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Trial record 2 of 4 for:    tapinarof

Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

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ClinicalTrials.gov Identifier: NCT04053387
Recruitment Status : Enrolling by invitation
First Posted : August 12, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
IQVIA Biotech
Information provided by (Responsible Party):
Dermavant Sciences GmbH

Brief Summary:
This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: DMVT-505 (tapinarof cream, 1%) Phase 3

Detailed Description:
At the completion of the Week-12 visit of the pivotal study (Baseline [Day 1] in this study), all eligible subjects will be offered enrollment in the long-term extension study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 44 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects in this study completed treatment with tapinarof or vehicle in 1 of 2 parent Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). The study will consist of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% for the Treatment of Plaque Psoriasis in Adults
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Tapinarof (DMVT-505) Cream Group
Tapinarof cream, 1%, applied once daily
Drug: DMVT-505 (tapinarof cream, 1%)
Tapinarof cream, 1%, applied once daily




Primary Outcome Measures :
  1. AEs and SAEs [ Time Frame: Baseline up to 44 weeks ]
    Incidence, frequency, and nature of adverse events (AEs) and serious adverse events (SAEs)

  2. Number of subjects with clinically significant laboratory test abnormalities. [ Time Frame: Baseline up to 44 weeks ]
  3. Number of subjects with clinically significant vital sign abnormalities [ Time Frame: Baseline up to 44 weeks ]
  4. Treatment Success [ Time Frame: Baseline up to 44 weeks ]
    Median time from each treatment success (Physician Global Assessment [PGA] 0 or 1) to each subsequent worsening (PGA ≥2)

  5. Proportion of subjects who have a PGA score of clear (0) after treatment [ Time Frame: Baseline up to 44 weeks ]
    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 or erythema, scaling and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.

  6. Proportion of subjects who have a PGA score of clear or almost clear (0 or 1) after treatment [ Time Frame: Baseline up to 44 weeks ]
    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 or erythema, scaling and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.

  7. Proportion of subjects who do not experience disease worsening (PGA ≥ 2) [ Time Frame: Baseline up to 44 weeks ]
    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 or erythema, scaling and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.

  8. Change over time in percent of total body surface area (%BSA) affected [ Time Frame: Baseline up to 44 weeks ]
    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.

  9. Duration [ Time Frame: Baseline up to 44 weeks ]
    Mean duration of each treatment course

  10. Percent change over time in Psoriasis Area and Severity Index (PASI) score [ Time Frame: Baseline up to 44 weeks ]
    The PASI scoring system is a widely-used standard clinical tool for assessing the severity of severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %BSA affected with psoriasis. Higher PASI scores indicate more severe disease.

  11. Change in disease impact on daily activities, as measured by the Dermatology Life Quality Index (DLQI) total and individual dimension scores [ Time Frame: Baseline up to 44 weeks ]
    The DLQI is a simple dermatology-specific 10-question validated questionnaire to assess the impact of the disease on a subject's quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.



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.


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

Inclusion Criteria:

  1. Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002);
  2. Male and female subjects
  3. 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 while on the study, and for at least 4 weeks after the last exposure to study treatment
  4. Capable of giving written informed consent

Exclusion Criteria:

  1. Used a prohibited concomitant product or procedure to treat psoriasis during parent study
  2. Had a serious adverse event (SAE) that was potentially related to treatment or experienced an adverse event (AE) that led to permanent discontinuation of treatment in the parent study
  3. History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's completion of the study
  4. Known hypersensitivity to 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): NCT04053387


  Show 48 Study Locations
Sponsors and Collaborators
Dermavant Sciences GmbH
IQVIA Biotech
Investigators
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Study Director: Victoria Butners Dermavant Sciences GmbH

Publications of Results:
Cappon GD and Hurtt ME. Developmental toxicity of the kidney. In: Kapp RW and Yyl L, editors. Reproductive Toxicology, Target Organ Series, 3rd edition. New York:Informa Healthcare, 2010:193-204.
Frazier KS and Seely JC. Urinary system. In: Sahota PS, Popp JA, Hardisty JF and Gopinath C, editors. Toxicologic Pathology: Nonclinical Safety Assessment. CRC Press, 2013:421-84
International Conference on Harmonisation, Guideline for the extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions. 1994. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E1/Step4/E1_Guideline.pdf.

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Responsible Party: Dermavant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04053387     History of Changes
Other Study ID Numbers: DMVT-505-3003
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
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
Keywords provided by Dermavant Sciences GmbH:
Tapinarof
plaque psoriasis,
adult
phase 3
topical
open-label
efficacy
safety
psoriasis
long-term
therapeutic aryl hydrocarbon receptor modulating agent
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases