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Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05456529
Recruitment Status : Recruiting
First Posted : July 13, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis (AD) Drug: Ruxolitinib Cream Phase 3

Detailed Description:
The study comprises of a 8 week continuous treatment period followed by 44 week Long Term Safety (LTS) period and 30 days safety follow up period. During Continuous treatment period all lesions identified at baseline will be treated and during LTS period only active lesions will be treated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, One-Year Safety Study of Ruxolitinib Cream in Adolescents (Ages ≥ 12 Years to < 18 Years) With Atopic Dermatitis
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : March 20, 2024
Estimated Study Completion Date : March 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Ruxolitinib
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.
Drug: Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.
Other Name: INCB18424 cream




Primary Outcome Measures :
  1. Number of Treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline up to 56 weeks ]
    TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.


Secondary Outcome Measures :
  1. Number of participants with clinically notable vital sign changes from baseline [ Time Frame: Baseline up to week 52 ]
    Changes in vital signs assessment of blood pressure, pulse, respiration rate, and body temperature.

  2. Number of participants with clinically significant changes from Baseline in height [ Time Frame: Baseline up to week 52 ]
    Changes in height will be assessed.

  3. Number of participants with clinically significant changes from Baseline in weight [ Time Frame: Baseline up to week 52 ]
    Changes in weight will be assessed.

  4. Number of participants with changes from baseline outside the normal range for clinically laboratory parameter values [ Time Frame: Baseline up to week 52 ]
    Laboratory test values outside the normal range will be assessed for severity based on the normal ranges for the clinical reference laboratory.

  5. Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations [ Time Frame: Predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52) ]
    Trough concentration is defined as drug concentration in blood and/or saliva sampling.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.
  • Duration of AD of at least 2 years.
  • Total IGA score of 2 to 3 at the screening and baseline visits.
  • Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits.
  • Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable.
  • Agree to discontinue all agents used to treat AD from screening through the final follow up visit.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
  • Concurrent conditions and history of other diseases
  • Any current and/or history of serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. For example:
  • Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction or stroke within 6 months from Day 1 of study cream application, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mm Hg) unless approved by the medical monitor/sponsor.
  • Current and/or history of malignancy in the 5 years preceding the baseline visit, except for adequately treated, nonmetastatic nonmelanoma skin cancer.
  • Current and/or history of arterial or venous thrombosis, including DVT and PE.
  • Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated.
  • Any of the following clinical laboratory test results at screening:

    1. Hemoglobin < 100 g/L (< 10 g/dL)
    2. Liver function tests:
  • AST or ALT ≥ 2.5 × ULN
  • Total bilirubin > 1.5 × ULN with the exception of Gilbert disease. c. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the CKD Epidemiology Collaboration equation).

    d. Positive serology test results for HIV antibody. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.

  • Use of any of the following treatments within the indicated washout period before baseline:

    1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
    2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
    3. 2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).

      Note: Live-attenuated vaccines are not recommended during the CT period. Note: COVID-19 vaccination is allowed.

    4. 1 week - use of other topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.

Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.

  • Previously received systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
  • Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with a strong CYP3A4 inhibitor.
  • Inability to draw blood for PK analysis from any nonlesional areas.
  • Known allergy or reaction to any component of the study cream formulation.
  • In the opinion of the investigator unable or unlikely to comply with the administration schedule and study evaluations.

Further exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05456529


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
Show Show 35 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Brett Angel, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05456529    
Other Study ID Numbers: INCB 18424-315
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
atopic dermatitis (AD)
adolescents
pruritus
eczema
topical therapy
JAK inhibitor
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases