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

NCT01235442 | Completed Phase 3 Results

• 1 other identifier: 20080470
• Study Type: interventional
• Target: 592
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Psoriasis; Topical; etanercept; clobetasol propionate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• sPGA (0,1) at Week 12

  Week 12

• PASI 90 at Week 12

  Week 12

• Patient Satisfaction at Week 12

  Week 12

• Percent PASI Improvement From Baseline at Week 12

  Week 12

• PASI 75 at Week 24

  Week 24

Study Arms (2)

etanercept and clobetasol

EXPERIMENTAL

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

etanercept

EXPERIMENTAL

Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks

Drug: 1=Etanercept

Interventions

1=Etanercept DRUG

50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.

etanercept

2=Clobetasol propionate foam DRUG

0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses

etanercept and clobetasol

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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®).

Sponsors & Collaborators

• Amgen: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Related Publications (1)

• 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.

  PMID: 23643256 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 5, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 7, 2018
• Results First Posted: October 31, 2013

Record last verified: 2015-08