Solumed Centrum Medyczne | Poznan, Poland
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About
This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
Enrollment
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Inclusion criteria
Exclusion criteria
Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
Concurrent conditions and history of other diseases as follows:
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 cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Any of the following clinical laboratory test results at screening:
Hemoglobin < 10 g/dL.
Liver function tests:
Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation).
Positive serology test results for HIV antibody.
Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
Use of any of the following treatments within the indicated washout period before Day 1:
Note: COVID-19 vaccination is allowed.
• 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), 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 and their frequency remains the same throughout the study.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
225 participants in 5 patient groups, including a placebo group
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Central trial contact
Incyte Corporation Call Center (ex-US); Incyte Corporation Call Center (US)
Data sourced from clinicaltrials.gov
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