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)

February 27, 2023 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Ichinomiya-shi, Aichi, Japan, 491-8558
        • Ichinomiya Municipal Hospital /ID# 205942
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 207566
      • Nagoya-shi, Aichi, Japan, 464-0821
        • Central Clinic /ID# 206558
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-0083
        • Yasumoto Dermatology Clinic /ID# 206480
      • Fukuoka-shi, Fukuoka, Japan, 813-0044
        • Kiryu Dermatology Clinic /ID# 206044
      • Fukuoka-shi, Fukuoka, Japan, 819-0373
        • Medical Corporation Matsuo Clinic /ID# 207323
      • Fukuoka-shi, Fukuoka, Japan, 8190167
        • Matsuda Tomoko Dermatological Clinic /ID# 206288
      • Kasuga-shi, Fukuoka, Japan, 816-0802
        • Higuchi Dermatology Urology Clinic /ID# 206287
    • Gifu
      • Minokamo-shi, Gifu, Japan, 505-8510
        • Central Japan International Medical Center /ID# 205684
    • Gunma
      • Kiryu-shi, Gunma, Japan, 376-0024
        • Kiryu Kosei General Hospital /ID# 206155
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Gunma University Hospital /ID# 207016
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 721-8511
        • Fukuyama City Hospital /ID# 206761
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 206521
      • Sapporo-shi, Hokkaido, Japan, 003-0026
        • Medical Corporation Kato Dermatology Clinic /ID# 206561
      • Sapporo-shi, Hokkaido, Japan, 003-0833
        • Kitago Dermatology Clinic /ID# 207025
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 660-8511
        • Kansai Rosai Hospital /ID# 205918
      • Amagasaki-shi, Hyogo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center /ID# 206974
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital /ID# 206200
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan, 259-1193
        • Tokai University Hospital /ID# 206657
      • Kawasaki-shi, Kanagawa, Japan, 211-0063
        • Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766
      • Kawasaki-shi, Kanagawa, Japan, 211-8533
        • Nippon Medical School Musashi Kosugi Hospital /ID# 206656
      • Yokohama-shi, Kanagawa, Japan, 222-0036
        • Yokohama Rosai Hospital /ID# 206648
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 862-0950
        • Suizenji Dermatology Clinic /ID# 205871
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital /ID# 206118
    • Niigata
      • Nagaoka-shi, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital /ID# 209817
    • Osaka
      • Daito-shi, Osaka, Japan, 574-0046
        • Isonokami dermatological clinic /ID# 206923
      • Neyagawa-shi, Osaka, Japan, 572-0838
        • Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704
    • Shizuoka
      • Shizuoka-shi, Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital /ID# 207122
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 120-0034
        • Mildix Skin Clinic /ID# 206829
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Yaesu Nihonbashi Skin Clinic /ID# 207125
      • Chuo-ku, Tokyo, Japan, 103-0031
        • Fukuwa clinic /ID# 206760
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Hosono Clinic /ID# 205953
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital /ID# 206186
      • Minato-ku, Tokyo, Japan, 108-0014
        • Mita Dermatology /ID# 206694
      • Nakano-ku, Tokyo, Japan, 164-0001
        • Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882
      • Nakano-ku, Tokyo, Japan, 165-0026
        • Matsuyama Dermatology /ID# 205998
      • Ota-ku, Tokyo, Japan, 114-0052
        • Miu Skin Clinic /ID# 206911
      • Ota-ku, Tokyo, Japan, 143-0013
        • Tokyo Rosai Hospital /ID# 205809
      • Ota-ku, Tokyo, Japan, 1430023
        • Tampopo Dermatology Clinic /ID# 207013
      • Setagaya-ku, Tokyo, Japan, 158-0097
        • Naoko Dermatology Clinic /ID# 205334
      • Tachikawa-shi, Tokyo, Japan, 1900023
        • Tachikawa Dermatology Clinic /ID# 206996
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital /ID# 206286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Names:
  • ABT-494
Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Experimental: Arm B
Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Names:
  • ABT-494
Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Experimental: Arm C
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Names:
  • ABT-494
Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Drug: Placebo for upadacitinib
Placebo is administered orally.
Experimental: Arm D
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
Drug: Upadacitinib
Upadacitinib is administered orally.
Other Names:
  • ABT-494
Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Drug: Placebo for upadacitinib
Placebo is administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 141 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2018

Primary Completion (Actual)

August 19, 2022

Study Completion (Actual)

August 19, 2022

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M17-377
  • 2022-002777-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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, analyses plans, 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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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