Psoriasis
Conditions
Keywords
Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe
Brief summary
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.
Interventions
DRUGEtanercept
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period
Exclusion criteria
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12 | — |
| Psoriasis pain (VAS) at week 12 | — |
| Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12 | — |
| PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy | — |
| Dermatology Live Quality Index (DLQI) response at week 12 | — |
| Adverse events, infections injection site reactions during long-term therapy | — |
| Serious adverse events and infections during long-term therapy | — |
| Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy | — |
| Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy | — |
Outcome results
None listed