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)

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) - M23-696

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53823

Enrollment

Registered

2022-12-15

Start date

2023-08-15

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Atopic dermatitis eczema

Interventions

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

Eligibility

Age

12 Years to 64 Years

Inclusion criteria

Inclusion criteria: o Subjects must be at least >= 12 years old and = 12 and = 40 kg at the Baseline Visit for subjects between >= 12 and = 16; vIGA-AD score >= 3 and >= 10% BSA of AD involvement at the Baseline Visit; o Baseline weekly average of daily Worst Pruritus NRS >= 4. o 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 (e.g., because of important side effects or safety risks).

Exclusion criteria

Exclusion criteria: o Prior exposure to any oral or topical JAK inhibitor (including but not limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], ruxolitinib [Jakafi® or Opzelura®], baricitinib [Olumiant®], peficitinib [Smyraf®], abrocitinib [Cibinqo®], and filgotinib [Jyseleca®]), fedratinib [Inrebic®], and deucravacitinib [Sotyktu*]) o Prior exposure to dupilumab, tralokinumab, or lebrikizumab

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) 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 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 up to week 16 - Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75) at week 2 - Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100) at week 16 - Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90) up tp 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 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 up to week 16 - Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75) at week 2 - Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100) at week 16 - Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90) up tp week 16

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)