCT05466890 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-03-05

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

PL8177 Placebo

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

DRUG

PL8177

Approximately 3/4 of randomized patients will receive active PL8177.

Sponsors & Collaborators

  • Palatin Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • Robert Jordan, VP Clinical Operations · Telephone: 609-598-1786; Email: [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2025-02-10
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05466890 on ClinicalTrials.gov