A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris

NCT01268527 | Completed Phase 2 Results

• 2 other identifiers: E6201-E044-2042009-014815-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of E6201 in subjects with psoriasis vulgaris.

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis vulgaris

Outcome Measures

Primary Outcomes (1)

• Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate

  The AUC was based on the baseline-corrected thickness of the psoriatic infiltrate (20 megahertz (MHz) Sonographic measurement) at specified days for each treatment field calculated by applying the linear trapezoidal rule. Sonographic measurements were performed using a 20 MHz high-frequency sonograph. Serial A-scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore, exact measurement of skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent band below the entrance echo. The thickness of the echo lucent psoriatic band was determined. The thickness was measured in micrometers (um) and was denoted as T.

  Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment)

Secondary Outcomes (5)

• Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation)

  Day 12/Discontinuation (Visit 14/End of Treatment)

• Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8

  Day 8 (Visit 10)

• Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation

  Day 12/Discontinuation (Visit 14/End of Treatment)

• Clinical (Global) Assessment of Efficacy on Day 8

  Day 8 (Visit 10)

• Overview of Treatment-Emergent Adverse Events (TEAEs)

  From first dose of study treatment up to 30 days after the last dose, or until resolution, whichever came first, or up to approximately 10 months.

Study Arms (2)

Cohort 1

EXPERIMENTAL

Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior to dosing in Cohort 2.

Drug: 0.03% E6201; Drug: 0.1% E6201; Drug: 0.2% E6201; Other: Placebo - 0.03% gel vehicle; Other: Placebo - 0.1% gel vehicle; Other: Placebo - 0.2% gel vehicle; Drug: Calcipotriene

Cohort 2

EXPERIMENTAL

Three concentrations of E6201 topical gel (0.005%, 0.01%, and 0.05%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated.

Drug: 0.005% E6201; Drug: 0.01% E6201; Drug: 0.05% E6201; Other: Placebo - 0.05% gel vehicle; Other: Placebo - 0.01% gel vehicle; Drug: Calcipotriene

Interventions

0.03% E6201 DRUG

Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 1

0.1% E6201 DRUG

Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 1

0.2% E6201 DRUG

Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 1

0.005% E6201 DRUG

Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 2

0.01% E6201 DRUG

Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 2

0.05% E6201 DRUG

Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 2

Placebo - 0.03% gel vehicle OTHER

Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 1

Placebo - 0.1% gel vehicle OTHER

Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 1

Placebo - 0.2% gel vehicle OTHER

Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 1

Placebo - 0.05% gel vehicle OTHER

Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 2

Placebo - 0.01% gel vehicle OTHER

Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

Cohort 2

Calcipotriene DRUG

Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque.

Also known as: Daivonex

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic stable plaque psoriasis with one or two stable psoriatic plaques(s) suitable in size and location for five separate treatment fields to be assessed within it.
• Males and females aged between 18 and 75 years of age
• The general physical examination should be normal (excluding the skin examination for psoriasis) unless the Investigator considers an abnormality not to be clinically significant with regard to the study
• Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug(s) (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception throughout the study period and for 30 days after the last dose of study drug.
• Provide written informed consent
• Willing and able to comply with all aspects of the protocol

You may not qualify if:

• Any clinically significant skin diseases other then chronic stable plaque psoriasis
• Other types of psoriasis than chronic stable plaque variant eg, guttate, pustular, erythodermic, etc
• An unstable course of the disease defined as flare(s) in the previous month
• Subjects who used any concommitant topical treatment for the psoriatic plaque(s) to be studied (other than emollients or salicylic acid) within 8 weeks before the Baseline visit eg corticosteroids or topical immunomodulators, anthralin (dithranil), vitamin D derivatives, ultraviolet-light therapy including sunbathing , or retinoids.
• Subjects who used any of the following systemic treatments within 12 weeks before the Baseline visit eg: corticosteroids or adrenocorticotrophic hormone analogs, retinoids such as acitretin or isotretinoin, cyclosporin, interferon, methotrexate, other immuno-suppressive/immunomodulating drugs, psoralen and ultraviolet A therapy, or biologics
• Subjects planning on significant exposure to sun (sun-bathing)
• Treatment with systemic or locally acting medications which might counter or influence the study aim (eg monoamine oxidase inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, eg Beta-blockers, antimalarial drugs, and lithium within two weeks before the Baseline visit
• Subject is a dependent person, ie, a relative/family member of the Investigator and/or is a member of the Investigator's staff
• Clinical study participation with any investigational drug less than 30 days prior to study entry or planning to receive an investigational drug during the study period

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (1)

Bioskin GmbH

Berlin, Germany

Location

MeSH Terms

Interventions

14-(ethylamino)-8,9,16-trihydroxy-3,4-dimethyl-3,4,9,19-tetrahydro-1H-2-benzoxacyclotetradecine-1,7(8H)-dione; Gels; calcipotriene

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Medical Research Inc.

esi_medinfo@eisai.com

1-888-274-2378

Study Officials

• Joseph Mercer

  Eisai Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: December 31, 2010
• Study Start: March 15, 2010
• Primary Completion: December 11, 2010
• Study Completion: December 11, 2010
• Last Updated: June 11, 2021
• Results First Posted: June 11, 2021

Record last verified: 2021-05

Locations

DE (1)