[M25-145] A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the 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

JRCT ID: jRCT2061240088

Registered date:10/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 10/12/2024
• Target sample size: 98
• Study type: Interventional

Intervention(s)

Placebo Comparator: Placebo / Upadacitinib + Topical Corticosteroids (TCS)
Participants will receive placebo orally once a day (QD) in combination with TCS for 12 weeks in the double-blind treatment period. At Week 12 participants will then be switched to receive open-label upadacitinib daily adult equivalent dose in combination with TCS.

Experimental: Upadacitinib + Topical Corticosteroids (TCS)
Participants will be randomized to receive the upadacitinib daily adult equivalent dose in combination with TCS once a day (QD) during the double-blind and open label treatment periods for a total of 52 weeks.

Outcome(s)

Primary Outcome

- Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75 at Week 12
- Number of Participants With Adverse Events

Secondary Outcome

- Percentage of participants achieving validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) 0/1 with a reduction from Baseline of 2 points at Week 12
- Percentage of participants achieving an improved (reduced) weekly average Worst Itch Scale (WIS) score of 4 from Baseline at Week 12 for participants equal or greater than 6 years old with a weekly average WIS of 4 at Baseline
- Percentage of participants achieving an improved (reduced) weekly average Worst Scratch/Itch numerical rating scale (WIS-NRS) score of 4 from Baseline at Week 12 for participants less than 6 years old with a weekly average WIS of 4 at Baseline

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: < 12age old
• Gender: Both

Include 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).

Exclude 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.

Related Information

• Primary Sponsor: Fujimura Kimino
• Secondary ID(s): NCT06701331