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

NCT04103060 | Completed Phase 2 FDA Drug

• 1 other identifier: DMVT-502-2101
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Concentration of cerdulatinib

  Days 1, 15, 29 and 43

• Blister fluid biomarker concentration

  Baseline and Week 6

Study Arms (2)

Cerdulatinib 0.37% gel

EXPERIMENTAL

Cerdulatinib 0.37% gel applied topically twice daily

Drug: Cerdulatinib 0.37% gel

Vehicle gel

PLACEBO COMPARATOR

Vehicle gel applied topically twice daily

Drug: Vehicle gel

Interventions

Cerdulatinib 0.37% gel DRUG

Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks

Also known as: DMVT-502

Cerdulatinib 0.37% gel

Vehicle gel DRUG

Vehicle gel applied topically twice daily for 6 weeks

Vehicle gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Dermavant Sciences GmbH: lead

Study Sites (2)

Dermavant Investigational Site

Irvine, California, 92617, United States

Location

Dermavant Investigational Site

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

4-(cyclopropylamino)-2-((4-(4-(ethylsulfonyl)piperazin-1-yl)phenyl)amino)pyrimidine-5-carboxamide; Gels

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michael McLaughlin

  Dermavant Sciences GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 25, 2019
• Study Start: September 27, 2019
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)