A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (Measure Up 2)

• ClinicalTrials.gov Identifier: NCT03607422
• Recruitment Status: Active, not recruiting
• First Posted: July 31, 2018
• Last Update Posted: December 8, 2020
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: July 25, 2018
• First Posted Date: July 31, 2018
• Last Update Posted Date: December 8, 2020
• Actual Study Start Date: July 27, 2018
• Estimated Primary Completion Date: March 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 20, 2020)

• Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index (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).
• Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at Least Two Grades of Reduction from Baseline [ 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 (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.

Current Secondary Outcome Measures (submitted: May 20, 2020)

• Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline for Participants with Worst Pruritus NRS ≥ 4 at 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.
• Percentage 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.
• Percentage of Participants Achieving 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.
• Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 for Participants with Worst Pruritus NRS ≥ 4 at Baseline and 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.
• Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 for Participants with Worst Pruritus NRS ≥ 4 at Baseline and 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.
• Percentage of Participants Experiencing a Flare [ Time Frame: Up to Week 16 ]
  Defined as clinically meaningful worsening in EASI.
• Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score ≥ 12 (Minimal Clinically Important Difference (MCID)) from Baseline [ Time Frame: At Week 16 ]
  This is assessed for participants with ADerm-IS sleep domain score ≥ 12 (MCID) at baseline.
• Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score ≥ 4 (MCID) from Baseline [ Time Frame: At Week 16 ]
  This is assessed for participants with ADerm-SS skin pain score ≥ 4 (MCID) at baseline.
• Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) 7-item Total Symptom Score (TSS-7) ≥ 28 (MCID) from Baseline [ Time Frame: At Week 16 ]
  This is assessed for participants with ADerm-SS TSS-7 total score ≥ 28 (MCID) at baseline.
• Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Emotional State Domain score ≥ 11 (MCID) from Baseline [ Time Frame: At Week 16 ]
  This is assessed for participants with ADerm-IS emotional state domain score ≥ 11 (MCID) at baseline.
• Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Daily Activities Score ≥ 14 (MCID) from Baseline [ Time Frame: At Week 16 ]
  This is assessed for participants with ADerm-IS daily activity score ≥ 14 (MCID) at baseline.
• Percentage 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.

Original Secondary Outcome Measures (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: A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (Measure Up 2)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• Drug: Upadacitinib
  Oral; Tablet
  Other Names:

  • ABT-494
  • Rinvoq
• Drug: Placebo for Upadacitinib
  Oral; Tablet

Study Arms

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 4, 2020): 918
• Original Estimated Enrollment (submitted: July 25, 2018): 810
• Estimated Study Completion Date: July 20, 2023
• Estimated Primary Completion Date: March 2, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years of age
• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline
• Active moderate to severe AD 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 AD
• Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks

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

• Sexes Eligible for Study: All

• Ages: 12 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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

Administrative Information

• NCT Number: NCT03607422
• Other Study ID Numbers: 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

• 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: AbbVie
• Collaborators: Not Provided

Investigators

• Study Director: AbbVie Inc.; AbbVie

• PRS Account: AbbVie
• Verification Date: December 2020