A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Rising Up)

• ClinicalTrials.gov Identifier: NCT03661138
• Recruitment Status: Active, not recruiting
• First Posted: September 7, 2018
• Last Update Posted: December 7, 2021
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: September 5, 2018
• First Posted Date: September 7, 2018
• Last Update Posted Date: December 7, 2021
• Actual Study Start Date: October 27, 2018
• Estimated Primary Completion Date: August 12, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 5, 2018)

Number of participants experiencing adverse events [ Time Frame: Up to 141 Weeks ]

Adverse events are defined as those that began or worsened in severity after the first dose of study drug but within 30 days after the last dose of study drug.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
• Official Title: A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis
• Brief Summary: The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (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
  Upadacitinib is administered orally.
  Other Name: ABT-494
• Drug: Placebo for upadacitinib
  Placebo is administered orally.
• Drug: Topical Corticosteroids (TCS)
  It is administered concomitantly with upadacitinib or placebo.

Study Arms

• Experimental: Arm A
  Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
  Interventions:

  • Drug: Upadacitinib
  • Drug: Topical Corticosteroids (TCS)
• Experimental: Arm B
  Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
  Interventions:

  • Drug: Upadacitinib
  • Drug: Topical Corticosteroids (TCS)
• Experimental: Arm C
  Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
  Interventions:

  • Drug: Upadacitinib
  • Drug: Placebo for upadacitinib
  • Drug: Topical Corticosteroids (TCS)
• Experimental: Arm D
  Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
  Interventions:

  • Drug: Upadacitinib
  • Drug: Placebo for upadacitinib
  • Drug: Topical Corticosteroids (TCS)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 20, 2019): 272
• Original Estimated Enrollment (submitted: September 5, 2018): 264
• Estimated Study Completion Date: August 12, 2022
• Estimated Primary Completion Date: August 12, 2022 (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.
• Able to tolerate topical corticosteroids for atopic dermatitis lesions.

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor.
• Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study.
• Requirement of prohibited medications during the study.
• Female participant 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: Japan

Administrative Information

• NCT Number: NCT03661138
• Other Study ID Numbers: M17-377
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• 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 2021