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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
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.
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
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Lycera Investigational Site
Carmel, Indiana, United States
Lycera Investigational Site
Andover, Massachusetts, United States
Lycera Investigational Site
Fridley, Minnesota, United States
Lycera Investigational Site
East Windsor, New Jersey, United States
Lycera Investigational Site
High Point, North Carolina, United States
Lycera Investigational Site
Broomall, Pennsylvania, United States
Lycera Investigational Site
Norfolk, Virginia, United States
Start Date
December 5, 2016
Primary Completion Date
June 22, 2017
Completion Date
June 22, 2017
Last Updated
April 10, 2019
33
ACTUAL participants
Drug: LYC-30937-EC
DRUG
Placebo
DRUG
Lead Sponsor
Lycera Corp.
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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