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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: MM36 topical ointment, 1%

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Honduras
  • San Pedro Sula, Honduras
    • Medimetriks Investigational Site
• Panama
  • Panama City, Panama
    • Medimetriks Investigational Site
• United States
  • California
    • Fremont, California, United States, 94538
      • Medimetriks Investigational Site
    • Irvine, California, United States, 92697
      • Medimetriks Investigational Site
    • San Diego, California, United States, 92123
      • Medimetriks Investigational Site
  • Florida
    • Miami, Florida, United States, 33125
      • Medimetriks Investigational Site
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medimetriks Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Medimetriks Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Medimetriks Investigational Site
    • Houston, Texas, United States, 77030
      • Medimetriks Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Medimetriks Investigational Site
  • Washington
    • Spokane, Washington, United States, 99202
      • Medimetriks Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MM36 1% ointment; MM36 topical ointment, 1%, applied twice daily for 28 days	Drug: MM36 topical ointment, 1%; Twice daily application for 28 consecutive days; 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

Collaborators and Investigators

• Sponsor: Medimetriks Pharmaceuticals, Inc
• Investigators: Study Director: Noah Rosenberg, MD, Medimetriks Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): June 8, 2017
• Study Completion (Actual): June 8, 2017

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: MEDI-MM36-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED