Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

This is 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

Official Title

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

Keywords

Vitiligo Cerdulatinib 0.37% gel Vehicle gel

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male and female subjects age 18 and older with a confirmed clinical diagnosis of vitiligo for at least 3 months, including ≥0.5% to ≤30% BSA involvement.
  • Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
  • Capable of giving informed consent

You CAN'T join if...

  • Diagnosis of segmental vitiligo
  • Subjects with concurrent conditions or history of other diseases (e.g., current or chronic history of liver disease) that could affect the safety of the subject or the implementation of this study
  • Use of any prohibited medication within the indicated period before the first dose of study drug
  • Pregnant or lactating females
  • Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 8 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's vitiligo
  • The subject has received an investigational product within the following time period prior to the first dosing day: 4 weeks or 5 half-lives (whichever is longer).
  • Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory test value abnormality that will affect the health of the subject or interfere with interpretation of the results
  • History of sensitivity to the study drug, or components thereof or a history of drug or other allergy that contraindicates the subject's participation in the study;

Locations

  • Dermavant Investigational Site accepting new patients
    Irvine California 92617 United States
  • Dermavant Investigational Site accepting new patients
    Worcester Massachusetts 01605 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dermavant Sciences GmbH
ID
NCT04103060
Phase
Phase 2
Study Type
Interventional
Last Updated