US drug maker AbbVie has started a Phase III clinical trial designed to assess the use of Humira (adalimumab) as a treatment for fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis.
Psoriasis is a non-contagious, chronic immune disease that speeds the growth cycle of skin cells and results in thick, scaly areas of skin.
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It can also affect the fingernails causing pitting, discoloration, loosening and irregular contour of the fingernail.
The company said that currently there are no approved treatments for fingernail psoriasis.
The prevalence of fingernail psoriasis in people with moderate to severe chronic plaque psoriasis is unknown, but it is expected that about 50% of the 125 million people across the world with psoriasis have nail involvement.
Oregon Health Science University clinical adjunct professor of dermatology Phoebe Rich said: "Since treatment options are limited, we welcome research that evaluates new options for patients suffering from this disease and are excited to start evaluating adalimumab in this patient population."
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By GlobalDataAround 200 patients with moderate to severe chronic plaque psoriasis with fingernail psoriasis are expected to be enrolled in the multinational, double-blind, placebo-controlled trial.
The 26-week trial will be carried out at about 32 sites worldwide, including the UK, Ireland, Germany, Greece, Belgium, France, Australia, Canada, Mexico, and the US.
Primary endpoints for the trial will be evaluated after 26 weeks and are based on advice received from regulatory agencies.
AbbVie vice-president of immunology clinical development John Medich said for more than a decade, Humira has served as an important treatment option for patients with chronic inflammatory diseases.
"This new clinical trial marks our ongoing commitment to patients living with psoriasis and we look forward to further evaluating the medicine’s potential on clinical outcomes in this patient population," Medich said.
The Phase III trial will evaluate the percent of patients who achieve a Physicians Global Assessment of Fingernail Psoriasis (PGA-F) of either ‘clear’ or ‘minimal’ and assess the percent of patients who achieve a 75% reduction in fingernail psoriasis, as defined by the modified Nail Psoriasis Severity Index (mNAPSI).
Humira is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections.
Image: Psoriasis affecting a fingernail. Photo: courtesy of Fluzwup.
