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

[M23-696]A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011230002

Enrollment

880

Registered

2023-04-10

Start date

2023-07-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

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: Participant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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]	—

Measure

Time frame

- 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]

—

Countries

Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactContact for Patients and HCP

AbbVie. G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026