Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: 2=Clobetasol propionate foam; Drug: 1=Etanercept

• Study Type: Interventional
• Enrollment (Actual): 592
• Phase: Phase 3

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:

• Subject has had stable moderate to severe plaque psoriasis for at least 6 months
• Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.
• Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria:

• Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
• Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.
• Subject diagnosed with medication-induced or medication exacerbated psoriasis
• Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection
• Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.
• Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.
• Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies
• Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose
• Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept
• Subject has ever used efalizumab (Raptiva®).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: etanercept and clobetasol; Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)	Drug: 2=Clobetasol propionate foam; 0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses
Experimental: etanercept; Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks	Drug: 1=Etanercept; 50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI 75 at Week 12	The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sPGA (0,1) at Week 12	The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.	Week 12
PASI 90 at Week 12	The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.	Week 12
Patient Satisfaction at Week 12	Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied."	Week 12
Percent PASI Improvement From Baseline at Week 12	The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.	Week 12
PASI 75 at Week 24	The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.	Week 24
sPGA (0,1) at Week 24	The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.	Week 24

Collaborators and Investigators

• Sponsor: Amgen
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• Lebwohl MG, Kircik L, Callis Duffin K, Pariser D, Hooper M, Wenkert D, Thompson EH, Yang J, Kricorian G, Koo J. A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2013 Sep;69(3):385-92. doi: 10.1016/j.jaad.2013.03.031. Epub 2013 May 1.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (Estimate): November 5, 2010

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Psoriasis; Topical; etanercept; clobetasol propionate
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Etanercept; Clobetasol
• Other Study ID Numbers: 20080470