Trial Outcomes & Findings for Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis (NCT NCT02945657)

NCT ID: NCT02945657

Last Updated: 2018-11-19

Results Overview

Maximum observed plasma concentration of MM36 on Day 1

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
• Results posted on: 2018-11-19

Participant Flow

Participant milestones

Measure	MM36 Topical Ointment, 1% MM36 topical ointment, 1%, applied twice daily for 28 days
Overall Study STARTED	32
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	MM36 Topical Ointment, 1% MM36 topical ointment, 1%, applied twice daily for 28 days
Overall Study Adverse Event	1
Overall Study Withdrawal by Parent/Guardian	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MM36 Topical Ointment, 1% n=32 Participants MM36 topical ointment, 1%, applied twice daily for 28 days
Age, Categorical <=18 years	32 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	7.9 years STANDARD_DEVIATION 4.33 • n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants
Race (NIH/OMB) More than one race	7 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	15 participants n=93 Participants
Region of Enrollment Panama	11 participants n=93 Participants
Region of Enrollment Honduras	6 participants n=93 Participants
Percentage of Body Surface Area (BSA) Involved	43.7 % STANDARD_DEVIATION 13.25 • n=93 Participants

PRIMARY outcome

Timeframe: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

Population: Pharmacokinetic (PK) population included participants in the Safety Population with PK Data

Maximum observed plasma concentration of MM36 on Day 1

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Maximum Observed Plasma Concentration (Cmax) of MM36	23.1 ng/mL Standard Deviation 23.4

PRIMARY outcome

Timeframe: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

Population: Pharmacokinetic (PK) population included participants in the Safety Population with PK Data

Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Maximum Observed Plasma Concentration (Cmax) of MM36	16.9 ng/mL Standard Deviation 21.9

PRIMARY outcome

Timeframe: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

Population: Pharmacokinetic (PK) population included participants in the Safety Population with PK Data

Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Time of Maximum Observed Plasma Concentration (Tmax) of MM36	4.22 hours Standard Deviation 2.02

PRIMARY outcome

Timeframe: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

Population: Pharmacokinetic (PK) population included participants in the Safety Population with PK Data

Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Time of Maximum Observed Plasma Concentration (Tmax) of MM36	3.80 hours Standard Deviation 2.24

PRIMARY outcome

Timeframe: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

Population: Pharmacokinetic (PK) population included participants in the Safety Population with PK Data

Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36	107 ng·hr/mL Standard Deviation 94.1

PRIMARY outcome

Timeframe: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

Population: Pharmacokinetic (PK) population included participants in the Safety Population with PK Data

Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36	86.2 ng·hr/mL Standard Deviation 79.6

SECONDARY outcome

Timeframe: up to 4 weeks

Population: Safety population included all subjects in the Intent to treat (ITT) population who had at least one post-baseline safety assessment

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) No AE	24 participants
Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AE	7 participants
Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	0 participants

SECONDARY outcome

Timeframe: up to 4 weeks

Population: Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment

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.

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Treatment-Emergent Adverse Events (AEs) According to Severity None	24 participants
Treatment-Emergent Adverse Events (AEs) According to Severity Mild	6 participants
Treatment-Emergent Adverse Events (AEs) According to Severity Severe	0 participants
Treatment-Emergent Adverse Events (AEs) According to Severity Moderate	1 participants

SECONDARY outcome

Timeframe: up to 4 weeks

Population: Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment

Number of Participants With Application Site Adverse Events (AEs)

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Application Site Adverse Events (AEs) Application site rash	1 participants
Application Site Adverse Events (AEs) None	29 participants
Application Site Adverse Events (AEs) Application site pain	1 participants

SECONDARY outcome

Timeframe: up to 4 weeks

Population: Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment

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.

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Application Site Adverse Events (AEs) According to Severity None	29 participants
Application Site Adverse Events (AEs) According to Severity Mild	1 participants
Application Site Adverse Events (AEs) According to Severity Moderate	1 participants
Application Site Adverse Events (AEs) According to Severity Severe	0 participants

SECONDARY outcome

Timeframe: Day 29

Population: Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment

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.

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Clinically Meaningful Laboratory Test Median Changes From Baseline	0 participants

SECONDARY outcome

Timeframe: Day 29

Population: Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment

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.

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Clinically Meaningful Vital Sign Median Changes From Baseline	0 participants

SECONDARY outcome

Timeframe: Day 15

Population: Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment

Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Clinically Meaningful ECG Median Changes From Baseline to Day 15	0 participants

SECONDARY outcome

Timeframe: Day 29

Population: Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment

Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

Outcome measures

Measure	MM36 Topical Ointment, 1% n=31 Participants MM36 topical ointment, 1%, applied twice daily for 15 days
Clinically Meaningful ECG Median Changes From Baseline to Day 29	0 participants

Adverse Events

MM36 Topical Ointment, 1%

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MM36 Topical Ointment, 1% n=31 participants at risk MM36 topical ointment, 1%, applied twice daily for 15 days
Gastrointestinal disorders Vomiting	3.2% 1/31 • Number of events 1 • up to 4 weeks
General disorders Application site pain	3.2% 1/31 • Number of events 1 • up to 4 weeks
General disorders Application site rash	3.2% 1/31 • Number of events 1 • up to 4 weeks
General disorders Influenza like illness	3.2% 1/31 • Number of events 1 • up to 4 weeks
General disorders Pyrexia	3.2% 1/31 • Number of events 1 • up to 4 weeks
Infections and infestations Nasopharyngitis	3.2% 1/31 • Number of events 1 • up to 4 weeks
Infections and infestations Tonsillitis	3.2% 1/31 • Number of events 1 • up to 4 weeks
Infections and infestations Upper respiratory tract infection	3.2% 1/31 • Number of events 1 • up to 4 weeks
Investigations Eosinophil count increased	3.2% 1/31 • Number of events 1 • up to 4 weeks

Additional Information

Director of Clinical Development

Medimetriks Pharmaceuticals, Inc.

Phone: 973-882-7512

Email: clinicaltrials.gov_inquiries@medimetriks.com

Results disclosure agreements

• Principal investigator is a sponsor employee Since the study is part of a multi-center study and an independent publication that will incorporate multi-center trial data is anticipated, Institution agrees not to independently publish its results of the study if such publication is published within 12 months from completion of the study. The Institution and Investigator agree not to publish the results of the study without prior written consent of the Sponsor, which consent may be withheld by Sponsor for any or no reason.
• Publication restrictions are in place

Restriction type: OTHER