Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

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About the study

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years of age
  2. Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
  3. Active moderate to severe AD defined by:

  1. Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
  2. Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
  3. ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
  4. Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
  5. Candidate for systemic therapy or have recently required systemic therapy for AD
  6. Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
  7. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Prior exposure to any Janus kinase (JAK) inhibitor
  2. Unable or unwilling to discontinue current atopic dermatitis treatments prior to the study
  3. Requirement of prohibited medications during the study
  4. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
  5. Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Atopic Dermatitis
Age (in years)
12 - 75
Phase
PHASE3
Participants needed
912
Est. Completion Date
Oct 9, 2025
Treatment type
INTERVENTIONAL

Sponsor
AbbVie
ClinicalTrials.gov identifier
NCT03569293
Study number
M16-045

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