Phase
Condition
Allergy
Atopic Dermatitis
Skin Infections/disorders
Treatment
Upadacitinib
Placebo
Clinical Study ID
Ages 2-11 All Genders
Study Summary
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
Connect with a study center
Central Clinic /ID# 269205
Nagoya-shi, Aichi 464-0821
JapanActive - Recruiting
Fujita Health University Hospital /ID# 269201
Toyoake, Aichi 470-1192
JapanActive - Recruiting
Miyata Dermatology Clinic /ID# 269200
Matsudo-Shi, Chiba 271-0092
JapanActive - Recruiting
Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192
Fukuoka-shi, Fukuoka 814-0171
JapanActive - Recruiting
Saruta Dermatology Clinic /ID# 270416
Fukuoka-shi, Fukuoka 819-0043
JapanActive - Recruiting
Tokunaga Skin Clinic /ID# 270189
Kasuga-shi, Fukuoka 816-0813
JapanActive - Recruiting
Hospital of the University of Occupational and Environmental Health, Japan /ID# 269206
Kitakyushu-shi, Fukuoka 807-8556
JapanActive - Recruiting
Gunma University Hospital /ID# 272319
Maebashi, Gunma 371-8511
JapanActive - Recruiting
Sapporo Shiroishi Dermatology Clinic /ID# 269691
Sapporo-shi, Hokkaido 003-0026
JapanActive - Recruiting
Hirase Allergie Children's Clinic /ID# 271208
Kobe, Hyogo 653-0836
JapanActive - Recruiting
Ryuseidai Children's Clinic /ID# 271400
Tsukuba, Ibaraki 305-0008
JapanActive - Recruiting
University of Tsukuba Hospital /ID# 271238
Tsukuba-shi, Ibaraki 305-8576
JapanActive - Recruiting
Takeoka Dermatology Clinic /ID# 269199
Marugame, Kagawa 763-0074
JapanActive - Recruiting
Musashikosugi Sasamoto Pediatric and Allergy Clinic /ID# 270381
Kawasaki-shi, Kanagawa 211-0004
JapanActive - Recruiting
National Hospital Organization Sagamihara National Hospital /ID# 271575
Sagamihara, Kanagawa 252-0315
JapanActive - Recruiting
Aoi Dermatology Clinic /ID# 274265
Kamimashiki-gun, Kumamoto 861-2236
JapanActive - Recruiting
Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198
Neyagawa-shi, Osaka 572-0838
JapanActive - Recruiting
Hayami Dermatology Clinic /ID# 269945
Osaka-shi, Osaka 537-0013
JapanActive - Recruiting
Medical corporation Jun Dermatology Clinic /ID# 269953
Osaka-shi, Osaka 558-0003
JapanActive - Recruiting
Momodani Skin Clinic /ID# 270384
Osaka-shi, Osaka 543-0033
JapanActive - Recruiting
Dermatology and Ophthalmology Kume Clinic /ID# 271854
Sakai City, Osaka 5938324
JapanActive - Recruiting
Dokkyo Medical University Hospital /ID# 270367
Mibu, Tochigi 321-0293
JapanActive - Recruiting
Fukuwa clinic /ID# 269203
Chuo-ku, Tokyo 104-0031
JapanActive - Recruiting
Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194
Setagaya-ku, Tokyo 157-0066
JapanActive - Recruiting
Saitama City Hospital /ID# 271392
Saitama, 336-8522
JapanActive - Recruiting
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