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

• ClinicalTrials.gov Identifier: NCT04103060
• Recruitment Status: Completed
• First Posted: September 25, 2019
• Last Update Posted: November 24, 2020
• Sponsor: Dermavant Sciences GmbH
• Information provided by (Responsible Party): Dermavant Sciences, Inc. ( Dermavant Sciences GmbH )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Vitiligo	Drug: Cerdulatinib 0.37% gel; Drug: Vehicle gel	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 27, 2019
• Actual Primary Completion Date: November 3, 2020
• Actual Study Completion Date: November 3, 2020

Arms and Interventions

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 Name: DMVT-502
Placebo Comparator: Vehicle gel; Vehicle gel applied topically twice daily	Drug: Vehicle gel; Vehicle gel applied topically twice daily for 6 weeks

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Concentration of cerdulatinib [ Time Frame: Days 1, 15, 29 and 43 ]
   Plasma concentration
2. Blister fluid biomarker concentration [ Time Frame: Baseline and Week 6 ]
   From active treated lesions and untreated nonlesional skin

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

United States, California

Dermavant Investigational Site

Irvine, California, United States, 92617

United States, Massachusetts

Dermavant Investigational Site

Worcester, Massachusetts, United States, 01605

Sponsors and Collaborators

Dermavant Sciences GmbH

Investigators

• Study Director: Michael McLaughlin; Dermavant Sciences GmbH

More Information

• Responsible Party: Dermavant Sciences GmbH
• ClinicalTrials.gov Identifier: NCT04103060
• Other Study ID Numbers: DMVT-502-2101
• First Posted: September 25, 2019
• Last Update Posted: November 24, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases