A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS

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Study Overview

You are being asked to take part in this research study because you have moderate to severe dermatomyositis (DM) and you have failed one of the previous drug therapies you were taking for DM. There are additional criteria that you must meet to ensure you are a good candidate for this study as well as to ensure your safety. Dermatomyositis is an autoimmune disease that causes the immune system to make antibodies, or proteins, that normally fight infection but instead attack a part or parts of the body. The disease affects the skin and may affect other organs of the body such as the heart, the lungs and the muscles, causing inflammation, pain and tissue injury. In addition to causing physical symptoms, DM also affects quality of life.

Study Description

The purpose of this research study is to compare the effects of the study drug, PF-06823859, with placebo to find out which is better for treating people who have moderate to severe dermatomyositis (DM). The placebo will look like the study drug PF-06823859 but it will not contain active ingredients. The study drug is designed to fight inflammation by working directly on the immune system, by neutralizing some of the naturally occurring beta interferon. It is thought that people with dermatomyositis (DM) have higher levels of beta interferon moving around in their body. This may play a role in the signs and symptoms of DM disease. In this research study, Pfizer is enrolling a group of participants meeting eligibility criteria who have skin disease and another group of participants meeting eligibility who have moderate muscle disease. The study doctor at the site will decide which group you should be placed in. When you meet all eligibility criteria, you will be assigned a drug sequence. You will be assigned by chance (like the flip of a coin or drawing straws) to receive either study drug PF-06823859 or placebo.

  • Study Identifier: 828619

Recruitment Status

Open

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