A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants with Moderate to Severe Atopic Dermatitis

JRCT ID: jRCT2011230002

Registered date:10/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 10/07/2023
• Target sample size: 880
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Colombia,Japan,Croatia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Puerto Rico,Japan,Romania,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Upadacitinib: Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.
Dupilumab followed by Upadacitinib: Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.

Outcome(s)

Primary Outcome

Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus
Numerical Rating Scale of 0 or 1(WPNRS 0/1) [Time Frame: At week 16]

Secondary Outcome

- Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) 4 among those with Baseline WP-NRS 4 [Time Frame: At week 16]
- Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1 [Time Frame: Up to week 16]
- Percentage of Participants Achieving 75% of Eczema Area and Severity Index(EASI 75) [Time Frame: At week 2]
- Percentage of Participants Achieving 100% of Eczema Area and Severity Index(EASI 100) [Time Frame: At week 16]
- Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90) [Time Frame: Up to week 16]

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
- Eczema area and severity index (EASI) score 16: validated Investigators Global Assessment for AD (vIGA-AD) score 3 and 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
- Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) 4.
- Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

Exclude criteria

- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- History of an organ transplant which requires continued immunosuppression.

Related Information

• Primary Sponsor: Yamazaki Hayato
• Secondary ID(s): NCT05601882