Vitiligo
Conditions
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
Interventions
DRUGCerdulatinib 0.37% gel
Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks
DRUGVehicle gel
Vehicle gel applied topically twice daily for 6 weeks
Sponsors
Dermavant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | Baseline through Week 7 | Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate) |
| Laboratory Values | Baseline through Week 7 | Clinically significant abnormal lab values |
| Adverse Events | Baseline through Week 7 | Frequency, severity, and duration of adverse events |
| Local Tolerability Scale Score | Baseline, Week 2, Week 4, Week 6, and Week 7 | Assessment of local site investigational product administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of cerdulatinib | Days 1, 15, 29 and 43 | Plasma concentration |
| Blister fluid biomarker concentration | Baseline and Week 6 | From active treated lesions and untreated nonlesional skin |
Countries
United States
Outcome results
None listed