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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2024
  • participants needed
    250
  • sponsor
    Incyte Corporation
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Updated on 7 October 2022
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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%).

Details
Condition Atopic Dermatitis
Treatment Ruxolitinib, Vehicle cream
Clinical Study IdentifierNCT04921969
SponsorIncyte Corporation
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

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
Immunocompromised
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit
Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit
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
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
Other types of eczema
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
5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab)
4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus)
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
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
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