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

  • STATUS
    Recruiting
  • End date
    Sep 23, 2024
  • participants needed
    961
  • sponsor
    Dermavant Sciences, Inc.
Updated on 23 March 2022
topical agents

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.

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).

Details
Condition Atopic Dermatitis
Treatment Tapinarof cream, 1%
Clinical Study IdentifierNCT05142774
SponsorDermavant Sciences, Inc.
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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)
Used a prohibited concomitant product or procedure to treat AD during the pivotal study
Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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