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

Colitis, Ulcerative Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

• NCT number: NCT02762500
• Study type: Interventional
• Source: Lycera Corp.
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Completion date: May 2018