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

• ClinicalTrials.gov Identifier: NCT03607422
• Recruitment Status: Recruiting
• First Posted: July 31, 2018
• Last Update Posted: September 17, 2019
• 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: September 17, 2019
• Actual Study Start Date: July 27, 2018
• Estimated Primary Completion Date: February 14, 2020 (Final data collection date for primary outcome measure)

Current 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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03607422 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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 (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
• 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
  It is administered orally.
  Other Name: ABT-494
• Drug: Placebo for Upadacitinib
  It is administered orally.

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

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 12 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 847.283.8955; abbvieclinicaltrials@abbvie.com

• 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)
• 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: AbbVie
• Collaborators: Not Provided

Investigators

• Study Director: AbbVie Inc.; AbbVie

• PRS Account: AbbVie
• Verification Date: September 2019