A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil

Sponsor
AbbVie
Study ID
NCT04666675
Phase
PHASE3
Status
Withdrawn

Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

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

Interventions

Study Details

Atopic Dermatitis (AD) is a chronic inflammatory skin disease that is characterized by intense itching, oozing and crusting, redness, skin erosion and dry skin. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat participants with moderate to severe AD in Brazil. The study will assess change in disease signs and symptoms. Upadacitinib is an investigational drug being developed for the treatment of Atopic Dermatitis (AD). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Participants with a diagnosis of AD will be enrolled. Around 150 participants will be enrolled in the study in approximately 20 sites in Brazil. Participants will receive the following for up to 52 weeks: Participants will receive oral upadacitinib tablets once daily for up to week 52. Participants may also receive oral placebo tablets once daily up to week 16 followed by oral upadacitinib tablets once daily up to week 52. Arm 1: Upadacitinib Dose A up to week 52. Arm 2: Upadacitinib Dose B up to week 52. Arm 3: Placebo up to week 16 followed by upadacitinib Dose A up to week 52. Arm 4: Placebo up to week 16 followed by upadacitinib Dose B up to week 52. There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Key Dates

Start date
Dec 24, 2020
Status verified
Apr 2021
Primary completion
Mar 23, 2021
Completion
Mar 23, 2021

Study Design

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

Arms

  • Experimental: Upadacitinib Dose A
    Participants will receive Upadacitinib Dose A once daily (QD).
  • Experimental: Upadacitinib Dose B
    Participants will receive Upadacitinib Dose B QD.
  • Experimental: Placebo for Upadacitinib Followed by Upadacitinib Dose A
    Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD.
  • Experimental: Placebo for Upadacitinib Followed by Upadacitinib Dose B
    Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD.

Primary Outcome Measure

Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline [ Time Frame: Baseline to Week 16 ]

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