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Upadacitinib Extension in Atopic Dermatitis
NCT04195698Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2020
- Primary completion
- Sep 2023
- Countries
- 22
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Drugs
- upadacitinib
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 3, open-label, single-arm trial of upadacitinib in atopic dermatitis (AD), sponsored by AbbVie Inc. Primary endpoints: Number of Participants With Treatment-Emergent Adverse Events at 399 days, Number of Participants With Treatment-Emergent Adverse Events of Special Interest at 399 days and 2 more. Started Jan 2020; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Upadacitinib
Participants receive Upadacitinib 30 mg QD.
03
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events
Number of Participants With Treatment-Emergent Adverse Events of Special Interest
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings
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