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A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

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ClinicalTrials.gov Identifier: NCT04921969
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Ruxolitinib Drug: Vehicle Cream Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)
Actual Study Start Date : July 19, 2021
Estimated Primary Completion Date : October 18, 2023
Estimated Study Completion Date : October 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Ruxolitinib (1.5% Cream)
Study drug will be administered twice daiily.
Drug: Ruxolitinib
The study cream will be applied topically twice a day for up to 52 weeks.
Other Name: Jakafi

Experimental: Ruxolitinib (0.75% cream)
Study drug will be administered twice daily.
Drug: Ruxolitinib
The study cream will be applied topically twice a day for up to 52 weeks.
Other Name: Jakafi

Placebo Comparator: Vehicle Cream
Vehicle cream will be administered twice daily.
Drug: Vehicle Cream
Matching vehicle cream will be applied topically twice a day for up to 8 weeks.
Other Name: Placebo




Primary Outcome Measures :
  1. Proportion of Participants who achieve Investigator's Global Assessment Treatment Success (IGA-TS) [ Time Frame: Week 8 ]
    Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.


Secondary Outcome Measures :
  1. Proportion of participants who achieve Eczema Area and Severity Index (EASI75) [ Time Frame: Week 8 ]
    Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.

  2. Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score from baseline to Week 8. [ Time Frame: Week 8 ]
    NRS assessments will be reported by the participants ≥6 years of age, via Diary once daily beginning on the day of screening through the last application of study drug during the VC period. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).

  3. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 61 weeks ]
    Adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug/treatment.

  4. Proportion of participants who achieve IGA-TS at Weeks 2 and 4. [ Time Frame: Week 2 and 4 ]
    Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.

  5. Proportion of participants with a ≥ 4-point improvement in Itch NRS score from baseline to Weeks 2 and 4. [ Time Frame: Weeks 2 and 4 ]
    NRS assessments will be reported by the participants ≥6 years of age, via Diary once daily beginning on the day of screening through the last application of study drug during the VC period. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).

  6. Proportion of participants who achieve EASI75 at Weeks 2 and 4. [ Time Frame: Weeks 2 and 4 ]
    Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.

  7. Time to achieve Itch NRS score improvement of at least 2 or 4 points. [ Time Frame: Week 8 ]
    Defined as time taken by participants to achieve a 2 or 4 point improvement on itch NRS scale. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
  • Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).
  • Participants with IGA score of 2 to 3 at the screening and baseline visits.
  • Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits.
  • For children aged 6 years to < 12 years, baseline itch NRS score ≥ 4.
  • Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.
  • Participants with at least 1 target lesion that measures at least 5 cm2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia.
  • Willingness to avoid pregnancy or fathering a child for the duration of study participation.

Exclusion Criteria:

  • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.
  • Concurrent conditions and history of other diseases as follows:

    1. Immunocompromised
    2. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
    3. Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
    4. Any other concomitant skin disorder, pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety.
    5. Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
    6. Other types of eczema.
    7. Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Use of any of the following treatments within the indicated washout period before the baseline visit:

    1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
    2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
    3. 2 weeks - immunizations with activated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: Live vaccines are not recommended during the VC period.
    4. 1 week - use of topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical 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.
  • Participants who have previously received JAK inhibitors, systemic or topical. -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.-
  • Positive serology test results at screening for HIV antibody.
  • 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.
  • Inadequate venous access in nonlesional areas for laboratory blood draws.
  • In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.
  • Employees of the sponsor or investigator or otherwise dependents of them.

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): NCT04921969


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
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United States, Arizona
Desert Sky Dermatology Recruiting
Gilbert, Arizona, United States, 85295
United States, Florida
Acevedo Clinical Research Recruiting
Miami, Florida, United States, 33142
United States, Ohio
Ohio Pediatric Research Association Recruiting
Dayton, Ohio, United States, 45414
United States, Texas
Progressive Clinical Research Recruiting
San Antonio, Texas, United States, 78213
United States, Virginia
Pi Coor Clinical Research Llc Recruiting
Burke, Virginia, United States, 22015
Clinical Research Partners Llc Recruiting
Richmond, Virginia, United States, 23220
United States, Washington
Dermatology Specialists of Spokane Recruiting
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04921969    
Other Study ID Numbers: INCB 18424-305
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
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
Ruxolitinib
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