Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo

Completed · Phase 2

Conditions studied: Vitiligo

In brief

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

Key facts

Study ID

NCT04103060

Run by

Dermavant Sciences GmbH

People needed

33

Starts

2019-09-27

Expected to finish

2020-11-03

Last updated by the study team

2020-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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;

Where it is running

• Dermavant Investigational Site — Irvine, California, United States
• Dermavant Investigational Site — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.