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Completed

NCT Number: NCT04103060

Safety and Tolerability Study 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermavant Investigational Site, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Cerdulatinib 0.37% gel

Drug

Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks

Other names: DMVT-502

Vehicle gel

Drug

Vehicle gel applied topically twice daily for 6 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dermavant Sciences GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2019
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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