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

Last updated: March 25, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy

Atopic Dermatitis

Skin Infections/disorders

Treatment

Upadacitinib

Placebo

Clinical Study ID

NCT06701331
M25-145
  • Ages 2-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A minimum weight of 10 kg and weight and height ≥ -2.0 SD for their age according toJapanese standard growth charts at the Baseline visit.

  • Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset ofsymptoms at least 6 months prior to Baseline.

  • Eczema Area and Severity Index (EASI) score ≥ 16; validated Investigator GlobalAssessment 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 dailyWIS or WSI-NRS ≥ 4.

  • Participant has applied a topical, additive-free, bland emollient or moisturizertwice daily for at least 7 days before the Baseline visit.

  • Documented history (within 6 months of the Baseline visit) of inadequate response orintolerance to topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) or a systemic immunomodulating therapy, or medical inadvisability of availablesystemic therapy (e.g., because of important side effects or safety risks).

Exclusion

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 theBaseline visit or that would interfere with the appropriate assessment of ADlesions.

  • Participants that have used topical treatments for AD (except for topical emollientor moisturizer treatments) including but not limited to TCS, TCI, or topical PDE-4inhibitors, within 7 days of the Baseline visit or any the following prohibited ADtreatments within the specified timeframes below prior to the Baseline visit:

  • Systemic therapy for AD, including but not limited to corticosteroids andcyclosporine, 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 sunexposure that could affect disease severity or interfere with diseaseassessments within 4 weeks.

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: Upadacitinib
Phase: 3
Study Start date:
December 22, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Central Clinic /ID# 269205

    Nagoya-shi, Aichi 464-0821
    Japan

    Active - Recruiting

  • Fujita Health University Hospital /ID# 269201

    Toyoake, Aichi 470-1192
    Japan

    Active - Recruiting

  • Miyata Dermatology Clinic /ID# 269200

    Matsudo-Shi, Chiba 271-0092
    Japan

    Active - Recruiting

  • Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192

    Fukuoka-shi, Fukuoka 814-0171
    Japan

    Active - Recruiting

  • Saruta Dermatology Clinic /ID# 270416

    Fukuoka-shi, Fukuoka 819-0043
    Japan

    Active - Recruiting

  • Tokunaga Skin Clinic /ID# 270189

    Kasuga-shi, Fukuoka 816-0813
    Japan

    Active - Recruiting

  • Hospital of the University of Occupational and Environmental Health, Japan /ID# 269206

    Kitakyushu-shi, Fukuoka 807-8556
    Japan

    Active - Recruiting

  • Gunma University Hospital /ID# 272319

    Maebashi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Sapporo Shiroishi Dermatology Clinic /ID# 269691

    Sapporo-shi, Hokkaido 003-0026
    Japan

    Active - Recruiting

  • Hirase Allergie Children's Clinic /ID# 271208

    Kobe, Hyogo 653-0836
    Japan

    Active - Recruiting

  • Ryuseidai Children's Clinic /ID# 271400

    Tsukuba, Ibaraki 305-0008
    Japan

    Active - Recruiting

  • University of Tsukuba Hospital /ID# 271238

    Tsukuba-shi, Ibaraki 305-8576
    Japan

    Active - Recruiting

  • Takeoka Dermatology Clinic /ID# 269199

    Marugame, Kagawa 763-0074
    Japan

    Active - Recruiting

  • Musashikosugi Sasamoto Pediatric and Allergy Clinic /ID# 270381

    Kawasaki-shi, Kanagawa 211-0004
    Japan

    Active - Recruiting

  • National Hospital Organization Sagamihara National Hospital /ID# 271575

    Sagamihara, Kanagawa 252-0315
    Japan

    Active - Recruiting

  • Aoi Dermatology Clinic /ID# 274265

    Kamimashiki-gun, Kumamoto 861-2236
    Japan

    Active - Recruiting

  • Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198

    Neyagawa-shi, Osaka 572-0838
    Japan

    Active - Recruiting

  • Hayami Dermatology Clinic /ID# 269945

    Osaka-shi, Osaka 537-0013
    Japan

    Active - Recruiting

  • Medical corporation Jun Dermatology Clinic /ID# 269953

    Osaka-shi, Osaka 558-0003
    Japan

    Active - Recruiting

  • Momodani Skin Clinic /ID# 270384

    Osaka-shi, Osaka 543-0033
    Japan

    Active - Recruiting

  • Dermatology and Ophthalmology Kume Clinic /ID# 271854

    Sakai City, Osaka 5938324
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 270367

    Mibu, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Fukuwa clinic /ID# 269203

    Chuo-ku, Tokyo 104-0031
    Japan

    Active - Recruiting

  • Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194

    Setagaya-ku, Tokyo 157-0066
    Japan

    Active - Recruiting

  • Saitama City Hospital /ID# 271392

    Saitama, 336-8522
    Japan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.