A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Sponsor
AbbVie
Study ID
NCT03661138
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Upadacitinib is administered orally.
  • Placebo for upadacitinib — DRUG
    Placebo is administered orally.
  • Topical Corticosteroids (TCS) — DRUG
    It is administered concomitantly with upadacitinib or placebo.

Study Details

The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Key Dates

Start date
Oct 27, 2018
Status verified
Feb 2023
Primary completion
Aug 19, 2022
Completion
Aug 19, 2022

Study Design

Enrollment
272 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
  • Experimental: Arm B
    Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
  • Experimental: Arm C
    Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
  • Experimental: Arm D
    Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.

Primary Outcome Measure

Number of participants experiencing adverse events [ Time Frame: Up to 141 Weeks ]

Related Studies