A Phase 3 interventional study of Upadacitinib and Placebo for Upadacitinib in Atopic Dermatitis (AD), sponsored by AbbVie. Withdrawn. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
Browse Dermatitis, Atopic studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit:
Participants will receive Upadacitinib Dose A once daily (QD).
Drug: Upadacitinib
Participants will receive Upadacitinib Dose B QD.
Drug: Upadacitinib
Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD.
Drug: Upadacitinib · Drug: Placebo for Upadacitinib
Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD.
Drug: Upadacitinib · Drug: Placebo for Upadacitinib
Oral; Tablet
Also known as: Rinvoq, ABT-494
Oral; Tablet
Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Time frame: Baseline to Week 16
Number of Participants With Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Week 52
Percentage of Participants Achieving at least a 90% Reduction in Eczema Area and Severity Index (EASI 90) from Baseline
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
Time frame: Baseline to Week 16
No study locations are listed for this record.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap
This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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