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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM36 1% ointment | Experimental | MM36 topical ointment, 1%, applied twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM36 topical ointment, 1% | Drug | Twice daily application for 28 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Treatment-Emergent Adverse Events (AEs) According to Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah Rosenberg, MD | Medimetriks Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medimetriks Investigational Site | Fremont | California | 94538 | United States | ||
| Medimetriks Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | MM36 Topical Ointment, 1% | MM36 topical ointment, 1%, applied twice daily for 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2017 | Oct 16, 2018 |
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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 |
| Application Site Adverse Events (AEs) | Number of Participants With Application Site Adverse Events (AEs) | up to 4 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Irvine |
| California |
| 92697 |
| United States |
| Medimetriks Investigational Site | San Diego | California | 92123 | United States |
| Medimetriks Investigational Site | Miami | Florida | 33125 | United States |
| Medimetriks Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| Medimetriks Investigational Site | Portland | Oregon | 97239 | United States |
| Medimetriks Investigational Site | Austin | Texas | 78759 | United States |
| Medimetriks Investigational Site | Houston | Texas | 77030 | United States |
| Medimetriks Investigational Site | Norfolk | Virginia | 23502 | United States |
| Medimetriks Investigational Site | Spokane | Washington | 99202 | United States |
| Medimetriks Investigational Site | San Pedro Sula | Honduras |
| Medimetriks Investigational Site | Panama City | Panama |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MM36 Topical Ointment, 1% | MM36 topical ointment, 1%, applied twice daily for 28 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Percentage of Body Surface Area (BSA) Involved | Mean | Standard Deviation | % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of MM36 | Maximum observed plasma concentration of MM36 on Day 1 | Pharmacokinetic (PK) population included participants in the Safety Population with PK Data | Posted | Mean | Standard Deviation | ng/mL | Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1 |
|
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| |||||||||||||||||||||||||
| Primary | Maximum Observed Plasma Concentration (Cmax) of MM36 | Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state) | Pharmacokinetic (PK) population included participants in the Safety Population with PK Data | Posted | Mean | Standard Deviation | ng/mL | 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 | Pharmacokinetic (PK) population included participants in the Safety Population with PK Data | Posted | Mean | Standard Deviation | hours | 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 | Pharmacokinetic (PK) population included participants in the Safety Population with PK Data | Posted | Mean | Standard Deviation | hours | 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 | Pharmacokinetic (PK) population included participants in the Safety Population with PK Data | Posted | Mean | Standard Deviation | ng·hr/mL | 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 | Pharmacokinetic (PK) population included participants in the Safety Population with PK Data | Posted | Mean | Standard Deviation | ng·hr/mL | 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) | Safety population included all subjects in the Intent to treat (ITT) population who had at least one post-baseline safety assessment | Posted | Number | participants | up to 4 weeks |
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| 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. | Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment | Posted | Number | participants | up to 4 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Application Site Adverse Events (AEs) | Number of Participants With Application Site Adverse Events (AEs) | Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment | Posted | Number | participants | 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. | Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment | Posted | Number | participants | 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. | Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment | Posted | Number | participants | 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. | Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment | Posted | Number | participants | 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. | Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment | Posted | Number | participants | 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. | Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment | Posted | Number | participants | Day 29 |
|
|
up to 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MM36 Topical Ointment, 1% | MM36 topical ointment, 1%, applied twice daily for 15 days | 0 | 31 | 0 | 31 | 7 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Development | Medimetriks Pharmaceuticals, Inc. | 973-882-7512 | 524 | clinicaltrials.gov_inquiries@medimetriks.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 30, 2017 | Oct 16, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000711049 | difamilast |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Honduras |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| No AE |
| |||||
| AE |
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| SAE |
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| Title | Denominators | Categories |
|---|
| None |
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| Application site pain |
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| Application site rash |
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