A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Organon and Co
- Enrollment
- 187
- Locations
- 85
- Primary Endpoint
- Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Months to 23 Months (Child)
- 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
Arms & Interventions
Tapinarof cream
Tapinarof cream, 1%, applied topically once daily
Intervention: Tapinarof cream, 1% (Drug)
Vehicle cream
Vehicle cream is applied topically once daily for up to 8-weeks.
Intervention: Vehicle Cream (Drug)
Outcomes
Primary Outcomes
Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.
Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period
Time Frame: Baseline to the end of the Open-Label Period, up to 56 weeks.
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 scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.
Secondary Outcomes
- Number of participants with one or more Treatment Emergent Adverse Events (TEAEs)(Baseline to last planned visit in the Double-Blind Period, up to 8 weeks)
- Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)(Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .)
- Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall)(Baseline to last planned visit in the Double-Blind Period, up to 8 weeks)
- Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas)(Baseline to last planned visit in the Double-Blind Period, up to 8 weeks)
- Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8.(Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.)
- Mean change in percentage of total body surface area (%BSA) affected from Baseline to Week 8(Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.)
- Number of participants with one or more Treatment Emergent Adverse Events (TEAEs)(Baseline to the end of the Open-Label Period, up to 56 weeks)
- Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8(Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.)
- Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)(Baseline to the end of the Open-Label Period, up to 56 weeks.)
- Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall)(Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.)
- Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas)(Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.)