Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetic parameters and safety of topical MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.

Detailed Description
-----------------
This is a multi-center, open-label study to assess the degree of systemic exposure and safety of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in pediatric subjects with atopic dermatitis.

Official Title
-----------------
Protocol MEDI-MM36-206: A Phase 2 Multi-center, Open-label Study to Assess Pharmacokinetic Parameters and Safety of Topical MM36 (1%) in Pediatric Subjects 2 to < 18 Years of Age With Atopic Dermatitis Under Maximal Use Conditions

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: MM36 topical ointment, 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 2 to <18 years of age Diagnosis of atopic dermatitis (AD) AD affecting ≥ 35% body surface area (BSA) if 2 to < 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas) Exclusion Criteria: Active or acute viral skin infection History of recurrent bacterial infection Malignancy Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MM36 1% ointment<br>MM36 topical ointment, 1%, applied twice daily for 28 days | Drug: MM36 topical ointment, 1%<br>* Twice daily application for 28 consecutive days<br>* Other names: OPA-15406;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of MM36 | Maximum observed plasma concentration of MM36 on Day 1 | Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1 | 
| Maximum Observed Plasma Concentration (Cmax) of MM36 | Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state) | Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15 | 
| Time of Maximum Observed Plasma Concentration (Tmax) of MM36 | Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1 | Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1 | 
| Time of Maximum Observed Plasma Concentration (Tmax) of MM36 | Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15 | Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36 | Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1 | Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36 | Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15 | Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | up to 4 weeks | 
| Treatment-Emergent Adverse Events (AEs) According to Severity | Number of Participants With Treatment-Emergent Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity. | up to 4 weeks | 
| Application Site Adverse Events (AEs) | Number of Participants With Application Site Adverse Events (AEs) | up to 4 weeks | 
| Application Site Adverse Events (AEs) According to Severity | Number of Participants With Application Site Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity. | up to 4 weeks | 
| Clinically Meaningful Laboratory Test Median Changes From Baseline | Number of Participants With Clinically Meaningful Laboratory Test Median Changes From Baseline. Clinical meaningfulness of laboratory test changes was determined at the investigator's discretion. | Day 29 | 
| Clinically Meaningful Vital Sign Median Changes From Baseline | Number of Participants With Clinically Meaningful Vital Sign Median Changes From Baseline. Clinical meaningfulness of vital sign changes was determined at the investigator's discretion. | Day 29 | 
| Clinically Meaningful ECG Median Changes From Baseline to Day 15 | Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion. | Day 15 | 
| Clinically Meaningful ECG Median Changes From Baseline to Day 29 | Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion. | Day 29 |