Atopic DermatitisPhase 1NCT03257644
A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
A Phase 1 study testing Ruxolitinib phosphate cream in people with Atopic Dermatitis, run by Incyte Corporation at 23 sites in United States.
Trial summary
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). 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?
- Ruxolitinib phosphate cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 23 sitesUnited States
- Study dates
- 21 Sep 2017to 7 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Orange County Research Center
Anaheim, California, 92801
David Fivenson, Md, Pllc
Ann Arbor, Michigan, 48103
Advanced Clinical Research
Boise, Idaho, 83713
Northwestern University
Chicago, Illinois, 60611
Iact Health
Columbus, Georgia, 31904
Ohio Pediatric Research Association
Dayton, Ohio, 45414
National Jewish Health
Denver, Colorado, 80206
Desert Sky Dermatology
Gilbert, Arizona, 85295
Cyn3Rgy Research - Clinedge - Ppds
Gresham, Oregon, 97030
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Cahaba Dermatology
Hoover, Alabama, 35244
Olympian Clinical Research
Largo, Florida, 33770
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Children'S Hospital Los Angeles Specialt
Los Angeles, California, 90027
Acevedo Clinical Research
Miami, Florida, 33142
Floridian Research Institute Llc
Miami, Florida, 33145
Rm Medical Research Inc
Miami, Florida, 33174
The Indiana Clincal Trials Center
Plainfield, Indiana, 46168
Wake Research Associates Llc
Raleigh, North Carolina, 27612
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Rady Children'S Hospital - San Diego
San Diego, California, 92123
Olympian Clinical Research
Tampa, Florida, 33609
About this study
Official title: 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).
Read the detailed description
Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four additional cohorts.
- Conditions
- Atopic Dermatitis
- Being tested
- Ruxolitinib phosphate cream
- Keywords
- Atopic dermatitis, Janus kinase (JAK) inhibitor, pediatric, inflammation
- Medical subject headings
- Dermatitis, Atopic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib phosphate creamDrug
Also called INCB018424
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Ruxolitinib phosphate cream 0.5%. Receives: Drug: Ruxolitinib phosphate cream |
| Cohort 2 | Experimental | Ruxolitinib phosphate cream 1.5%. Receives: Drug: Ruxolitinib phosphate cream |
| Cohort 3 | Experimental | Ruxolitinib phosphate cream 0.75%. Receives: Drug: Ruxolitinib phosphate cream |
| Cohort 4 | Experimental | Ruxolitinib phosphate cream 1.5%. Receives: Drug: Ruxolitinib phosphate cream |
| Cohort 5 | Experimental | Ruxolitinib phosphate cream 0.75%. Receives: Drug: Ruxolitinib phosphate cream |
| Cohort 6 | Experimental | Ruxolitinib phosphate cream 1.5%. Receives: Drug: Ruxolitinib phosphate cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with treatment-emergent adverse events (TEAEs)
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.
Measured: Screening through 30-37 days after end of treatment, up to approximately 12 weeks.
Secondary outcomes (2)
Plasma concentrations of ruxolitinib for Cohorts 1 and 2
Venous blood samples will be collected to assess the PK of ruxolitinib .
Measured: Day 1, Day 15, and Day 29
Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6
Venous blood samples will be collected to assess the PK of ruxolitinib .
Measured: Day 1, Day 10, and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start21 Sep 2017
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kuligowski, MD, PhD, MBA, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257644
- Sponsor's protocol ID
- INCB 18424-102
- Status last verified
- Nov 2020
- First submitted
- 18 Aug 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung DYM, Paller AS, Zaenglein AL, Tom WL, Ong PY, Venturanza ME, Kuligowski ME, Li Q, Gong X, Lee MS. Safety, pharmacokinetics, and efficacy of ruxolitinib cream in children and adolescents with atopic dermatitis. Ann Allergy Asthma Immunol. 2023 Apr;130(4):500-507.e3. doi: 10.1016/j.anai.2022.12.033. Epub 2022 Dec 28.
PubMed 36586583
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03257644
- Acronym / sponsor ID
- INCB 18424-102
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Janus kinase (JAK) inhibitor, pediatric, inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
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 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).
Detailed description
Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four additional cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Ruxolitinib phosphate creamRuxolitinib phosphate cream 0.5%. |
| Cohort 2 | Experimental | Drug: Ruxolitinib phosphate creamRuxolitinib phosphate cream 1.5%. |
| Cohort 3 | Experimental | Drug: Ruxolitinib phosphate creamRuxolitinib phosphate cream 0.75%. |
| Cohort 4 | Experimental | Drug: Ruxolitinib phosphate creamRuxolitinib phosphate cream 1.5%. |
| Cohort 5 | Experimental | Drug: Ruxolitinib phosphate creamRuxolitinib phosphate cream 0.75%. |
| Cohort 6 | Experimental | Drug: Ruxolitinib phosphate creamRuxolitinib phosphate cream 1.5%. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
- Subjects with cytopenias at screening per protocol-defined criteria.
- Use of the following medications:
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 |
|---|---|---|
| Ruxolitinib phosphate creamAlso: INCB018424Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
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.
2 secondary outcomes
Plasma concentrations of ruxolitinib for Cohorts 1 and 2
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 36586583Leung DYM, Paller AS, Zaenglein AL, Tom WL, Ong PY, Venturanza ME, Kuligowski ME, Li Q, Gong X, Lee MS. Safety, pharmacokinetics, and efficacy of ruxolitinib cream in children and adolescents with atopic dermatitis. Ann Allergy Asthma Immunol. 2023 Apr;130(4):500-507.e3. doi: 10.1016/j.anai.2022.12.033. Epub 2022 Dec 28.
- Individual participant dataSharing planned: No
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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.
Michael Kuligowski, MD, PhD, MBA study director
Incyte Corporation
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib phosphate cream in people with Atopic Dermatitis, run by Incyte Corporation at 23 sites in United States.
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 8 inclusion and 18 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participants with treatment-emergent adverse events (TEAEs) (time frame: Screening through 30-37 days after end of treatment, up to approximately 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257644, which also lists 1 linked publication.
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 10 Nov 2020.