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CompletedNCT04103060Updated Nov 24, 2020

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

A Phase 2 interventional study of Cerdulatinib 0.37% gel and Vehicle gel in Vitiligo, sponsored by Dermavant Sciences GmbH. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Dermavant Sciences GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Vitiligo

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Cerdulatinib 0.37% gel

    Cerdulatinib 0.37% gel applied topically twice daily

    Drug: Cerdulatinib 0.37% gel

  • Placebo comparator
    Vehicle gel

    Vehicle gel applied topically twice daily

    Drug: Vehicle gel

Interventions

  • DrugCerdulatinib 0.37% gel

    Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks

    Also known as: DMVT-502

  • DrugVehicle gel

    Vehicle gel applied topically twice daily for 6 weeks

05

What researchers measure

Primary outcomes

  1. Vital signs

    Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)

    Time frame: Baseline through Week 7

  2. Laboratory Values

    Clinically significant abnormal lab values

    Time frame: Baseline through Week 7

  3. Adverse Events

    Frequency, severity, and duration of adverse events

    Time frame: Baseline through Week 7

  4. Local Tolerability Scale Score

    Assessment of local site investigational product administration

    Time frame: Baseline, Week 2, Week 4, Week 6, and Week 7

Secondary outcomes

  1. Concentration of cerdulatinib

    Plasma concentration

    Time frame: Days 1, 15, 29 and 43

  2. Blister fluid biomarker concentration

    From active treated lesions and untreated nonlesional skin

    Time frame: Baseline and Week 6

06

Study locations

2 sites
  • Dermavant Investigational Site
    Irvine, California 92617, United States
  • Dermavant Investigational Site
    Worcester, Massachusetts 01605, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04103060
Lead sponsor
Dermavant Sciences GmbH
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Sep 27, 2019
Primary completion
Nov 3, 2020
Completion
Nov 3, 2020
Last update
Nov 24, 2020

Study contacts

Michael McLaughlin
study director · Dermavant Sciences GmbH

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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