An Open-Label, Pilot Pharmacokinetic Study of INCB018424 Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

  • sponsor
    Incyte Corporation
Updated on 8 December 2020
atopic dermatitis
atopic dermatitis/eczema


An Open-Label, Pilot Pharmacokinetic Study of INCB018424 Phosphate Cream in Pediatric Subjects With Atopic Dermatitis


The purpose of this study is to evaluate the safety and tolerability of topical INCB018424 cream applied to pediatric subjects (≥ 12 to 17 years) with atopic dermatitis (AD).

For more information, please contact Incyte Corporation at 1.855.463.3463

Condition ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), ATOPIC DERMATITIS, Dermatitis, Atopic, Dermatite Atopique, Eczéma (Dermatite Atopique), Pediatrics
Clinical Study IdentifierTX153343
SponsorIncyte Corporation
Last Modified on8 December 2020


Yes No Not Sure

Inclusion Criteria

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
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