Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    tapinarof
Previous Study | Return to List | Next Study

Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis

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: NCT04042103
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dermavant Sciences GmbH

Brief Summary:
This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Tapinarof cream, 1% Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Tapinarof (DMVT-505) cream, 1%
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Drug: Tapinarof cream, 1%
Tapinarof cream, 1% applied topically once daily
Other Name: DMVT-505




Primary Outcome Measures :
  1. AEs and SAEs [ Time Frame: Baseline to Week 4 ]
    Incidence, frequency, and nature of adverse events (AEs) and serious adverse events (SAEs)

  2. Area under the concentration-time curve of tapinarof in plasma (AUC) [ Time Frame: Day 1, Day 15, and Day 29 ]
    The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.

  3. Peak concentration of tapinarof in plasma (Cmax) [ Time Frame: Day 1, Day 15, and Day 29 ]
    The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.


Secondary Outcome Measures :
  1. Effects on QTcF [ Time Frame: Day -1, Day 1, Day 29 ]
    Change in QTcF at each post-treatment time point and concentration-QTc analysis if data permit

  2. Proportion of subjects who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    The PGA is a clinical tool for assessing the current state/severity of a subject's psoriasis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.

  3. Mean change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.

  4. Mean change in percent of total body surface area (%BSA) affected from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study
  • BSA involvement ≥ 20%
  • PGA score of ≥ 3 at screening
  • 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 written informed consent

Exclusion Criteria:

  • Psoriasis other than plaque variant
  • Any sign of infection of any of the psoriatic lesions
  • Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with the interpretation of the results
  • Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
  • Use of any prohibited medication within the indicated period before the first dose of study drug
  • Pregnant females or lactating females
  • The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
  • Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
  • Previous known participation in a clinical study with tapinarof

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): NCT04042103


Contacts
Layout table for location contacts
Contact: Dermavant Sciences 480 666-0844 dermavantclinicaltrials@dermavant.com

Locations
Layout table for location information
United States, California
Dermavant Investigational Site Recruiting
Encino, California, United States, 91436
Contact: Dermavant Sciences    480-666-0844    dermavantclinicaltrials@dermavant.com   
United States, Florida
Dermavant Investigational Site Recruiting
Sanford, Florida, United States, 32771
Contact: Dermavant Sciences    480-666-0844    dermavantclinicaltrials@dermavant.com   
United States, Pennsylvania
Dermavant Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Dermavant Sciences    480-666-0844    dermavantclinicaltrials@dermavant.com   
United States, Texas
Dermavant Investigational Site Recruiting
Austin, Texas, United States, 78759
Contact: Dermavant Sciences    480-666-0844    dermavantclinicaltrials@dermavant.com   
Dermavant Investigational Site Recruiting
San Antonio, Texas, United States, 78213
Contact: Dermavant Sciences    480-666-0844    dermavantclinicaltrials@dermavant.com   
United States, Washington
Dermavant Investigational Site Recruiting
Spokane, Washington, United States, 99202
Contact: Dermavant Sciences    480-666-0844    dermavantclinicaltrials@dermavant.com   
Sponsors and Collaborators
Dermavant Sciences GmbH
Investigators
Layout table for investigator information
Study Director: Michael McLaughlin Dermavant Sciences GmbH

Publications:
Layout table for additonal information
Responsible Party: Dermavant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04042103     History of Changes
Other Study ID Numbers: DMVT-505-2002
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases