NCT05466890

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

Phase 2a, Double-Blind, Randomized Adaptive Design, Placebo-Controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Efficacy, PK and Biomarkers with Oral Colon Delivery PL8177 in Adult Subjects with Active Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Palatin Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study will have potential subjects participating for approximately 4 months: Subjects will be screened to assess their eligibility within 28 days prior to the first dose administration; Day 1 will be eligibility confirmation and in-clinic dosing; additional visits to occur at Weeks 2, 4, 8 and 12. Routine laboratory tests, vital signs and ECG will be measured as well as blood, stool and tissue samples obtained for biomarker and PK studies. Endoscopy is required at screening visit and week 8 visit. Patients will also be given an electronic diary to enter on a daily basis for the duration of their participation. Additional patient questionnaires will be done at clinic visits. Optional genomics testing will also be completed for this study to help look at genes and their effect on inflammation.

Conditions

• Ulcerative Colitis
• Ulcerative Colitis Acute
• Ulcerative
• Ulcerative Colitis Flare

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-02-10
• Completion: 2025-03-31
• First posted: 2022-07-20
• Last updated: 2025-03-05

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study