INCB 18424-304: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE-AD2) for 304

  • STATUS
    Recruiting
Updated on 25 August 2021
DERMRESEARCH (6.2 mi away) Contact
+10 other location
atopic dermatitis
eczema
dermatitis
atopic dermatitis/eczema

Summary

A Phase 3, randomized (2:2:1), double-blind, 8-week vehicle control efficacy and safety study of ruxolitinib followed by a randomized, double-blind, 44-week long term safety (LTS) extension period. 

In the LTS period,  participants initially randomized to vehicle will receive either ruxolitinib 0.75% or 1.5% cream.  All participants will have follow-up assessments 30 (+7) days after the last application of study drug.

 

Description

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 IdentifierTX222547
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years
Participants diagnosed with AD as defined by the Hanifin and Rajka criteria
AD duration of at least 2 years
Participants with an IGA score of 2 to 3 at screening and baseline (VC period) and 0 to 4 at Week 8 (long-term safety period)
Participants with % BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline (VC period) and 0% to 20% at Week 8 (long-term safety period)
Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit
Participants who have at least 1 "target lesion" that measures approximately 10 cm2 or more at screening and baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia
Willingness to avoid pregnancy or fathering of children

Exclusion Criteria

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
Immunocompromised
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline
Active acute bacterial, fungal, or viral skin infection within 1 week before baseline
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 classical areas of involvement such as the face or the folds
Other types of eczema
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 baseline
half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab)
weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus)
weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted)
week - use of other topical treatments for AD (other than bland emollients). 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
Participants who have previously received JAK inhibitors, systemic or topical
Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to baseline 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
Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Pregnant or lactating participants, or those considering pregnancy
History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments
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
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