Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC) (NCT05466890)
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
🩺 Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: Del Sol Research Management, LLC — Tucson, Arizona
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Del Sol Research Management, LLC — Tucson, Arizona
- Gastro Care Institute — Lancaster, California
- Valiance Clinical Research — Tarzana, California
- Advanced Research LLC — Coral Springs, Florida
- IHS Health Research/Gastro Health — Kissimmee, Florida
- Orlando Health, Inc. — Orlando, Florida
- Kansas Gastroenterology — Wichita, Kansas
- Gastroenterology Clinic of Acadiana — Lafayette, Louisiana
- Delta Research Partners — Monroe, Louisiana
- Allied Health Clinical Research Organization, LLC - Englewood — Englewood, New Jersey
- Allied Digestive Health LLC — Freehold, New Jersey
- Allied Health Clinical Research Organization, LLC — Jackson, New Jersey
- Weill Cornell Medicine - Jill Roberts Center for Inflammatory Bowel Disease — New York, New York
- UPMC Presbyterian — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) — Dothan, Alabama
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis — Rochester, Minnesota
Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.