Inside Vitiligo’s Newest Clinical Trial Testing JAK Inhibitors
This past November, the vitiligo medical community announced a new multi-center clinical trial that will test a topical cream on patients with vitiligo.
According to Dr. John Harris, director of the University of Massachusetts Vitiligo Clinic and Research Center, there have only been a couple clinical trials in the past 70 years – so this is big news. Even better, Dr. Harris reported that more clinical trials are on their way, giving the vitiligo community hope for better treatments in the future.
Why are clinical trials on the rise?
So why are we seeing more clinical trials all of a sudden? The increase in trials is largely due to the fact that the key pathways responsible for causing vitiligo in the skin have been identified, making it easier for researchers to determine which treatments are most likely to work for patients. In addition, psoriasis, another inflammatory skin disease that has previously received much more attention from pharmaceutical companies, is so easy to treat that there is not much room for new therapies. So companies are looking for other diseases to target, and vitiligo is one of those. This “perfect storm” of events has led to new clinical trials for vitiligo. Dr. Harris also said he’s been pushing vitiligo too – working to convince companies that vitiligo is a good place to investment their efforts for more treatments.
What is being tested in this new clinical trial?
Conducted by Incyte, a biopharmaceutical company, the study will test their drug (INCB018424 Phosphate) ruxolitinib as a topical cream for vitiligo. The drug, which is a JAK inhibitor, works by inhibiting Janus Kinases (JAKs), which are important for signals that tell the immune cells where to go and what to do. Remember that with vitiligo, the immune system is sending signals that tell the immune cells to kill melanocytes (skin cells). By stopping those signals, the drug can prevent the loss of pigment. Previously, the same drug has been tested in a single patient with vitiligo as an oral treatment with rapid beneficial effects. The drug was then formulated into a tropical cream and was recently found to be effective for a small number of vitiligo studies in a preliminary study.
How does the clinical trial work?
Enrolling 150 patients nationwide that meet select criteria, the clinical trial will last over two years – 120 weeks to be exact – and requires 20 visits to a clinic for the duration of the study. The study is a randomized, double-blind, dose-ranging clinical trial, which means patients will be randomly placed in groups and some patients will receive the cream at different doses while others receive a control cream (placebo group) that does not contain any medication. After 24 weeks of treatment, participants who received placebo will be given some concentration of the drug to try as well. After one year in the trial, all participants who continue to be eligible will receive the highest concentration of the drug to use for another year.
What is the goal of the trial?
The main goal of the study is to examine whether patients achieve at least 50% improvement in vitiligo on the face after six months of applying the study cream at different concentrations. In addition to the face, the cream will be applied to lesions on the body and improvement of the whole body will be measured as well. The total area of the body that can be treated with the cream is 20%, so if more than 20% of the patient’s body is affected with vitiligo, not all of the skin will be treated. The study will also determine the safety of the medication.
How does this cream differ from existing treatments?
Existing treatments are quite broad, suppressing immune cells in the skin without much specificity to what they are shutting off. So while they shut off parts responsible for vitiligo, they also shut off parts of the immune response that don’t need to be. The new treatment is more “targeted,” meaning it is blocking a smaller part of the immune response, which should be more effective with fewer side effects. However, this won’t be officially determined until the study results are in.
How can you participate in a vitiligo clinical trial?
With more clinical trials coming, doctors and scientists are looking to patients with vitiligo to help test these new and upcoming drugs. Patients can find out about new clinical trials and how to apply at https://clinicaltrials.gov/ or sign up to receive news and information directly from Dr. Harris at https://www.umassmed.edu/vitiligo/about/subscribe/.
Erika Page is a writer and blogger with universal vitiligo. Her first spots appeared on her spine when she was seven years old and today vitiligo covers her entire body. Based just south of Washington, D.C., Erika founded Living Dappled to create a community of inspiration and hope for girls and women living with vitiligo.