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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Tablets taken orally once a day (Or equivalent oral solution taken two times a day)
Tablets taken orally once a day (Or equivalent oral solution taken two times a day)
Central Clinic - Nagoya /ID# 269205
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital /ID# 269201
Toyoake, Aichi-ken, Japan
Miyata Dermatology Clinic /ID# 269200
Matsudo-Shi, Chiba, Japan
Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192
Fukuoka, Fukuoka, Japan
Saruta Dermatology Clinic /ID# 270416
Fukuoka, Fukuoka, Japan
Tokunaga Skin Clinic /ID# 270189
Kasuga-shi, Fukuoka, Japan
Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 269206
Kitakyushu-shi, Fukuoka, Japan
Gunma University Hospital /ID# 272319
Maebashi, Gunma, Japan
Sapporo Shiroishi Dermatology Clinic /ID# 269691
Sapporo, Hokkaido, Japan
Hirase Allergie Children's Clinic /ID# 271208
Kobe, Hyōgo, Japan
...and 15 more locations
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], An EASI 75 response is defined as a 75% reduction (improvement) from Baseline in EASI score.
Time frame: At Week 12
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 56 weeks)
Percentage of participants achieving validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) 0/1 with a reduction from Baseline of ≥ 2 points
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
Time frame: At Week 12
Percentage of participants achieving an improved (reduced) weekly average Worst Itch Scale (WIS) score of ≥ 4 from Baseline for participants equal or greater than 6 years old with a weekly average WIS of ≥ 4 at Baseline
The WIS is an assessment tool that participants use to report the intensity of their pruritus. Using an 11-point scale (0 to 10) where 0 indicates no itching and 10 indicates worst itching possible, participants are asked 2 questions: "What was the worst itch you had today?" and "What was the worst itch you had last night?" The WIS will be administered to participants ≥ 6 years of age at the time of the Baseline visit.
Time frame: At Week 12
Percentage of participants achieving an improved (reduced) weekly average Worst Scratch/Itch numerical rating scale (WIS-NRS) score of ≥ 4 from Baseline for participants less than 6 years old with a weekly average WIS of ≥ 4 at Baseline
The WSI-NRS is an assessment tool that evaluates a participants scratching and itching intensity at its worst in the past 24 hours as assessed by the participants parent/legally authorized representative. Intensity is assessed on an 11-point scale (0 to 10) where 0 indicates no scratching/itching and 10 indicates worst scratching/itching possible.
Time frame: At Week 12
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