A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT06832618
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    The study cream will be applied topically as defined in the protocol for each period.
  • Vehicle Cream — DRUG
    Matching vehicle cream will be applied topically as defined in the protocol for each period.

Study Details

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.

Key Dates

First listed
Feb 18, 2025
Start date
Jun 17, 2025
Status verified
Jun 2026
Primary completion
Jul 13, 2026
Completion
May 18, 2028

Study Design

Enrollment
159 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream)
    Study drug will be administered twice daily.
  • Placebo Comparator: VC Period: Vehicle Cream
    Matching vehicle cream will be administered twice daily.
  • Experimental: Disease Control (DC) Period: Ruxolitinib (1.5% Cream)
    Study drug will be administered twice weekly.
  • Placebo Comparator: DC Period: Vehicle Cream
    Matching vehicle cream will be administered twice weekly.
  • Experimental: DC Period: Open Label - Ruxolitinib (1.5% Cream)
    Study drug will be administered twice daily to treat Disease Exacerbations.
  • Experimental: Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream)
    Study drug will be administered twice daily.

Primary Outcome Measure

VC Period: Binary response status of Eczema Area and Severity Index 75 (EASI75) [ Time Frame: VC Week 8 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Clinical Research Center of AlabamaBirminghamAlabama35209-
Saguaro DermatologyPhoenixArizona85008-
National Jewish HealthDenverColorado80206-
Encore Medical Research, Llc HollywoodHollywoodFlorida33024-
Lane Dermatology and Dermatologic SurgeryColumbusGeorgia31904-
Cleaver Medical GroupCummingGeorgia30040-
Treasure Valley Medical ResearchBoiseIdaho83706-
Sneeze Wheeze and Itch Associates LlcNormalIllinois61761-
Endeavor Health Medical GroupSkokieIllinois60077-
Raven Clinical ResearchMarriottsvilleMaryland21104-
Oakland Hills Dermatology PcAuburn HillsMichigan48326-
Henry Ford Health SystemDetroitMichigan48202-
University of Mississippi Medical CenterJacksonMississippi39216-
Red River Research PartnersBolivarMissouri65613-
Medisearch Clinical TrialsSaint JosephMissouri64506-
University of Rochester Medical CenterRochesterNew York14620-
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45229-
University of Texas Physicians - Bellaire StationBellaireTexas77401-
Frontier DermatologyMill CreekWashington98012-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Clinical Research Center of Alabama· Birmingham, ALSaguaro Dermatology· Phoenix, AZNational Jewish Health· Denver, COEncore Medical Research, Llc Hollywood· Hollywood, FLLane Dermatology and Dermatologic Surgery· Columbus, GACleaver Medical Group· Cumming, GA

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