This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis

A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up)

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000434-42-BE

Enrollment

454

Registered

2022-07-25

Start date

2023-05-09

Completion date

Unknown

Last updated

2025-02-24

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: • Male or female subjects =18 and =65 years) no F.1.3.1 Number of subjects for this age range

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 treatment • Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30 mg QD in subjects who do not achieve Eczema Area and Severity Index (EASI) 90 on upadacitinib 15 mg QD after 12 weeks. 2. Sub-Study 2 (SS2): The primary study objective for SS2 is to evaluate the efficacy and safety of dose reduction to upadacitinib 15 mg QD in subjects who achieve EASI 90 on upadacitinib 30 mg QD after 12 weeks. No hypothesis testing will be performed in this study.;Secondary Objective: N/A;Primary end point(s): The primary endpoints is: Achievement of EASI 90 at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30 mg QD in subjects who do not achieve Eczema Area and Severity Index (EASI) 90 on upadacitinib 15 mg QD after 12 weeks. 2. Sub-Study 2 (SS2): The primary study objective for SS2 is to evaluate the efficacy and safety of dose reduction to upadacitinib 15 mg QD in subjects who achieve EASI 90 on upadacitinib 30 mg QD after 12 weeks. No hypothesis testing will be performed in this study.;Secondary Objective: N/A;Primary end point(s): The primary endpoints is: Achievement of EASI 90 at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: 1. Achievement of EASI 75 / 100 at Week 24. 2. Achievement of EASI 75 / 90 / 100 at Week 12. 3. Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24. 4. Achievement of a vIGA-AD of 0 or 1 at Week 12. 5. Achievement of vIGA-AD of 0 or 1 at Week 24. 6. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 for subjects with Worst Pruritus NRS = 4 at Baseline at Week 12. 7. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 for subjects with Worst Pruritus NRS = 4 at Baseline at Week 24. 8. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12. 9. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24. 10. Achievement of an improvement (reduction) from Baseline in DLQI = 4 for subjects with DLQI = 4 at Baseline at Week 12. 11. Achievement of an improvement (reduction) from Baseline in DLQI = 4 for subjects with DLQI = 4 at Baseline at Week 24. 12. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 12. 13. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 24.;Timepoint(s) of evaluation of this end point: Week 12/24	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: 1. Achievement of EASI 75 / 100 at Week 24. 2. Achievement of EASI 75 / 90 / 100 at Week 12. 3. Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24. 4. Achievement of a vIGA-AD of 0 or 1 at Week 12. 5. Achievement of vIGA-AD of 0 or 1 at Week 24. 6. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 for subjects with Worst Pruritus NRS = 4 at Baseline at Week 12. 7. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 for subjects with Worst Pruritus NRS = 4 at Baseline at Week 24. 8. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12. 9. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24. 10. Achievement of an improvement (reduction) from Baseline in DLQI = 4 for subjects with DLQI = 4 at Baseline at Week 12. 11. Achievement of an improvement (reduction) from Baseline in DLQI = 4 for subjects with DLQI = 4 at Baseline at Week 24. 12. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 12. 13. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 24.;Timepoint(s) of evaluation of this end point: Week 12/24

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Countries

Australia, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Slovakia, Spain, Taiwan, United Kingdom

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