Status:
WITHDRAWN
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
Lead Sponsor:
AbbVie
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
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 upada...
Eligibility Criteria
Inclusion
- Body weight \>= 40 kg at the Baseline Visit for participants between \>= 12 and \< 18 years of age.
- Chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
- Eczema Area and Severity Index (EASI) score \>= 16 at the Screening and Baseline Visits.
- Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3 at the Screening and Baseline Visits.
- \>= 10% body surface area of AD involvement at the Screening and Baseline Visits.
- Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 at Screening and Baseline Visits.
- Documented history (within 1 year prior to the Screening Visit) of inadequate response (IR) to systemic methotrexate (MTX) and/or cyclosporin A (CsA) or not a candidate for systemic treatment with MTX or CsA as a result of intolerance or medical contraindication.
Exclusion
- Prior exposure to any systemic Janus kinase (JAK) inhibitor.
- Prior exposure to dupilumab.
- Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit:
- Corticosteroids, MTX, CsA, azathioprine. phosphodiesterase type 4 (PDE4)-inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks.
- Targeted biologic treatments (refer to within 5 half-lives \[if known\]) or within 12 weeks, whichever is longer.
- Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
- Oral or parenteral traditional medicine within 4 weeks.
- Moisturizers that contain Topical corticosteroids (TCS), Topical calcineurin inhibitor (TCI)s, or topical Phosphodiesterase type 4 (PDE-4) inhibitors within 7 days.
Key Trial Info
Start Date :
December 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04666675
Start Date
December 24 2020
End Date
March 23 2021
Last Update
April 8 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.