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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MM36 topical ointment, 1%
Sponsored by
Medimetriks Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site
  • Medimetriks Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MM36 1% ointment

Arm Description

MM36 topical ointment, 1%, applied twice daily for 28 days

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of MM36
Maximum observed plasma concentration of MM36 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)
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 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
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

Secondary Outcome Measures

Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Application Site Adverse Events (AEs)
Number of Participants With Application Site Adverse Events (AEs)
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.
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.
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.
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.
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.

Full Information

First Posted
October 21, 2016
Last Updated
November 14, 2018
Sponsor
Medimetriks Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02945657
Brief Title
Pharmacokinetics and Safety of MM36 Topical Ointment 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
June 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medimetriks Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MM36 1% ointment
Arm Type
Experimental
Arm Description
MM36 topical ointment, 1%, applied twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
MM36 topical ointment, 1%
Other Intervention Name(s)
OPA-15406
Intervention Description
Twice daily application for 28 consecutive days
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of MM36
Description
Maximum observed plasma concentration of MM36 on Day 1
Time Frame
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Title
Maximum Observed Plasma Concentration (Cmax) of MM36
Description
Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)
Time Frame
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Title
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
Description
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1
Time Frame
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Title
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
Description
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15
Time Frame
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Title
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
Description
Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1
Time Frame
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Title
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
Description
Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15
Time Frame
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Secondary Outcome Measure Information:
Title
Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
up to 4 weeks
Title
Treatment-Emergent Adverse Events (AEs) According to Severity
Description
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.
Time Frame
up to 4 weeks
Title
Application Site Adverse Events (AEs)
Description
Number of Participants With Application Site Adverse Events (AEs)
Time Frame
up to 4 weeks
Title
Application Site Adverse Events (AEs) According to Severity
Description
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.
Time Frame
up to 4 weeks
Title
Clinically Meaningful Laboratory Test Median Changes From Baseline
Description
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.
Time Frame
Day 29
Title
Clinically Meaningful Vital Sign Median Changes From Baseline
Description
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.
Time Frame
Day 29
Title
Clinically Meaningful ECG Median Changes From Baseline to Day 15
Description
Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.
Time Frame
Day 15
Title
Clinically Meaningful ECG Median Changes From Baseline to Day 29
Description
Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Rosenberg, MD
Organizational Affiliation
Medimetriks Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Medimetriks Investigational Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Medimetriks Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Medimetriks Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Medimetriks Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Medimetriks Investigational Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Medimetriks Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Medimetriks Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Medimetriks Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medimetriks Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Medimetriks Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medimetriks Investigational Site
City
San Pedro Sula
Country
Honduras
Facility Name
Medimetriks Investigational Site
City
Panama City
Country
Panama

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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