A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo to dupilumab; Biological: Upadacitinib; Biological: Dupilumab; Drug: Placebo to upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03738397

M16-046

2018-002264-57 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Full description

The study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks.

Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).

Enrollment: 673 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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673 participants in 2 patient groups

Upadacitinib 30 mg QD

Experimental group

Description:

Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.

Treatment:

Biological: Upadacitinib

Drug: Placebo to dupilumab

Dupilumab 300 mg EOW

Experimental group

Description:

Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.

Treatment:

Biological: Dupilumab

Drug: Placebo to upadacitinib