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Clinical Trials List

Protocol NumberM16-046
NCT Number(ClinicalTrials.gov Identfier)NCT03738397

2018-12-13 - 2020-12-09

Phase III

Terminated4

ICD-10L20.0

Besnier's prurigo

ICD-10L20.81

Atopic neurodermatitis

ICD-10L20.82

Flexural eczema

ICD-10L20.83

Infantile (acute) (chronic) eczema

ICD-10L20.84

Intrinsic (allergic) eczema

ICD-10L20.89

Other atopic dermatitis

ICD-10L20.9

Atopic dermatitis, unspecified

ICD-9691.8

Other atopic dermatitis and related conditions

A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 賴柏如 Division of Dermatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Po-Yuan Wu Division of Dermatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ying-Yi Chiang Division of Dermatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chia-Yu Chu Division of Dermatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Moderate to Severe Atopic Dermatitis

Objectives

The objective of this study is to evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Test Drug

ABT-494 (Upadacitinib)

Active Ingredient

Upadacitinib

Dosage Form

tablet

Dosage

30

Endpoints

Primary Endpoint
The primary endpoint is the proportion of subjects achieving a 75% reduction in EASI (EASI 75) from
Baseline at Week 16.

Inclution Criteria

Inclusion Criteria:

Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA) and pruritus.
Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

Exclusion Criteria

Exclusion Criteria:

Participant has prior exposure to Janus Kinase (JAK) inhibitor.
Participant has prior exposure to dupilumab.
Participant is unable or unwilling to discontinue current AD treatments prior to the study.
Participant has requirement of prohibited medications during the study.
Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    650 participants