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Psoriasis Foundation statement regarding halt of psoriasis drug trial

April 7, 2005

On April 6, 2005, Serono, S.A. ended their late-stage clinical trials for onercept, a TNF-inhibitor biologic. The onercept trials were halted because the efficacy response was less than that observed in earlier trials; that is, the drug did not work well enough to continue the trials. These trials were designed with the U.S. Food and Drug Administration to evaluate efficacy and safety. Onercept was a drug in development and has not been approved for any indication. Two trial participants were diagnosed with sepsis, which is a toxic condition resulting from the spread of bacteria or bacterial products from a focus of infection; one of the patients died from sepsis.

The National Psoriasis Foundation is saddened by the death of a psoriasis patient during clinical trials for treatment. This event underscores the importance of talking with your doctor about treatment options and the careful weighing of risks, convenience and efficacy of treatment. If you have a question about your treatment, contact your doctor directly.

Headquartered in Portland, Ore., the National Psoriasis Foundation is a patient-driven nonprofit organization dedicated to improving the quality of life of more than 5 million Americans diagnosed with psoriasis and/or psoriatic arthritis and their families. For more information, please call the Psoriasis Foundation at 800.723.9166 or visit www.psoriasis.org.


Posted on April 07, 2005
Updated on April 12, 2005
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