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

• ClinicalTrials.gov Identifier: NCT01235442
• Recruitment Status: Completed
• First Posted: November 5, 2010
• Results First Posted: October 31, 2013
• Last Update Posted: August 7, 2018
• Sponsor: Amgen
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Amgen

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: 1=Etanercept; Drug: 2=Clobetasol propionate foam	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 592 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
• Study Start Date: September 2010
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. PASI 75 at Week 12 [ Time Frame: 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.

Secondary Outcome Measures :

1. sPGA (0,1) at Week 12 [ Time Frame: 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.
2. PASI 90 at Week 12 [ Time Frame: 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.
3. Patient Satisfaction at Week 12 [ Time Frame: 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."
4. Percent PASI Improvement From Baseline at Week 12 [ Time Frame: 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.
5. PASI 75 at Week 24 [ Time Frame: 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.
6. sPGA (0,1) at Week 24 [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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®).

Contacts and Locations

Sponsors and Collaborators

Amgen

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

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.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01235442
• Other Study ID Numbers: 20080470
• First Posted: November 5, 2010
• Results First Posted: October 31, 2013
• Last Update Posted: August 7, 2018
• Last Verified: August 2015

Keywords provided by Amgen:

Psoriasis; Topical; etanercept; clobetasol propionate

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Etanercept; Clobetasol; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists