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

Phase 3Active Not RecruitingNCT07265479

Organon and Co187 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

187

Conditions

Atopic Dermatitis

Interventions

Tapinarof cream, 1%DRUG

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.

Vehicle CreamDRUG

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 23 Months

Medical Language ↔ Plain English

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

Locations (46)

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

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.

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

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.

Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks.

Secondary Outcomes

Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8.

The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the %BSA affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. A higher EASI score represents more severe disease.

Data from ClinicalTrials.gov

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AllerVie Clinical Research

Birmingham, Alabama, United States

Dermatology Trial Associates

Bryant, Arkansas, United States

Dermatology Research Associates

Los Angeles, California, United States

Integrative Skin Science and Research

Sacramento, California, United States

Allergy and Asthma Medical Group and Research Center

San Diego, California, United States

Clinical Trials Research Institute

Thousand Oaks, California, United States

Clarity Dermatology

Castle Rock, Colorado, United States

Skin Care Research, LLC.

Boca Raton, Florida, United States

APEX Clinical Trials

Jacksonville, Florida, United States

TruDerm Research

Wellington, Florida, United States

...and 36 more locations

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

Assessment of %BSA is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% \[10 handprints\], upper extremities = 20% \[20 handprints\], trunk (including axillae and groin) = 30% \[30 handprints\], lower extremities, including buttocks, = 40% \[40 handprints\]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.

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

Severity Index (EASI) score from Baseline to Week 8 Description: The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.

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)

TEAEs are AEs that started on or after the first dose of study medication.

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)

TEAEs are AEs that started on or after the first dose of study medication.

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)

TEAEs are AEs that started on or after the first dose of study medication.

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)

TEAEs are AEs that started on or after the first dose of study medication.

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)

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

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)

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

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)

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

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)

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

Time frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.