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Purpose

The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.

Condition

Eligibility

Eligible Ages
Between 3 Months and 23 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to <24 months of age at the Screening visit. - Clinical diagnosis of atopic dermatitis (AD), AD covering >5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4 - Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities - Legal guardian or primary caregiver is able and willing to adhere to protocol requirements

Exclusion Criteria

  • Significant neurological disorder or history of seizure - Know clinically significant cardiac rhythm or cardiac disorder - History of sudden infant death in a sibling - Clinically significant chromosome abnormality - History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation - Diseases that could cause pruritic and/or sleep disruption - Immunocompromised - Current chronic or acute infection requiring treatment - Use of prohibited medication(s) or procedure(s) - Use of prohibited medications by breastfeeding mother if breastfeeding participant

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Following a screening period of up to 30 days, eligible participants will be randomly assigned to one of two groups for up to 8 weeks. During this time-called the Double-Blind Period-2 out of 3 participants will receive the active treatment (tapinarof cream, 1%), while 1 out of 3 will receive a vehicle cream (placebo). Following completion of the Double-blind period, participants will enter the 48-week Open Label Period and will be treated as needed.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tapinarof cream 		Tapinarof cream, 1%, applied topically once daily
  • Drug: Tapinarof cream, 1%
    Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.
    Other names:
    • OG-0505
    • DMVT-505
    • GSK2894512A
    • GSK28994512
    • STI-1001
    • WBI-1001
Placebo Comparator
Vehicle cream 		Vehicle cream is applied topically once daily for up to 8-weeks.
  • Drug: Vehicle Cream
    Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Recruiting Locations

The University of Texas Health Science Center at Houston
Bellaire, Texas 77401

More Details

Status
Recruiting
Sponsor
Organon and Co

Study Contact

Clinical Lead Late-Stage Clinical Development
551-430-6000
studysites@organon.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.