Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.

Official Title
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A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: 0.3% OPA-15406 ointment
* Drug: 1% OPA-15406 ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: At least 2 years (at time of obtaining informed consent) Diagnosis of AD based on the Japanese Dermatological Association's criteria Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the screening and baseline examinations Exclusion Criteria: - Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Ages Eligible for Study
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Minimum Age: 2 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3% OPA-15406 ointment<br>Twice daily | Drug: 0.3% OPA-15406 ointment<br>* Twice daily<br>|
| Experimental: 1% OPA-15406 ointment<br>Twice daily | Drug: 1% OPA-15406 ointment<br>* Twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs). | Treatment period (52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate of Investigator's Global Assessment (IGA) | The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 52. Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline. | Week 52 | 
| Responder Rate of Eczema Area and Severity Index 75 (EASI 75) | The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD. The investigator or sub investigator scored the severity (0-3 points) and affected body surface area (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). EASI 75 is defined as the rate of subjects whose EASI score has improved at least 75% from baseline. | Week 52 |