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

NCT00539929 | Completed Phase 2

• 1 other identifier: E6201-A001-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Total Symptom Severity (TSS) at week 8.

  8 weeks

Secondary Outcomes (1)

• Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)

  Up to 12 weeks

Study Arms (4)

E6201 0.005% BID

EXPERIMENTAL

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: E6201 0.005%; Drug: Placebo

E6201 0.01% BID

EXPERIMENTAL

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: E6201 0.01%; Drug: Placebo

E6201 0.03% BID

EXPERIMENTAL

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: E6201 0.03%; Drug: Placebo

E6201 0.03% QD

EXPERIMENTAL

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: E6201 0.03%; Drug: Placebo

Interventions

E6201 0.005% DRUG

E6201 0.005% BID

E6201 0.01% DRUG

E6201 0.01% BID

E6201 0.03% DRUG

E6201 0.03% BID; E6201 0.03% QD

Placebo DRUG

E6201 0.005% BID; E6201 0.01% BID; E6201 0.03% BID; E6201 0.03% QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (12)

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Boise, Idaho, United States

Location

Unknown Facility

Champaign, Illinois, United States

Location

Unknown Facility

Clinton Township, Michigan, United States

Location

Unknown Facility

Fridley, Minnesota, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Carlstadt, New Jersey, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

College Station, Texas, United States

Location

Unknown Facility

Lynchburg, Virginia, United States

Location

Study Officials

• Eisai US Medical Services

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 5, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 6, 2017

Record last verified: 2017-01

Locations

US (12)