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

Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103060
• Other study ID #: DMVT-502-2101
• Status: Completed
• Phase: Phase 2
• Start date: September 27, 2019
• Est. completion date: November 3, 2020

Study information

• Verified date: November 2020
• Source: Dermavant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Cerdulatinib 0.37% gel
Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks
• Vehicle gel
Vehicle gel applied topically twice daily for 6 weeks

Locations

Country	Name	City	State
United States	Dermavant Investigational Site	Irvine	California
United States	Dermavant Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dermavant Sciences GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs	Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)	Baseline through Week 7
Primary	Laboratory Values	Clinically significant abnormal lab values	Baseline through Week 7
Primary	Adverse Events	Frequency, severity, and duration of adverse events	Baseline through Week 7
Primary	Local Tolerability Scale Score	Assessment of local site investigational product administration	Baseline, Week 2, Week 4, Week 6, and Week 7
Secondary	Concentration of cerdulatinib	Plasma concentration	Days 1, 15, 29 and 43
Secondary	Blister fluid biomarker concentration	From active treated lesions and untreated nonlesional skin	Baseline and Week 6