Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date December 7, 2021
Actual Study Start Date  ICMJE October 27, 2018
Estimated Primary Completion Date August 12, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE 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  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
    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  ICMJE
  • 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

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2019)
272
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
264
Estimated Study Completion Date  ICMJE August 12, 2022
Estimated Primary Completion Date August 12, 2022   (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.
  • 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  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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661138
Other Study ID Numbers  ICMJE 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  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 December 2021

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