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A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, and Systemic Exposure of Cerdulatinib Gel, 0.37% in Adults with Vitiligo

We are pleased to share news about a new clinical trial for vitiligo - A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, and Systemic Exposure of Cerdulatinib Gel, 0.37% in Adults with Vitiligo”. The study will be conducted by Dermavant and will test their investigational study drug DMVT-502 (cerdulatinib gel, 0.37%)  for vitiligo. You can read more information on using this family of drugs, called JAK inhibitors, for vitiligo here.

In order to qualify for this study, you must meet a certain set of requirements, known as inclusion criteria. Some of the key inclusion criteria are as follows:

  1. You are 18 or older
  2. You have been diagnosed with non-segmental vitiligo by a healthcare professional
  3. You have seen new vitiligo spots or worsening of existing spots
  4. You agree to discontinue all treatments you are currently using for the treatment of vitiligo while you are participating in the clinical trial, including creams, phototherapy, and any oral medicines
  5. You are healthy overall and have normal blood work up and labs
  6. You are comfortable with mandatory skin sample procedures done at baseline (pre-trial treatment) and at the end of the treatment period
  7. You agree to attend 7, in person, mandatory visits in Worcester, MA over a period of 11 weeks

This trial is now seeking to enroll approximately 15 eligible patients. It will last for approximately 11 weeks and requires a total of 7 visits to the clinic over the course of the study. It is a randomized, double-blind clinical trial, which means patients will randomly be placed in groups with some patients receiving the study drug while others will receive a control drug (placebo group) that does not contain any medication. The study drug to placebo ratio is 2:1 – in other words, you will have an 66.6 % chance of being on the actual drug and a 33.3 % chance of being on placebo during the study.

The goal of this study is to record the safety and tolerability of the medication, and to assess changes in biomarkers before and after topical application of the study drug compared to the placebo.  With the short treatment duration (6 weeks) we will be assessing efficacy by evaluating changes in early biomarkers that often proceed repigmentation, visually you may not see improvement of your vitiligo during this treatment duration but participating will allow us to understand the potential for this drug to treat vitiligo in later stage trials.

We will be enrolling ~ 15 subjects. If you think this clinical trial may be right for you, and if you are willing to travel to UMass site, please take the survey below  to see if you are eligible for screening. Please note eligibility for screening does not guarantee enrollment in the trial. The screening period will require more than one visit to UMass. Screening will include a visit with a clinical staff member in our clinic, a detailed history, physical exam, lab tests, EKG, and a skin sample procedure. 

TAKE THE SURVEY

The study coordinator will contact you if you pass our prescreen survey to go over screening criteria and schedule you for a screening visit.

We are excited to start this new clinical trial in vitiligo patients, and we are working on more trials that we hope to start soon. So, if you do not qualify for this trial, there will be more to come! Keep an eye out for more notices, which will come through additional newsletters.