Last reviewed · How we verify

NCT04666675

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

Withdrawn Phase 3 Last updated 8 April 2021
What this trial tests

Phase 3 trial testing Upadacitinib in Atopic Dermatitis (AD). Withdrawn.

Timeline
24 December 2020
Primary endpoint
23 March 2021
23 March 2021

Quick facts

Lead sponsorAbbVie
PhasePhase 3
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Start date24 December 2020
Primary completion23 March 2021
Estimated completion23 March 2021

Drugs / interventions tested

Conditions studied

Sponsor

AbbVie — full company profile →

Who can join

Adults 12 to 75, any sex, with Atopic Dermatitis (AD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Decade of JAK Inhibitors: What Have We Learned and What May Be the Future?
    Liu C, Kieltyka J, Fleischmann R, Gadina M, et al · · 2021 · cited 49× · PMID 34180156 · DOI 10.1002/art.41906

Verify or expand the search:

Other trials of Upadacitinib

Trials testing the same drug.

Other recruiting trials for Atopic Dermatitis (AD)

Currently open trials in the same condition.

Other AbbVie trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04666675.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing