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

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

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

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Cerdulatinib 0.37% gel; Drug: Vehicle gel

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • Dermavant Investigational Site
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Dermavant Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dermavant Sciences GmbH
• Investigators: Study Director: Michael McLaughlin, Dermavant Sciences GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): November 3, 2020
• Study Completion (Actual): November 3, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: DMVT-502-2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No