Phase 3
Completed N=673
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT03738397 ↗Enrolled (actual)
673
Serious AEs
3.1%
Results posted
Feb 2022
Primary outcomePrimary: Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16 — 62.6; 72.4 percentage of participants — p=0.007
◆ Published Evidence
Highly cited
479citations · ~96 / year
Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial.
Summary
This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Linked Publications (4)
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Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial.
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Rapid Itch Improvement and Skin Clearance with Upadacitinib Versus Placebo (Measure Up 1 and Measure Up 2) and Versus Dupilumab (Heads Up): Results from Three Phase 3 Clinical Trials in Patients with Moderate-to-Severe Atopic Dermatitis.
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More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis.
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Benefit-risk profile comparison between dupilumab and upadacitinib: a structured benefit-risk assessment of the Heads Up trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16 |
62.6; 72.4 | 0.007 sig |
| SECONDARY Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16 |
-49.58; -67.78 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 |
7.9; 28.4 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 |
40.3; 61.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4 |
-32.39; -60.41 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2 |
18.2; 44.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 1 |
-8.94; -31.96 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16 |
36.4; 56.1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.
Exclusion Criteria
- Participant has prior exposure to Janus Kinase (JAK) inhibitor.
- Participant has prior exposure to dupilumab.
- Participant is unable or unwilling to discontinue current AD treatments prior to the study.
- Participant has requirement of prohibited medications during the study.
- Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
- Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Data sourced from ClinicalTrials.gov (NCT03738397) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.