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A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Level Up)

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ClinicalTrials.gov Identifier: NCT05601882
Recruitment Status : Recruiting
First Posted : November 1, 2022
Last Update Posted : March 27, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Upadacitinib Drug: Dupilumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 28, 2022
Estimated Primary Completion Date : May 7, 2025
Estimated Study Completion Date : September 25, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arms and Interventions
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Arm Intervention/treatment
Experimental: Upadacitinib
Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.
 Drug: Upadacitinib
Oral Tablets
Other Name: RINVOQ
Experimental: Dupilumab followed by Upadacitinib
Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.
 Drug: Upadacitinib
Oral Tablets
Other Name: RINVOQ

Drug: Dupilumab
Subcutaneous Injection


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1) [ Time Frame: At week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72. The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90) [ Time Frame: Up to week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.

  2. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1 [ Time Frame: Up to week 16 ]
    The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.

  3. Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 among those with Baseline WP-NRS ≥ 4 [ Time Frame: At week 16 ]
    The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.

  4. Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75) [ Time Frame: At week 2 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.

  5. Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100) [ Time Frame: At week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
  • Eczema area and severity index (EASI) score ≥ 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
  • Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4.
  • Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

Exclusion Criteria:

  • History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
  • History of an organ transplant which requires continued immunosuppression.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05601882


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05601882    
Other Study ID Numbers: M23-696
2022-002482-15 ( EudraCT Number )
First Posted: November 1, 2022    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Atopic Dermatitis
AD
Level-Up
 Upadacitinib
Dupilumab
RINVOQ
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents