Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Medimetriks Pharmaceuticals, Inc

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945657


Locations
Layout table for location information
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
Layout table for investigator information
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


Layout table for additonal 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    Key Record Dates
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:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases