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agents · 1 trial · 1 indication
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value \* 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.
| Arm | Type | Description |
|---|---|---|
| Etanercept 50 mg BIW | ACTIVE_COMPARATOR | Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks. |
| Etanercept 50 mg QW + Topical | EXPERIMENTAL | Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents. |
| Name | Type | Description |
|---|---|---|
| etanercept | BIOLOGICAL | Administered by subcutaneous injection |
| Topical agents | DRUG | Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following: * hydrocortisone 2.5% * betamethasone valerate 0.1% * betamethasone dipropionate 0.05% * clobetasol 0.05% * calcitriol * calcipotriol plus betamethsone dipropionate 0.05% |
Inclusion Criteria: * Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator). * Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 1...
agents is an investigational small molecule being studied for the treatment of psoriasis. It is currently in Phase 3 clinical development. The drug is being evaluated for its efficacy and safety in patients with moderate to severe plaque psoriasis.
agents is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in patients with psoriasis.
agents is in Phase 3 clinical development. A Phase 3 trial has been completed, which evaluated the drug's efficacy and safety in patients with moderate to severe plaque psoriasis. The drug is still investigational and has not been approved by regulatory authorities.
agents has one completed Phase 3 clinical trial registered as NCT01313221. This trial evaluated the efficacy and safety of agents 50 mg once weekly plus as-needed topical agent in patients with moderate to severe plaque psoriasis. The study enrolled 310 participants in Canada.
The mechanism of action for agents has not been disclosed in available information. The drug is being studied as a small molecule for the treatment of psoriasis, but its specific molecular target has not been specified.