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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738397
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 13, 2018
Last Update Posted Date July 6, 2021
Actual Study Start Date  ICMJE February 21, 2019
Actual Primary Completion Date August 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
Percentage of participants achieving a 75% reduction in Eczema Area and Severity Index (EASI) (EASI 75) from Baseline [ 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • Percent change in worst pruritus numerical rating scale (NRS) [ Time Frame: From Baseline (Week 0) to Week 16 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
  • Percentage of participants achieving a 100% reduction in EASI (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 AD.
  • Percentage of participants achieving a 90% reduction in EASI (EASI 90) [ 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.
  • Percent change in worst pruritus NRS [ Time Frame: From Baseline (Week 0) to Week 4 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
  • Percentage of participants achieving a 75% reduction in EASI (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 AD.
  • Percent change in worst pruritus NRS [ Time Frame: From Baseline (Week 0) to Week 1 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Percent change in worst pruritus numerical rating scale (NRS) [ Time Frame: From Baseline (Week 0) to Week 16 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
  • Percentage of participants achieving a 100% reduction in EASI (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 AD.
  • Percentage of participants achieving a 90% reduction in EASI (EASI 90) [ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
Brief Summary This is a phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The study is comprised of a 35-day screening period, a 24-week blinded treatment period, and a 12-week follow-up period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Upadacitinib (ABT-494)
    Oral; Tablet
    Other Names:
    • ABT-494
    • RINVOQ
  • Drug: Dupilumab
    Dupilumab is administered as a subcutaneous (SC) injection
  • Drug: Placebo
    Placebo pre-filled syringe is as administered subcutaneous (SC) injections
  • Drug: Placebo
    Oral; Tablet
Study Arms  ICMJE
  • Experimental: Participants administered with upadacitinib
    Participants are administered with upadacitinib from baseline to week 24 and placebo pre-filled syringe at baseline visit (2 injections) followed by an injection every other week until week 22
    Interventions:
    • Drug: Upadacitinib (ABT-494)
    • Drug: Placebo
  • Experimental: Participants administered with dupilumab
    Participants are administered with dupilumab (2 injections) at baseline followed by one every other week until week 22 and placebo tablets daily from baseline to week 24
    Interventions:
    • Drug: Dupilumab
    • Drug: Placebo
Publications * Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, De Bruin-Weller M, Barbarot S, Prajapati VH, Lio P, Hu X, Wu T, Liu J, Ladizinski B, Chu AD, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Sep 1;157(9):1047-1055. doi: 10.1001/jamadermatol.2021.3023. Erratum in: JAMA Dermatol. 2021 Dec 15;:.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2021)
692
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
650
Actual Study Completion Date  ICMJE December 9, 2020
Actual Primary Completion Date August 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA) and pruritus.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Croatia,   Czechia,   Finland,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Malaysia,   Netherlands,   New Zealand,   Norway,   Poland,   Singapore,   Spain,   Sweden,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03738397
Other Study ID Numbers  ICMJE M16-046
2018-002264-57 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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 and 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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP