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A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03607422
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE July 25, 2018
First Posted Date  ICMJE July 31, 2018
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE July 27, 2018
Estimated Primary Completion Date February 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) [ 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).
  • Proportion of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03607422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline [ Time Frame: Up 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.
  • Proportion of participants achieving 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 AD.
  • Proportion of participants achieving EASI 50 [ Time Frame: At Week 1 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
  • Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline at day 2 for participants randomized to dose A [ Time Frame: At Day 2 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
  • Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline at day 3 for participants randomized to dose B [ Time Frame: At Day 3 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
  • Proportion of participants achieving an improvement (reduction) in Atopic dermatitis impact scale (ADerm-IS) sleep domain score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-IS sleep domain score ≥ MCID.
  • Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) skin pain score ≥ MCID [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-SS skin pain score ≥ MCID.
  • Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) total score ≥ MCID [ Time Frame: Up to Week 16 ]
    This is assessed for participants with ADerm-SS total score ≥ MCID.
  • Proportion of participants achieving an improvement (reduction) in ADerm-IS total score ≥ MCID [ Time Frame: Up to Week 16 ]
    This is assessed for participants with ADerm-IS total score ≥ MCID.
  • Proportion of participants achieving 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.
  • Proportion of participants achieving vIGA-AD of 0 with a reduction of ≥ 2 points [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
  • Proportion of participants achieving EASI 75 [ Time Frame: Up to Week 4 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 [ Time Frame: At 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.
  • Proportion of participants achieving 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.
  • Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline [ Time Frame: At 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.
  • Proportion of participants achieving EASI 50 [ Time Frame: At Week 1 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
  • Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline at day 2 for participants randomized to dose A [ Time Frame: At Day 2 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
  • Proportion of participants achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline at day 3 for participants randomized to dose B [ Time Frame: At Day 3 ]
    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
  • Proportion of participants achieving an improvement (reduction) in Atopic dermatitis impact scale (ADerm-IS) sleep domain score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-IS sleep domain score ≥ MCID.
  • Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) skin pain score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-SS skin pain score ≥ MCID.
  • Proportion of participants achieving an improvement (reduction) in Atopic dermatitis symptom scale (ADerm-SS) total score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-SS total score ≥ MCID.
  • Proportion of participants achieving an improvement (reduction) in ADerm-IS total score ≥ Minimal clinically important difference (MCID) [ Time Frame: At Week 16 ]
    This is assessed for participants with ADerm-IS total score ≥ MCID.
  • Proportion of participants achieving 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.
  • Proportion of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 with a reduction of ≥ 2 points [ Time Frame: At Week 16 ]
    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Brief Summary The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe AD who are candidates for systemic therapy.
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
    It is administered orally.
    Other Name: ABT-494
  • Drug: Placebo for Upadacitinib
    It is administered orally.
Study Arms  ICMJE
  • Experimental: Arm A
    Upadacitinib Dose A is administered once daily.
    Intervention: Drug: Upadacitinib
  • Experimental: Arm B
    Upadacitinib Dose B is administered once daily.
    Intervention: Drug: Upadacitinib
  • Experimental: Arm C
    Placebo administered once daily followed by Upadacitinib Dose A once daily.
    Interventions:
    • Drug: Upadacitinib
    • Drug: Placebo for Upadacitinib
  • Experimental: Arm D
    Placebo administered once daily followed by Upadacitinib Dose B once daily.
    Interventions:
    • Drug: Upadacitinib
    • Drug: Placebo for Upadacitinib
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2018)
810
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 7, 2022
Estimated Primary Completion Date February 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
  • Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis

Exclusion Criteria:

  • Prior exposure to any Janus kinase (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE American Samoa,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Netherlands,   New Zealand,   Portugal,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03607422
Other Study ID Numbers  ICMJE M18-891
2018-001383-28 ( 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.: No
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)
Supporting Materials: Analytic Code
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 September 2019

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