Evaluation of Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Patients with Moderate to Severe Atopic Dermatitis (Eczema) – AD Up

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005126-37-GR

Enrollment

890

Registered

2018-11-01

Start date

2018-10-31

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate and Severe Atopic Dermatitis MedDRA version: 20.0 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female subjects 12-75 years of age • Active moderate to severe atopic dermatitis defined by EASI, IGA, BSA, and pruritus • Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis • Able to tolerate topical corticosteroids for atopic dermatitis lesions Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 610 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: • Prior exposure to any JAK inhibitor • Unable or unwilling to discontinue current AD treatments prior to the study • Requirement of prohibited medications during the study • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions • Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.;Secondary Objective: None;Primary end point(s): • Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16; • Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16. ;Timepoint(s) of evaluation of this end point: Week 16 Week 16	—

Measure

Time frame

Main Objective: To assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.;Secondary Objective: None;Primary end point(s): • Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16; • Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16. ;Timepoint(s) of evaluation of this end point: Week 16 Week 16

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Secondary

Measure	Time frame
Secondary end point(s): The following key secondary endpoints will be analyzed to demonstrate superiority of each upadacitinib dose vs. placebo, unless otherwise specified. Key secondary endpoints for EU/EMA regulatory purposes are: • Proportion of subjects achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 from Baseline at Week 16 for subjects with Worst Pruritus NRS = 4 at Baseline; • Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16; • Percent change from Baseline of Worst Pruritus NRS at Week 16; • Percent change in EASI score from Baseline at Week 16. • Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS = 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS = 4 at Baseline; • Proportion of subjects achieving EASI 75 at Week 4; • Proportion of subjects achieving EASI 75 at Week 2; • Proportion of subjects achieving EASI 90 at Week 4; • Proportion of subjects achieving EASI 100 at Week 16 for 30 mg; • Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS = 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS = 4 at Baseline.;Timepoint(s) of evaluation of this end point: Week 16 Week 16 Week 16 Week 16 Week 4 Week 4 Week 2 Week 4 Week 16 Week 1	—

Measure

Time frame

Secondary end point(s): The following key secondary endpoints will be analyzed to demonstrate superiority of each upadacitinib dose vs. placebo, unless otherwise specified. Key secondary endpoints for EU/EMA regulatory purposes are: • Proportion of subjects achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 from Baseline at Week 16 for subjects with Worst Pruritus NRS = 4 at Baseline; • Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16; • Percent change from Baseline of Worst Pruritus NRS at Week 16; • Percent change in EASI score from Baseline at Week 16. • Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS = 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS = 4 at Baseline; • Proportion of subjects achieving EASI 75 at Week 4; • Proportion of subjects achieving EASI 75 at Week 2; • Proportion of subjects achieving EASI 90 at Week 4; • Proportion of subjects achieving EASI 100 at Week 16 for 30 mg; • Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS = 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS = 4 at Baseline.;Timepoint(s) of evaluation of this end point: Week 16 Week 16 Week 16 Week 16 Week 4 Week 4 Week 2 Week 4 Week 16 Week 1

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Countries

Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Puerto Rico, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

global-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026