臨床研究等提出・公開システム

[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)

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

Yamazaki Hayato

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact for

AbbVie. G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

June. 01, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Atopic Dermatitis

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.

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]

- 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]

April. 26, 2023

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

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