A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream–Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 8 December 2020
Investigator
Mayu Frank
Primary Contact
HASSMAN RESEARCH INSTITUTE (361.1 mi away) Contact
+52 other location
atopic dermatitis
dermatitis
atopic dermatitis/eczema

Summary

A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream–Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Description

The purpose of this study is to evaluate the efficacy of each strength of INCB018424 cream once daily or twice daily in subjects with atopic dermatitis compared with vehicle cream.

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Eczéma (Dermatite Atopique), Dermatite Atopique
Clinical Study IdentifierTX151810
SponsorIncyte Corporation
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects diagnosed with AD as defined by the Hanifin and Rajka criteria
Subjects with a history of AD for at least 2 years
Subjects with an IGA score of 2 to 3 at screening and baseline
Subjects with BSA of AD involvement, excluding the face and intertriginous areas, of 3% 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

Exclusion Criteria

Subjects with evidence of active acute or chronic infections
Use of topical treatments for AD within 2 weeks of baseline
Systemic immunosuppressive or immunomodulating drugs within 4 weeks or 5 half-lives of baseline
Subjects with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis)
Subjects with a history of other diseases besides dermatologic disorders
Subjects with cytopenias at screening
Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on dialysis
Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit
Subjects who have previously received Janus kinase inhibitors, systemic or topical
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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