Clinical Trials List
2018-08-31 - 2025-06-30
Phase III
Terminated4
ICD-10L20
Atopic dermatitis
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- YIH-AN KING Division of Dermatology
The Actual Total Number of Participants Enrolled
9 Completed
Audit
CRO
Taiwan National PI
Co-Principal Investigator
- I-Hsin Shih Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- Wen-Hung Chung Division of Dermatology
- Chin-Yi Yang Division of Dermatology
The Actual Total Number of Participants Enrolled
14 Completed
Audit
None
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
- WEI-HSIN WU Division of Dermatology
- 沈宜萱 Division of Dermatology
- 卓雍哲 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Proportion of subjects achieving at least a 75% reduction in
Eczema Area and Severity Index (EASI 75) from Baseline at
Week 16;
Proportion of subjects achieving validated Investigator Global
Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at
least two grades of reduction from Baseline at Week 16.
Inclution Criteria
-Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years of age
-Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline
-Active moderate to severe AD defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
-Candidate for systemic therapy or have recently required systemic therapy for AD
-Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks
Exclusion Criteria
-Prior exposure to any Janus kinase (JAK) inhibitor
-Unable or unwilling to discontinue current AD treatments prior to the study
-Requirement of prohibited medications during the study
-Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
-Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
The Estimated Number of Participants
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Taiwan
45 participants
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Global
810 participants
