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Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

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: NCT05142774
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Dermavant Sciences, Inc.

Study Description
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Brief Summary:
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tapinarof cream, 1% Phase 3

Detailed Description:
At the completion of the Week 8 visit of study DMVT-505-3101 or study DMVT-505-3102 or the Day 28 visit of study DMVT-505-2104, or Day 1 (Baseline) in this study, all eligible subjects will be offered enrollment in this open-label long-term extension (OL-LTE) study. Approximately 125 additional pediatric subjects ages 2 to < 18 years who are not eligible for participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be enrolled directly into this OL-LTE 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 49 weeks for rollover subjects (Baseline to Follow-up) and approximately 53 weeks for direct-enrolling subjects (Screening to Follow-up).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 961 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis
Actual Study Start Date : October 28, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tapinarof

Arms and Interventions
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Arm Intervention/treatment
Experimental: tapinarof cream
Tapinarof 1%, cream
 Drug: Tapinarof cream, 1%
Tapinarof cream, 1%, applied daily


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: Baseline to Week 49 ]
    Incidence, Frequency, and duration of treatment emergent adverse events

  2. Number of subjects with clinically significant laboratory test abnormalities [ Time Frame: Baseline up to Week 49 ]
  3. Number of subjects with clinically significant vital signs abnormalities [ Time Frame: Baseline up to Week 49 ]
  4. Mean Investigator- and Subject (or Caregiver)-assessed LTS scores by visit [ Time Frame: Baseline up to Week 48 ]
    Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.


Secondary Outcome Measures :
  1. Proportion of subjects who experience vIGA-AD of clear (0) after treatment [ Time Frame: Baseline up to Week 48 ]
    The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis 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, induration/papulation, lichenification, oozing/crusting.

  2. Proportion of subjects who experience vIGA-AD score of clear or almost clear (0 or 1) after treatment [ Time Frame: Baseline up to Week 48 ]
    The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.

  3. Proportion of subjects who do not experience disease worsening (vIGA-AD ≥ 2) [ Time Frame: Baseline up to Week 48 ]
    The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.

  4. Absolute value, change and percent change from Baseline in %BSA affected by visit [ Time Frame: Baseline to each visit ]
    The assessment of %BSA affected is an estimate of the percentage of total involved skin with AD. 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 AD will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.

  5. Absolute value, change and percent change from Baseline in Eczema Area and Severity Index (EASI) score by visit [ Time Frame: Baseline to each visit ]
    The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.

  6. Proportion of subjects with ≥ 50%, 75%, and 90% improvement in EASI score from Baseline by visit [ Time Frame: Baseline to each visit ]
    The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.

  7. Mean change in PP- NRS score [ Time Frame: Baseline to each visit ]
    The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.

  8. Proportion of subjects with a Baseline PP-NRS score ≥ 4 who achieve ≥ 4-point reduction in the PP-NRS from Baseline at each study visit [ Time Frame: Baseline to each visit ]
    The PP-NRS is a scale used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus.Higher PP-NRS ratings represent more itch reported.


Eligibility Criteria
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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:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For Roll-over Subjects Only:

  • Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study).
  • Must not be pregnant at Baseline

For Direct-Enrolling Subjects Only:

  • Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD
  • Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria.
  • AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
  • Must not be pregnant at Screening or Baseline

For All Subjects:

  • Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
  • Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria:

For Rollover Subjects Only:

  1. Subjects who were not receiving study drug at the time of the last visit in the pivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)
  2. Used a prohibited concomitant product or procedure to treat AD during the pivotal study.
  3. Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study.
  4. Pregnant females

For Direct-Enrolling Subjects:

  • Immunocompromised at screening
  • Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
  • Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
  • Screening total bilirubin > 1.5x ULN
  • Current or chronic history of liver disease
  • Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
  • Subjects who would not be considered suitable for topical therapy
  • Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
  • 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 participation in the study, interpretation of results, or ability to understand and give informed consent.
  • Pregnant or lactating females
  • History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
  • Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Contacts and Locations
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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): NCT05142774


Contacts
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Contact: Philip Brown, MD, JD 480-666-0844 dermavantclinicaltrials@dermavant.com

Locations
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Sponsors and Collaborators
Dermavant Sciences, Inc.
Investigators
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Study Director: Diana Villalobos Dermavant Sciences, Inc.
More Information
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Publications:
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
Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermato-Venereologica Supplementum. 1980;92:44-7.

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Responsible Party: Dermavant Sciences, Inc.
ClinicalTrials.gov Identifier: NCT05142774    
Other Study ID Numbers: DMVT-505-3103
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
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, Inc.:
eczema
pediatric
tapinarof
phase 3
topical
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases