Clinical Trials List
2020-06-01 - 2021-06-16
Phase III
Terminated6
A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS
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Sponsor
Pfizer
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 李兆甯 未分科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳貞宜 無
- DINGDAR LEE 無
- Yun-Ting Chang 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林尚宏 未分科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chih-Chieh Chan 無
- WEI-HSIN WU 無
- 卓雍哲 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dupilumab
Dosage Form
Solution for Injection
Dosage
300mg/2ml
Endpoints
(PP-NRS) from baseline at Week 2.
Response based on achieving the Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline) at Week 4.
Response based on achieving the Eczema Area and Severity Index (EASI) 75 (≥75% improvement from
baseline) at Week 16.
Inclution Criteria
18 years of age or older
Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
Exclusion Criteria
Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
Have increased risk of developing venous thromboembolism
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
Other active non-AD inflammatory skin diseases or conditions affecting skin
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
The Estimated Number of Participants
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Taiwan
24 participants
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Global
600 participants
