An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis

Psoriasis Clinical Trial

Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of LYC-30937-EC in Subjects With Moderate Chronic Plaque-Type Psoriasis

Status Completed

Clinical Trial Summary

The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC in patients with moderate plaque-type psoriasis.

Clinical Trial Description

Approximately 30 subjects will be enrolled in this double-blind, placebo-controlled study. The randomization will be stratified 2:1 into the LYC-30937-EC cohort (2) or the placebo cohort (1). The active cohort will receive LYC-30937-EC 25 mg once daily, which demonstrated safety and tolerability in Phase I trials.

The study is designed for patients with previously diagnosed moderate chronic plaque-type psoriasis and consists of the following:

• Screening period (initials assessment and eligibility scoring)

• Day 1: confirm eligibility, baseline efficacy assessments (PASI, IGA), randomize and initiate dosing

• Week 2: safety assessments including vital signs, body temperature, physical exam, clinical labs will be performed

• Week 4: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed

• Week 8: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed

• Week 12: final efficacy assessments (PASI, IGA), safety assessments including vital signs, body temperature, physical exam, ECG, and clinical labs will be performed

• Week 14: final safety assessments including vital signs, body temperature, and clinical labs ;

Related Conditions & MeSH terms

• Psoriasis

• NCT number: NCT02872285
• Study type: Interventional
• Source: Lycera Corp.
• Status: Completed
• Phase: Phase 2
• Start date: December 5, 2016
• Completion date: June 22, 2017