A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

November 9, 2020 updated by: Incyte Corporation

An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with atopic dermatitis (AD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four additional cohorts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35244
        • Cahaba Dermatology
    • Arizona
      • Gilbert, Arizona, United States, 85295
        • Desert Sky Dermatology
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
    • California
      • Anaheim, California, United States, 92801
        • Orange County Research Center
      • Los Angeles, California, United States, 90027
        • Children'S Hospital Los Angeles Specialt
      • San Diego, California, United States, 92123
        • Rady Children's Hospital - San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Largo, Florida, United States, 33770
        • Olympian Clinical Research
      • Miami, Florida, United States, 33145
        • Floridian Research Institute Llc
      • Miami, Florida, United States, 33142
        • Acevedo Clinical Research
      • Miami, Florida, United States, 33174
        • RM Medical Research Inc
      • Tampa, Florida, United States, 33609
        • Olympian Clinical Research
    • Georgia
      • Columbus, Georgia, United States, 31904
        • IACT Health
    • Idaho
      • Boise, Idaho, United States, 83713
        • Advanced Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clincal Trials Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson, Md, Pllc
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates Llc
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research - ClinEdge - PPDS
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
    • Texas
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric subjects aged ≥ 2 to 17 years, inclusive
  • Subjects diagnosed with AD as defined by the Hanifin and Rajka criteria.
  • Subjects with active inflammation associated with AD.
  • Subjects with an Investigator's Global Assessment (IGA) score of at least 2 at screening and baseline.
  • Subjects with body surface area (BSA) of AD involvement of 8% to 20% at screening and baseline.
  • Subjects who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
  • Subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation.
  • Written informed consent of the parent(s) or legal guardian and a verbal or written assent from the subject when possible.

Exclusion Criteria:

  • Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline.
  • Use of topical treatments for AD (other than bland moisturizer such as Eucerin® cream) within 2 weeks of baseline.

  • Concurrent conditions and history of other diseases:

    • Presence of AD lesions only on the hands or feet without a history of involvement of other classical areas of involvement such as the face or the flexural folds.
    • Other types of eczema.
    • Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton Syndrome, or psoriasis), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise subject safety.
    • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome) or have a history of malignant disease within 5 years before the baseline visit.
    • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit.
    • Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit.
    • Chronic asthma requiring more than 880 μg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
  • Subjects with cytopenias at screening per protocol-defined criteria.

  • Use of the following medications:

    • Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
    • Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
    • Subjects who have previously received JAK inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
    • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
    • Use of any prohibited medications within 14 days or 5 half-lives (whichever is longer) of the baseline visit.
  • Parent or legal guardian who, in the opinion of the investigator, is unable or unlikely to comply with the administration schedule and study evaluations or are unable or unwilling to apply the study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Ruxolitinib phosphate cream 0.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Names:
  • INCB018424
Experimental: Cohort 2
Ruxolitinib phosphate cream 1.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Names:
  • INCB018424
Experimental: Cohort 3
Ruxolitinib phosphate cream 0.75%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Names:
  • INCB018424
Experimental: Cohort 4
Ruxolitinib phosphate cream 1.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Names:
  • INCB018424
Experimental: Cohort 5
Ruxolitinib phosphate cream 0.75%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Names:
  • INCB018424
Experimental: Cohort 6
Ruxolitinib phosphate cream 1.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Names:
  • INCB018424

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants with treatment-emergent adverse events (TEAEs)
Time Frame: Screening through 30-37 days after end of treatment, up to approximately 12 weeks.
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first application of study drug.
Screening through 30-37 days after end of treatment, up to approximately 12 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma concentrations of ruxolitinib for Cohorts 1 and 2
Time Frame: Day 1, Day 15, and Day 29
Venous blood samples will be collected to assess the PK of ruxolitinib .
Day 1, Day 15, and Day 29
Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6
Time Frame: Day 1, Day 10, and Day 29
Venous blood samples will be collected to assess the PK of ruxolitinib .
Day 1, Day 10, and Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Kuligowski, MD, PhD, MBA, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCB 18424-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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