Status:
COMPLETED
Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo
Lead Sponsor:
Dermavant Sciences GmbH
Conditions:
Vitiligo
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04103060
Start Date
September 27 2019
End Date
November 3 2020
Last Update
November 24 2020
Active Locations (2)
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1
Dermavant Investigational Site
Irvine, California, United States, 92617
2
Dermavant Investigational Site
Worcester, Massachusetts, United States, 01605