A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Induction and Maintenance Therapy With PALI-2108 in Participants With Moderately to Severely Active Ulcerative Colitis
Palisade Bio
Summary
The ASCENTRA-UC study is a phase 2 study testing PALI-2108 in patients with moderate to severe ulcerative colitis. Doses of drug will be compared against a placebo to see how well it works, how safe it is, and how the body responds to it.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Documented clinical diagnosis of UC for ≥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence. * If a histopathology report is not available in the source records, a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the screening endoscopy procedure. * Moderately to severely active UC, defined as: * mMS of 5 to 9 (inclusive), AND * ES ≥ 2, AND * RB ≥ 1. * Participants must satisfy at least one of the criteria listed under item a OR at least one of the criteria listed…
Interventions
- DrugPALI-2108
Oral Dose
- DrugPALI-2108
Oral Dose
- DrugPlacebo
Oral Dose
Locations (114)
- Site US-022Sun City, Arizona
- Site US-018San Diego, California
- Site US-028Bristol, Connecticut
- Site US-026Orlando, Florida
- Site US-005Des Plaines, Illinois
- Site US-007Glenview, Illinois