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Study Complete
Sponsor ID
20080470

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

Sponsor ID
20080470
Clinicaltrials.gov ID
NCT01235442
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
Single (Outcomes Assessor)
Enrollment
592
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the efficacy of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the proportion of subjects achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75)

Timeframe: 12 weeks

Secondary Outcome Measures

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: The proportion of subjects with a static physicians global assessment(sPGA) of clear or almost clear

Timeframe: 12 weeks

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: The proportion of subjects achieving PASI 90

Timeframe: 12 weeks

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: Patient satisfaction with treatment

Timeframe: 12 weeks

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: Percent PASI improvement from baseline

Timeframe: 12 weeks

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: The proportion of subjects achieving PASI 75

Timeframe: 24 weeks

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: The proportion of subjects with sPGA of clear or almost clear

Timeframe: 24 weeks

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: Subject incidence and event rates of adverse events

Timeframe: N/A

To evaluate the efficacy and safety of adding clobetasol propionate foam to etanercept compared with etanercept monotherapy as measured by the following: Laboratory Assessments

Timeframe: N/A

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Sep 2010 - Oct 2011
    Inclusion and Exclusion 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®).