NCT02872285

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Lycera Corp. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Drug: LYC-30937-EC
DRUG	Placebo

Timeline

• Start date: 2016-12-05
• Primary completion: 2017-06-22
• Completion: 2017-06-22
• First posted: 2016-08-19
• Last updated: 2019-04-10
• Results posted: 2019-04-02

Locations

7 sites across 1 country: United States