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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103060
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Dermavant Sciences GmbH

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

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




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



Information from the National Library of Medicine

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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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103060


Contacts
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Contact: Dermavant Sciences 480-666-0844 dermavantclinicaltrials@dermavant.com

Locations
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United States, California
Dermavant Investigational Site Recruiting
Irvine, California, United States, 92617
Contact: Narinder Singh    949-824-6483    narins1@hs.uci.edu   
Contact: Pezhman Mobasher       pmobashe@hs.uci.edu   
United States, Massachusetts
Dermavant Investigational Site Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Dermatology Research Office    774-455-4758      
Sponsors and Collaborators
Dermavant Sciences GmbH
Investigators
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Study Director: Michael McLaughlin Dermavant Sciences GmbH
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Responsible Party: Dermavant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04103060    
Other Study ID Numbers: DMVT-502-2101
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases