Study of Ruxolitinib Cream in Children With Atopic Dermatitis

Completed · Phase 1

Conditions studied: Atopic Dermatitis

In brief

This is an open-label maximum use trial to evaluate ruxolitinib safety, tolerability and blood levels after its topical application twice daily to affected areas (≥ 35% BSA) in pediatric participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events.

Key facts

Study ID

NCT05034822

Run by

Incyte Corporation

People needed

29

Starts

2021-12-16

Expected to finish

2023-08-07

Last updated by the study team

2023-09-15

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female children aged ≥ 2 years to < 12 years (age at the screening visit).
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
• 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 to screening).
• An IGA score as follows:
• Treatment period: ≥ 2 at the screening and baseline visits.
• LTS period: 0 to 4 at Week 8
• %BSA (excluding the scalp) with AD involvement as follows:
• Treatment period: ≥ 35% at screening and baseline
• LTS period: 0% to 20% at Week 8
• For children aged 6 years to < 12 years, mean Itch NRS score ≥ 4 during the screening period.
• 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.
• At least 1 target lesion that measures approximately 5 cm2 or more at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the face, hands, feet, or genitalia.
• For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of male and female participants who are prepubescent.
• Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible.

You may not qualify if…

• An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to the baseline visit.
• Concurrent conditions and history of other diseases as follows:
• Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome,
• Wiskott-Aldrich syndrome) or 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 2 weeks before the baseline visit.
• Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, impetigo) within 1 week before the baseline visit.
• Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety.
• Other types of eczema.
• Chronic asthma requiring more than 800 μg/day of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
• A medical history of hepatitis B virus or hepatitis C virus infection.
• Any participant on maintenance dialysis.
• Any of the following clinical laboratory test results at screening:
• Cytopenias at screening, defined as follows:
• Hemoglobin < 10 g/dL
• ANC < 1000/µL
• Platelet count < 100,000/µL
• Liver function tests:
• AST or ALT ≥ 2.5 × ULN
• Total bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%).
• Estimated GFR < 30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease equation)
• Positive serology test results at screening for HIV antibody.
• Any other clinically significant laboratory result that, in the opinion of the investigator, pose a significant risk to the participant
• 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).

Where it is running

• Desert Sky Dermatology — Gilbert, Arizona, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Orange County Research Center — Anaheim, California, United States
• Skin Care Research, Llc Scr Hollywood — Hollywood, Florida, United States
• Accel Clinical Research — Lake Mary, Florida, United States
• San Marcus Research Clinic Inc. — Miami Lakes, Florida, United States
• Forward Clinical Trials — Tampa, Florida, United States
• Advanced Medical Research Pc — Sandy Springs, Georgia, United States
• Aeroallergy Research Lab of Savannah — Savannah, Georgia, United States
• Oakland Hills Dermatology Pc — Auburn Hills, Michigan, United States
• Skin Cancer and Dermatology Institute — Reno, Nevada, United States
• Forest Hills Dermatology Group — Forest Hills, New York, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Cyn3Rgy Research - Clinedge - Ppds — Gresham, Oregon, United States
• Progressive Clinical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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