Clinical trial NCT04103060: Safety and Tolerability Study 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitiligo
Lead sponsor: Dermavant Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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;

Primary outcomes:
measure: Vital signs
timeFrame: Baseline through Week 7
measure: Laboratory Values
timeFrame: Baseline through Week 7
measure: Adverse Events
timeFrame: Baseline through Week 7
measure: Local Tolerability Scale Score
timeFrame: Baseline, Week 2, Week 4, Week 6, and Week 7
Secondary outcomes:
measure: Concentration of cerdulatinib
timeFrame: Days 1, 15, 29 and 43
measure: Blister fluid biomarker concentration
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Dermavant Investigational Site
state: California
city: Worcester
country: United States
facility: Dermavant Investigational Site
state: Massachusetts
Study officials:
affiliation: Dermavant Sciences GmbH
name: Michael McLaughlin
role: STUDY_DIRECTOR
References: