Clinical Trials List
2020-05-20 - 2023-09-11
Phase III
Suspended4
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, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046
-
Trial Applicant
AbbVie
-
Sponsor
AbbVie
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 張廖年峰 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Suspended
Co-Principal Investigator
- 洪琡茹 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Suspended
Co-Principal Investigator
- Yu-Chen Huang Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Suspended
Co-Principal Investigator
- WEI-HSIN WU Division of Dermatology
- 卓雍哲 Division of Dermatology
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Suspended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Number of Participants With Adverse Events [ Time Frame: From Baseline to 30 days following last dose of study drug (Week 52) ]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Inclution Criteria
Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.
Exclusion Criteria
Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
The Estimated Number of Participants
-
Taiwan
8 participants
-
Global
600 participants
