Humira enters new trial for Fingernail Psoriasis - Abbvie

AbbVie has announced the initiation of a pivotal Phase III clinical trial that will evaluate the use of Humira (adalimumab) as a treatment for Fingernail Psoriasis in patients with moderate to severe chronic Plaque Psoriasis, an area of unmet need. Currently there are no approved treatments for fingernail psoriasis.

The 26-week clinical trial is a multinational, double-blind, placebo-controlled study that is expected to enroll 200 patients with moderate to severe chronic plaque psoriasis with fingernail psoriasis. It will be conducted at approximately 32 sites worldwide, including the United Kingdom, Ireland, Germany, Greece, Belgium, France, Australia, Canada, Mexico, and the United States. The primary endpoints for the trial will be evaluated after 26 weeks and are based on advice received from regulatory agencies. The trial will assess the percent of patients who achieve a Physicians Global Assessment of Fingernail Psoriasis (PGA-F) of either "clear" or "minimal" and evaluate the percent of patients who achieve a 75-percent reduction in fingernail psoriasis, as defined by the modified Nail Psoriasis Severity Index (mNAPSI).