Clinical trial NCT02945657: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Medimetriks Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of MM36
timeFrame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of MM36
timeFrame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
measure: Time of Maximum Observed Plasma Concentration (Tmax) of MM36
timeFrame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
measure: Time of Maximum Observed Plasma Concentration (Tmax) of MM36
timeFrame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
measure: Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
timeFrame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
measure: Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
timeFrame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Secondary outcomes:
measure: Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: up to 4 weeks
measure: Treatment-Emergent Adverse Events (AEs) According to Severity
timeFrame: up to 4 weeks
measure: Application Site Adverse Events (AEs)
timeFrame: up to 4 weeks
measure: Application Site Adverse Events (AEs) According to Severity
timeFrame: up to 4 weeks
measure: Clinically Meaningful Laboratory Test Median Changes From Baseline
timeFrame: Day 29
measure: Clinically Meaningful Vital Sign Median Changes From Baseline
timeFrame: Day 29
measure: Clinically Meaningful ECG Median Changes From Baseline to Day 15
timeFrame: Day 15
measure: Clinically Meaningful ECG Median Changes From Baseline to Day 29
timeFrame: Day 29
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Medimetriks Investigational Site
state: California
city: Irvine
country: United States
facility: Medimetriks Investigational Site
state: California
city: San Diego
country: United States
facility: Medimetriks Investigational Site
state: California
city: Miami
country: United States
facility: Medimetriks Investigational Site
state: Florida
city: Saint Joseph
country: United States
facility: Medimetriks Investigational Site
state: Missouri
city: Portland
country: United States
facility: Medimetriks Investigational Site
state: Oregon
city: Austin
country: United States
facility: Medimetriks Investigational Site
state: Texas
city: Houston
country: United States
facility: Medimetriks Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Medimetriks Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Medimetriks Investigational Site
state: Washington
city: San Pedro Sula
country: Honduras
facility: Medimetriks Investigational Site
city: Panama City
country: Panama
facility: Medimetriks Investigational Site
Study officials:
affiliation: Medimetriks Pharmaceuticals, Inc
name: Noah Rosenberg, MD
role: STUDY_DIRECTOR
References: