NCT02762500

An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Lycera Corp. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.

Detailed description

Approximately 120 subjects will be randomized to receive either enteric-coated (EC) LYC-30937-EC 25 mg PO once daily (QD) or matching placebo PO QD for the duration of 8 weeks. Randomization will be stratified based on previous exposure to anti-tumor necrosis factor (TNF) agents such that at least 50% of the randomized subjects will be anti-TNF naïve . The study will consist of 3 phases: * screening phase: up to 4 weeks * double-blind placebo-controlled phase treatment: 8 weeks * post-treatment follow-up: 2 weeks Eligible subjects will be randomized at Week 0 (Study Day 1) to either LYC-30937-EC 25 mg or placebo. Screening will occur from Study Days -28 to -1. Randomization and first dosing will occur at Week 0/Study Day 1. Double-blind study visits will occur at Weeks 2, 4, and 8, with the last dose at Week 8/Study Day 57. Subjects will return at Week 10 for a post-treatment safety follow-up visit.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	LYC-30937-EC
DRUG	Placebo

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2016-05-05
• Last updated: 2019-04-02
• Results posted: 2019-04-02

Locations

71 sites across 7 countries: United States, Canada, Czechia, Hungary, Netherlands, Poland, Serbia