Overview

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)

Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
0
Participant gender:
All
Summary
This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dermavant Sciences GmbH
Criteria
Inclusion Criteria:

- Male and female subjects ages 2 and above with clinical diagnosis of AD

- Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA

- A vIGA-AD score of ≥3 at screening and baseline

- An EASI score of ≥6 at screening and baseline

- Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3
months for ages 2 to 5 years old

- Female subjects of childbearing potential who are engaging in sexual activity that
could lead to pregnancy should use acceptable birth control methods

- Must not be pregnant

- Subject, subject's parent, or legal representative must be capable of giving written
informed consent/assent

Exclusion Criteria:

- 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)