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

NCT ID: NCT04103060

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2020-11-03

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

Detailed Description

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Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cerdulatinib 0.37% gel

Cerdulatinib 0.37% gel applied topically twice daily

Group Type EXPERIMENTAL

Cerdulatinib 0.37% gel

Intervention Type DRUG

Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks

Vehicle gel

Vehicle gel applied topically twice daily

Group Type PLACEBO_COMPARATOR

Vehicle gel

Intervention Type DRUG

Vehicle gel applied topically twice daily for 6 weeks

Interventions

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Cerdulatinib 0.37% gel

Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks

Intervention Type DRUG

Vehicle gel

Vehicle gel applied topically twice daily for 6 weeks

Intervention Type DRUG

Other Intervention Names

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DMVT-502

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dermavant Sciences GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael McLaughlin

Role: STUDY_DIRECTOR

Dermavant Sciences GmbH

Locations

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Dermavant Investigational Site

Irvine, California, United States

Site Status

Dermavant Investigational Site

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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DMVT-502-2101

Identifier Type: -

Identifier Source: org_study_id