NCT02945657|CompletedPhase 2ResultsDMC

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

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

Medimetriks Pharmaceuticals, Inc ClinicalTrials.gov

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1 other identifier

MEDI-MM36-206

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredOct 2016

StartedOct 2016

CompletionJun 2017

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Oct 2016

Shorter than P25 for phase_2

Geographic Reach

3 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

October 1, 2016

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

November 19, 2018

Completed

Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

October 21, 2016

Results QC Date

October 16, 2018

Last Update Submit

November 14, 2018

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (6)

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
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
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
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
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
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 Outcomes (8)

Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
up to 4 weeks
Treatment-Emergent Adverse Events (AEs) According to Severity
up to 4 weeks
Application Site Adverse Events (AEs)
up to 4 weeks
Application Site Adverse Events (AEs) According to Severity
up to 4 weeks
Clinically Meaningful Laboratory Test Median Changes From Baseline
Day 29
+3 more secondary outcomes

Study Arms (1)

MM36 1% ointment

EXPERIMENTAL

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

Drug: MM36 topical ointment, 1%

Interventions

MM36 topical ointment, 1%DRUG

Twice daily application for 28 consecutive days

Also known as: OPA-15406

MM36 1% ointment

Eligibility Criteria

Age2 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.