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Clinical trial

A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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Last updated:27th Jul 2018
Identifier: NCT03607422

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe AD who are candidates for systemic therapy.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date: July 27, 2018
Estimated Primary Completion Date: February 14, 2020
Estimated Study Completion Date: June 8, 2022

Arms:
- Experimental:
Arm A (Upadacitinib Dose A is administered once daily.)
- Experimental: Arm B (Upadacitinib Dose B is administered once daily.)
- Experimental: Arm C (Placebo administered once daily followed by Upadacitinib Dose A once daily.)
- Experimental: Arm D (Placebo administered once daily followed by Upadacitinib Dose B once daily.)

Category Value
Date last updated at source 2019-03-08
Study type(s) Interventional
Expected enrolment 810
Study start date 2018-07-27
Estimated primary completion date 2020-02-14

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