A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).

Detailed Description
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AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.

Official Title
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A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: OPA-15406
* Drug: Vehicle ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants 10-70 years of age Diagnosis of AD History of AD for at least 3 years AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s) Exclusion Criteria: Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit. Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3% OPA-15406<br>OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. | Drug: OPA-15406<br>* OPA-15406 topical ointment<br>|
| Experimental: 1% OPA-15406<br>OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. | Drug: OPA-15406<br>* OPA-15406 topical ointment<br>|
| Placebo Comparator: Vehicle Ointment<br>OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. | Drug: Vehicle ointment<br>* OPA-15406 1%-matching placebo topical ointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)] | The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis] | The IGA evaluation was performed by a certified rater. The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. A negative change from Baseline indicates improvement in overall IGA score. | Baseline, Week 4 | 
| Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis] | The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. Missing overall IGA scores at Week 4 were imputed using LOCF method. A negative change from Baseline indicates improvement in overall IGA score. | Baseline, Week 4 | 
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An serious adverse event (SAE) was defined as any event which resulted in death, was life-threatening, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly/birth defect, or was another medically significant event. | From signing of informed consent through Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Eczema