A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

Official title

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

Overview

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.

Interventions

• 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.
• Drug Vehicle Cream
  Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Primary outcome measures

• 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.]
• 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.]

Secondary outcome measures (11)

• Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8. [Time frame: 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 [Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.]
• Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8 [Time frame: 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) [Time frame: 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) [Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks]
• Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs) [Time frame: 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) [Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks.]
• Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall) [Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks]
• Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall) [Time frame: 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) [Time frame: 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) [Time frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 36 centers

• AllerVie Clinical Research — Birmingham
• Dermatology Trial Associates — Bryant
• Dermatology Research Associates — Los Angeles
• Integrative Skin Science and Research — Sacramento
• Allergy and Asthma Medical Group and Research Center — San Diego
• Clinical Trials Research Institute — Thousand Oaks
• Clarity Dermatology — Castle Rock
• Skin Care Research, LLC. — Boca Raton
• … and 28 more centers

Canada · 10 centers

• Dermatology Research Institute — Calgary
• CARe Clinic (Central Alberta Research Clinic) — Red Deer
• Dr. Chih-Ho Hong Medical Inc. — Surrey
• Manitoba Allergy Research Inc. — Winnipeg
• Maritime Dermatology — Halifax
• Halton Pediatric Allergy — Burlington
• Triple A Lab Inc. — Hamilton
• Allergy Research Canada Inc. — Niagara Falls
• … and 2 more centers

Identifiers

NCT: NCT07265479 · OG0505-3104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗