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

Study Overview
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Brief Summary
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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
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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

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Cerdulatinib 0.37% gel
* Drug: Vehicle gel


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerdulatinib 0.37% gel<br>Cerdulatinib 0.37% gel applied topically twice daily | Drug: Cerdulatinib 0.37% gel<br>* Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks<br>* Other names: DMVT-502;|
| Placebo Comparator: Vehicle gel<br>Vehicle gel applied topically twice daily | Drug: Vehicle gel<br>* Vehicle gel applied topically twice daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs | Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate) | Baseline through Week 7 | 
| Laboratory Values | Clinically significant abnormal lab values | Baseline through Week 7 | 
| Adverse Events | Frequency, severity, and duration of adverse events | Baseline through Week 7 | 
| Local Tolerability Scale Score | Assessment of local site investigational product administration | Baseline, Week 2, Week 4, Week 6, and Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of cerdulatinib | Plasma concentration | Days 1, 15, 29 and 43 | 
| Blister fluid biomarker concentration | From active treated lesions and untreated nonlesional skin | Baseline and Week 6 |