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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02945657
Other study ID # MEDI-MM36-206
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2016
Est. completion date June 8, 2017

Study information

Verified date November 2018
Source Medimetriks Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 8, 2017
Est. primary completion date June 8, 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
MM36 topical ointment, 1%
Twice daily application for 28 consecutive days

Locations

Country Name City State
Honduras Medimetriks Investigational Site San Pedro Sula
Panama Medimetriks Investigational Site Panama City
United States Medimetriks Investigational Site Austin Texas
United States Medimetriks Investigational Site Fremont California
United States Medimetriks Investigational Site Houston Texas
United States Medimetriks Investigational Site Irvine California
United States Medimetriks Investigational Site Miami Florida
United States Medimetriks Investigational Site Norfolk Virginia
United States Medimetriks Investigational Site Portland Oregon
United States Medimetriks Investigational Site Saint Joseph Missouri
United States Medimetriks Investigational Site San Diego California
United States Medimetriks Investigational Site Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Medimetriks Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Honduras,  Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary Application Site Adverse Events (AEs) Number of Participants With Application Site Adverse Events (AEs) up to 4 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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