This is a study to compare the safety and efficacy of Upadacitinib to Dupilumab in subjects with Moderate to Severe Atopic Dermatitis

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002482-15-SE

Enrollment

880

Registered

2022-11-09

Start date

2022-12-12

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

Moderate to 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: Tablet INN or Proposed INN: Upadacitinib Current Sponsor code: ABT-494 Concentration unit: mg milligram(s) Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o Subjects must be at least = 12 years old and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: o Prior exposure to any oral or topical JAK inhibitor (including but not limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], ruxolitinib [Jakafi® or Opzelura®], baricitinib [Olumiant®], peficitinib [Smyraf®], abrocitinib [Cibinqo®], and filgotinib [Jyseleca®]), fedratinib [Inrebic®], and deucravacitinib [Sotyktu™]). o Prior exposure to dupilumab, tralokinumab, or lebrikizumab

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary study objective, related to Study Period 1, is to assess the efficacy and safety of upadacitinib, initiated at 15 mg once daily (QD) and dose adjusted based on clinical response, compared with dupilumab as per its label. An additional objective, related to Study Period 2, is to assess the efficacy and safety of upadacitinib, initiated at 15 mg QD, in subjects with inadequate response to dupilumab. The primary efficacy objective is based on the achievement of a composite endpoint of at least a 90% reduction in EASI from baseline (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 with the treatment of upadacitinib compared with dupilumab per its label in the Intent-to-Treat (ITT) Population, which consists of all randomized subjects.;Secondary Objective: Ranked Secondary Endpoints: 1. Achievement of EASI 90 at Week 16. 2. Achievement of WP-NRS 0/1 at Week 16 among subjects with Baseline Worst Pruritus NRS > 1. 3. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 at Week 16 among subjects with Baseline Worst Pruritus NRS = 4. 4. Achievement of WP-NRS 0/1 at Week 4 among subjects with Baseline Worst Pruritus NRS > 1. 5. Achievement of WP-NRS 0/1 at Week 2 among subjects with Baseline Worst Pruritus NRS > 1. 6. Achievement of EASI 90 at Week 4. 7. Achievement of EASI 75 at Week 2. 8. Achievement of EASI 100 at Week 16;Primary end point(s): The primary endpoint is the achievement of a composite endpoint of both EASI 90 and WP-NRS 0/1 at Week 16.;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Main Objective: The primary study objective, related to Study Period 1, is to assess the efficacy and safety of upadacitinib, initiated at 15 mg once daily (QD) and dose adjusted based on clinical response, compared with dupilumab as per its label. An additional objective, related to Study Period 2, is to assess the efficacy and safety of upadacitinib, initiated at 15 mg QD, in subjects with inadequate response to dupilumab. The primary efficacy objective is based on the achievement of a composite endpoint of at least a 90% reduction in EASI from baseline (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 with the treatment of upadacitinib compared with dupilumab per its label in the Intent-to-Treat (ITT) Population, which consists of all randomized subjects.;Secondary Objective: Ranked Secondary Endpoints: 1. Achievement of EASI 90 at Week 16. 2. Achievement of WP-NRS 0/1 at Week 16 among subjects with Baseline Worst Pruritus NRS > 1. 3. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 at Week 16 among subjects with Baseline Worst Pruritus NRS = 4. 4. Achievement of WP-NRS 0/1 at Week 4 among subjects with Baseline Worst Pruritus NRS > 1. 5. Achievement of WP-NRS 0/1 at Week 2 among subjects with Baseline Worst Pruritus NRS > 1. 6. Achievement of EASI 90 at Week 4. 7. Achievement of EASI 75 at Week 2. 8. Achievement of EASI 100 at Week 16;Primary end point(s): The primary endpoint is the achievement of a composite endpoint of both EASI 90 and WP-NRS 0/1 at Week 16.;Timepoint(s) of evaluation of this end point: Week 16

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Secondary

Measure	Time frame
Secondary end point(s): The ranked secondary endpoints are: 1. Achievement of EASI 90 at Week 16 2. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Baseline Worst Pruritus NRS > 1, at Week 16 3. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 for subjects with Baseline Worst Pruritus NRS = 4, at Week 16 4. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Baseline Worst Pruritus NRS > 1, at Week 4 5. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Baseline Worst Pruritus NRS > 1, at Week 2 6. Achievement of EASI 90 at Week 4 7. Achievement of EASI 75 at Week 2 8. Achievement of EASI 100 at Week 16 ;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Secondary end point(s): The ranked secondary endpoints are: 1. Achievement of EASI 90 at Week 16 2. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Baseline Worst Pruritus NRS > 1, at Week 16 3. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 for subjects with Baseline Worst Pruritus NRS = 4, at Week 16 4. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Baseline Worst Pruritus NRS > 1, at Week 4 5. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Baseline Worst Pruritus NRS > 1, at Week 2 6. Achievement of EASI 90 at Week 4 7. Achievement of EASI 75 at Week 2 8. Achievement of EASI 100 at Week 16 ;Timepoint(s) of evaluation of this end point: Week 16

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Countries

Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactGlobal 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