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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945657
• Other study ID #: MEDI-MM36-206
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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