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

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT05142774

Run by

Organon and Co

People needed

728

Starts

2021-10-28

Expected to finish

2024-03-07

Last updated by the study team

2025-08-13

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Dermavant Investigative Site — Phoenix, Arizona, United States
• Dermavant Investigative Site — Scottsdale, Arizona, United States
• Dermavant Investigative Site — Scottsdale, Arizona, United States
• Dermavant Investigative Site — Bryant, Arkansas, United States
• Dermavant Investigative Site — Fort Smith, Arkansas, United States
• Dermavant Investigative Site — Cerritos, California, United States
• Dermavant Investigative Site — Fountain Valley, California, United States
• Dermavant Investigative Site — Fremont, California, United States
• Dermavant Investigative Site — Huntington Beach, California, United States
• Dermavant Investigative Site — Inglewood, California, United States
• Dermavant Investigative Site — Lancaster, California, United States
• Dermavant Investigative Site — Long Beach, California, United States
• Dermavant Investigative Site — Los Angeles, California, United States
• Dermavant Investigative Site — Los Angeles, California, United States
• Dermavant Investigative Site — Los Angeles, California, United States
• Dermavant Investigative Site — Mission Viejo, California, United States
• Dermavant Investigative Site — Sacramento, California, United States
• Dermavant Investigative Site — San Diego, California, United States
• Dermavant Investigative Site — San Francisco, California, United States
• Dermavant Investigative Site — Santa Ana, California, United States
• Dermavant Investigative Site — Santa Monica, California, United States
• Dermavant Investigative Site — Thousand Oaks, California, United States
• Dermavant Investigative Site — Thornton, Colorado, United States
• Dermavant Investigative Site — Washington D.C., District of Columbia, United States
• Dermavant Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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