Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis

Study Identifier
M25-145
CT.gov Identifier
NCT06701331
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
  • Placebo
  • Upadacitinib
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    2 - 11 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * A minimum weight of 10 kg and weight and height ≥ -2.0 SD for their age according to Japanese standard growth charts at the Baseline visit. * Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline. * Eczema Area and Severity Index (EASI) score ≥ 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score ≥ 3; ≥ 10% body surface area (BSA) of AD involvement at the Baseline visit; and Baseline weekly average of daily WIS or WSI-NRS ≥ 4. * Participant has applied a topical, additive-free, bland emollient or moisturizer twice daily for at least 7 days before the Baseline visit. * Documented history (within 6 months of the Baseline visit) of inadequate response or intolerance to topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) or a systemic immunomodulating therapy, or medical inadvisability of available systemic therapy (e.g., because of important side effects or safety risks).
    Exclusion Criteria:
    * Participants that have current and/or history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit or that would interfere with the appropriate assessment of AD lesions. * Participants that have used topical treatments for AD (except for topical emollient or moisturizer treatments) including but not limited to TCS, TCI, or topical PDE-4 inhibitors, within 7 days of the Baseline visit or any the following prohibited AD treatments within the specified timeframes below prior to the Baseline visit: * Systemic therapy for AD, including but not limited to corticosteroids and cyclosporine, within 4 weeks; * Targeted biologic treatments within 5 half-lives (if known) or within 12 weeks, whichever is longer; * Phototherapy treatment, laser therapy, tanning booth use, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.

    Protocol Summary

    Pediatric atopic dermatitis (AD), also known as childhood eczema, is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to assess the change in disease activity (Efficacy) and to assess the safety of upadacitinib in combination with topical corticosteroids (TCS) in pediatric participants 2 to 11 years of age in Japan with moderate to severe AD who are candidates for systemic therapy.

    Upadacitinib is approved for the treatment of moderate to severe AD in adults and adolescents 12 years of age and older in many countries, including Japan. This study comprises a 35-day screening period; a 12-week, randomized, double-blind treatment period where there will be a 1 in 2 chance that a participant is assigned placebo. This will be followed by an open-label upadacitinib treatment period up to Week 52.

    Around 98 participants will be enrolled in the study at approximately 35 sites in Japan.

    Participants will receive upadacitinib oral tablets, or matching placebo, once daily (or an adult equivalent oral solution dose twice a day) for up to 52 weeks.

    There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Central Clinic - Nagoya /ID# 269205
    Nagoya, Aichi-ken, Japan, 464-0821
    Status
    Not applicable
    Location
    Fujita Health University Hospital /ID# 269201
    Toyoake, Aichi-ken, Japan, 470-1192
    Status
    Not applicable
    Location
    Miyata Dermatology Clinic /ID# 269200
    Matsudo-Shi, Chiba, Japan, 271-0092
    Status
    Not applicable
    Location
    Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192
    Fukuoka, Fukuoka, Japan, 814-0171
    Status
    Not applicable
    Location
    Saruta Dermatology Clinic /ID# 270416
    Fukuoka, Fukuoka, Japan, 819-0042
    Status
    Not applicable
    Location
    Tokunaga Skin Clinic /ID# 270189
    Kasuga-shi, Fukuoka, Japan, 816-0813
    Status
    Not applicable
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