Atopic DermatitisPhase 2NCT02945657
Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
A Phase 2 study testing MM36 topical ointment, 1% in people with Atopic Dermatitis, run by Medimetriks Pharmaceuticals, Inc at 12 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- MM36 topical ointment, 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Oct 2016to 8 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
Medimetriks Investigational Site
Austin, Texas, 78759
Medimetriks Investigational Site
Fremont, California, 94538
Medimetriks Investigational Site
Houston, Texas, 77030
Medimetriks Investigational Site
Irvine, California, 92697
Medimetriks Investigational Site
Miami, Florida, 33125
Medimetriks Investigational Site
Norfolk, Virginia, 23502
Medimetriks Investigational Site
Portland, Oregon, 97239
Medimetriks Investigational Site
Saint Joseph, Missouri, 64506
Medimetriks Investigational Site
San Diego, California, 92123
Medimetriks Investigational Site
Spokane, Washington, 99202
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- MM36 topical ointment, 1%
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM36 topical ointment, 1%Drug
Also called OPA-15406
Twice daily application for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| MM36 1% ointment | Experimental | MM36 topical ointment, 1%, applied twice daily for 28 days Receives: Drug: MM36 topical ointment, 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of MM36
Maximum observed plasma concentration of MM36 on Day 1
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
Application Site Adverse Events (AEs)
Number of Participants With Application Site Adverse Events (AEs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medimetriks Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noah Rosenberg, MD, Study director, Medimetriks Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945657
- Sponsor's protocol ID
- MEDI-MM36-206
- Status last verified
- Nov 2018
- First submitted
- 21 Oct 2016
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02945657
- Acronym / sponsor ID
- MEDI-MM36-206
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medimetriks Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 19 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MM36 1% ointment | Experimental | Drug: MM36 topical ointment, 1%MM36 topical ointment, 1%, applied twice daily for 28 days |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM36 topical ointment, 1%Also: OPA-15406Twice daily application for 28 consecutive days | Drug | MM36 1% ointment |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of MM36
Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Maximum observed plasma concentration of MM36 on Day 1
Maximum Observed Plasma Concentration (Cmax) of MM36
Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
Time frame: 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 on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
Time frame: 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 on Day 15
8 secondary outcomes
Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 4 weeks
Treatment-Emergent Adverse Events (AEs) According to Severity
Time frame: up to 4 weeks
Application Site Adverse Events (AEs)
Time frame: up to 4 weeks
Application Site Adverse Events (AEs) According to Severity
Time frame: up to 4 weeks
Clinically Meaningful Laboratory Test Median Changes From Baseline
Time frame: Day 29
Clinically Meaningful Vital Sign Median Changes From Baseline
Time frame: Day 29
Clinically Meaningful ECG Median Changes From Baseline to Day 15
Time frame: Day 15
Clinically Meaningful ECG Median Changes From Baseline to Day 29
Time frame: Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Rosenberg, MD study director
Medimetriks Pharmaceuticals, Inc
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MM36 topical ointment, 1% in people with Atopic Dermatitis, run by Medimetriks Pharmaceuticals, Inc at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Honduras, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of MM36 (time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.