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

• ClinicalTrials.gov Identifier: NCT02945657
• Recruitment Status: Completed
• First Posted: October 26, 2016
• Results First Posted: November 19, 2018
• Last Update Posted: November 19, 2018
• Sponsor: Medimetriks Pharmaceuticals, Inc
• Information provided by (Responsible Party): Medimetriks Pharmaceuticals, Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: MM36 topical ointment, 1%	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: October 2016
• Actual Primary Completion Date: June 8, 2017
• Actual Study Completion Date: June 8, 2017

Arms and Interventions

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 Name: OPA-15406

Outcome Measures

Primary Outcome Measures :

1. Maximum Observed Plasma Concentration (Cmax) of MM36 [ Time Frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1 ]
   Maximum observed plasma concentration of MM36 on Day 1
2. Maximum Observed Plasma Concentration (Cmax) of MM36 [ Time Frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15 ]
   Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)
3. Time of Maximum Observed Plasma Concentration (Tmax) of MM36 [ Time Frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1 ]
   Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1
4. Time of Maximum Observed Plasma Concentration (Tmax) of MM36 [ Time Frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15 ]
   Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15
5. Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36 [ Time Frame: 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 on Day 1
6. Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36 [ Time Frame: 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 on Day 15

Secondary Outcome Measures :

1. Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 4 weeks ]
   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
2. Treatment-Emergent Adverse Events (AEs) According to Severity [ Time Frame: up to 4 weeks ]
   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.
3. Application Site Adverse Events (AEs) [ Time Frame: up to 4 weeks ]
   Number of Participants With Application Site Adverse Events (AEs)
4. Application Site Adverse Events (AEs) According to Severity [ Time Frame: up to 4 weeks ]
   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.
5. Clinically Meaningful Laboratory Test Median Changes From Baseline [ Time Frame: Day 29 ]
   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.
6. Clinically Meaningful Vital Sign Median Changes From Baseline [ Time Frame: Day 29 ]
   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.
7. Clinically Meaningful ECG Median Changes From Baseline to Day 15 [ Time Frame: 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.
8. Clinically Meaningful ECG Median Changes From Baseline to Day 29 [ Time Frame: 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Medimetriks Investigational Site

Fremont, California, United States, 94538

Medimetriks Investigational Site

Irvine, California, United States, 92697

Medimetriks Investigational Site

San Diego, California, United States, 92123

United States, Florida

Medimetriks Investigational Site

Miami, Florida, United States, 33125

United States, Missouri

Medimetriks Investigational Site

Saint Joseph, Missouri, United States, 64506

United States, Oregon

Medimetriks Investigational Site

Portland, Oregon, United States, 97239

United States, Texas

Medimetriks Investigational Site

Austin, Texas, United States, 78759

Medimetriks Investigational Site

Houston, Texas, United States, 77030

United States, Virginia

Medimetriks Investigational Site

Norfolk, Virginia, United States, 23502

United States, Washington

Medimetriks Investigational Site

Spokane, Washington, United States, 99202

Honduras

Medimetriks Investigational Site

San Pedro Sula, Honduras

Panama

Medimetriks Investigational Site

Panama City, Panama

Sponsors and Collaborators

Medimetriks Pharmaceuticals, Inc

Investigators

• Study Director: Noah Rosenberg, MD; Medimetriks Pharmaceuticals, Inc

  Study Documents (Full-Text)

Documents provided by Medimetriks Pharmaceuticals, Inc:

Statistical Analysis Plan  [PDF] May 18, 2017

Study Protocol  [PDF] January 30, 2017

More Information

• Responsible Party: Medimetriks Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT02945657 History of Changes
• Other Study ID Numbers: MEDI-MM36-206
• First Posted: October 26, 2016
• Results First Posted: November 19, 2018
• Last Update Posted: November 19, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases