Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis

Proof of Principle, Randomized, Parallel-Group, Double-Blind, Vehicle-Controlled, Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis

This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment. Pharmacokinetic samples will be obtained pre-and post treatment.

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: E6201 0.005%; Drug: E6201 0.01%; Drug: E6201 0.03%

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States
  • California
    • San Diego, California, United States
  • Idaho
    • Boise, Idaho, United States
  • Illinois
    • Champaign, Illinois, United States
  • Michigan
    • Clinton Township, Michigan, United States
  • Minnesota
    • Fridley, Minnesota, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Jersey
    • Carlstadt, New Jersey, United States
  • Oregon
    • Portland, Oregon, United States
  • Texas
    • Austin, Texas, United States
    • College Station, Texas, United States
  • Virginia
    • Lynchburg, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• Males and females 18 years or older with a clinical diagnosis of mild-to-moderate plaque-type psoriasis for ≥12 months prior to screening
• Female participants postmenopausal >1 year or surgically sterile
• Two representative and similar target lesions for the condition, each of 15-25 centimeters squared (cm^2), up to 50 cm^2 in surface area
• Target lesion severity score of 4-8 on a scale of 0 to 12, where, in the opinion of the Investigator, 0 equals no evidence of disease and 12 equals severe induration, erythema, scaling, and pruritus
• Prescription medications, if applicable, for chronic conditions allowed but must be on a stable regimen prior to and during the study; this is also applicable for dietary supplements and over-the-counter (OTC) drugs
• Participants able and willing to give informed consent

EXCLUSION CRITERIA

• Use of any, concomitant, topical treatment for psoriasis, excluding emollients
• Use of any, concomitant, systemic treatment for psoriasis, including ultraviolet radiation (UVR) light
• Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, musculoskeletal, rheumatologic, or cardiovascular system abnormalities
• Evidence of any clinically significant deviation from normal with respect to medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations. If any participant has an abnormal clinical laboratory test finding that meets specified criteria, that participant will be re-tested by repeated blood draw and clinical laboratory assessment. If the abnormal test finding is confirmed, the participant will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E6201 0.005% BID; Participants applied E6201 0.005% cream to a pre-identified marker lesion twice a day (BID) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.	Drug: Placebo; Drug: E6201 0.005%
Experimental: E6201 0.01% BID; Participants applied E6201 0.01% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.	Drug: Placebo; Drug: E6201 0.01%
Experimental: E6201 0.03% BID; Participants applied E6201 0.03% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.	Drug: Placebo; Drug: E6201 0.03%
Experimental: E6201 0.03% QD; Participants applied E6201 0.03% cream to a pre-identified marker lesion once a day (QD) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.	Drug: Placebo; Drug: E6201 0.03%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Symptom Severity (TSS) at week 8.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Study Director: Eisai US Medical Services, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: October 3, 2007
• First Submitted That Met QC Criteria: October 3, 2007
• First Posted (Estimate): October 5, 2007

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: E6201-A001-201