Study of Ruxolitinib Cream in Children With Atopic Dermatitis

NCT05034822 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB 18424-109
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

pediatric; Atopic dermatitis; ruxolitinib cream; maximum use; open label

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events

  Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first application of study drug

  Up to approximately 61 weeks

Secondary Outcomes (3)

• Concentration of Ruxolitinib in plasma

  Day 1, Weeks 2, 4 and 8

• Plasma Css of Ruxolitinib

  Weeks 2 and 4

• Accumulation ratio of Ruxilitinib

  Day 1, Weeks 2, 4 and 8

Study Arms (1)

Ruxolitinib cream

EXPERIMENTAL

ruxolitinib 1.5% cream will be applied twice daily to all areas of the skin affected by AD

Drug: Ruxolitinib cream

Interventions

Ruxolitinib cream DRUG

Ruxolitinib 1.5% cream applied twice daily.

Also known as: INCB018424 phosphate cream

Ruxolitinib cream

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Incyte Corporation: lead
• Innovaderm Research: collaborator

Study Sites (15)

Desert Sky Dermatology

Gilbert, Arizona, 85295, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Orange County Research Center

Anaheim, California, 92801, United States

Location

Skin Care Research, Llc Scr Hollywood

Hollywood, Florida, 33021, United States

Location

Accel Clinical Research

Lake Mary, Florida, 32746, United States

Location

San Marcus Research Clinic Inc.

Miami Lakes, Florida, 33014, United States

Location

Forward Clinical Trials

Tampa, Florida, 33624, United States

Location

Advanced Medical Research Pc

Sandy Springs, Georgia, 30328, United States

Location

Aeroallergy Research Lab of Savannah

Savannah, Georgia, 31406, United States

Location

Oakland Hills Dermatology Pc

Auburn Hills, Michigan, 48326, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Cyn3Rgy Research - Clinedge - Ppds

Gresham, Oregon, 97030, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Related Publications (1)

• Stein Gold L, Bissonnette R, Forman S, Zaenglein A, Kuo Y, Angel B, Chen X, Kallender H, Paller AS. A Maximum-Use Trial of Ruxolitinib Cream in Children Aged 2-11 Years with Moderate to Severe Atopic Dermatitis. Am J Clin Dermatol. 2025 Mar;26(2):275-289. doi: 10.1007/s40257-024-00909-5. Epub 2025 Jan 6.

  PMID: 39760983 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Haq Nawaz, MD, MPH, MBA, MS

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Images will be taken and masked for privacy
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: December 16, 2021
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)