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NEW CLINICAL TRIAL IS AVAILABLE FOR VITILIGO

Dear Susan,

I am excited to share with you some important news about a new nationwide clinical trial for vitiligo. It calls “A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects with Vitiligo”. The study will be conducted by Incyte, and will test their drug (INCB018424 Phosphate) ruxolitinib as a topical cream for vitiligo. This is the same drug that we tested in a single patient with vitiligo as an oral treatment, which had a rapid beneficial effect – you can read more about that patient here. For more information on using this family of drugs, called JAK inhibitors, for vitiligo here.
 
This same drug formulated into a topical cream was recently found to be effective for a small number of vitiligo patients in a preliminary study. Because the treatment was most effective on the face of patients with vitiligo, the study will require participants to have some of their vitiligo on their face. In order to qualify for this study, you must meet a certain set of requirements, known as inclusion criteria.
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Some of the key inclusion criteria are as follows:

• You are 18 to 75 years of age, male or female
• You have been diagnosed with vitiligo by a healthcare professional
• You have white areas on your face, which, when added up, cover an area roughly the size of your palm or larger
• You have lesions on your body, which, when added up, cover an area roughly the size of three of your handprints (the entire hand, palm plus fingers)
• You agree to discontinue all treatments you use to treat vitiligo while you are participating in the clinical trial, including creams, phototherapy, and any oral medicines

This trial is now seeking to enroll 150 eligible patients nationwide. It will last a little over 2 years (120 weeks) and requires 20 visits to the clinic for the duration of the study. It is a randomized, double-blind, dose-ranging clinical trial, which means patients will randomly be placed in groups with some patients receiving the INCB018424 cream at different doses while others receive a control cream (placebo group) that does not contain any medication. Various doses of the cream will be studied. The study drug to placebo ratio is 4:1 – in other words, you will have an 80% chance of being on the actual drug and a 20% chance of being on placebo during the first (24 weeks) 6 months of the study. After 24 weeks of treatment, participants who received placebo will be given some concentration of the drug to try as well. After 1 year in the trial, all participants who continue to be eligible will receive the highest concentration of the drug to use for another year.

This clinical trial will help us determine if the study cream can cause improvement in vitiligo. The main goal of this study is to examine whether patients achieve at least 50% improvement in vitiligo on the face after 6 months of applying the study cream at different concentrations. We will also be determining the safety of the medication. In addition to the face, the cream will be applied to lesions on the body and we will be measuring improvement of the whole body as well. The total area of the body that can be treated with the cream is 20%, so if more than 20% of your body is affected with vitiligo you will not be able to treat all of the skin.
 

If you are interested in reading more of the details, or want to find a clinical trial location near you, you can find them listed here and on the Incyte website.
  
We are very excited to start clinical trials in vitiligo patients, and believe that this is just the tip of the iceberg. So, if you don’t qualify for this trial for some reason, there will be more to come! 

Sincerely,

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DR. JOHN E. HARRIS, MD, PhD
Associate Professor of Dermatology,
Director of the Vitiligo Clinic and Research Center
at University of Massachusetts Medical School