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
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
2 other identifiers
interventional
272
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2018
Typical duration for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedStudy Start
First participant enrolled
October 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2022
CompletedMarch 1, 2023
February 1, 2023
3.8 years
September 5, 2018
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants experiencing adverse events
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
Study Arms (4)
Arm A
EXPERIMENTALUpadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
Arm B
EXPERIMENTALUpadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
Arm C
EXPERIMENTALPlacebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
Arm D
EXPERIMENTALPlacebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
Interventions
It is administered concomitantly with upadacitinib or placebo.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (43)
Ichinomiya Municipal Hospital /ID# 205942
Ichinomiya-shi, Aichi-ken, 491-8558, Japan
Central Clinic /ID# 206558
Nagoya, Aichi-ken, 464-0821, Japan
Nagoya City University Hospital /ID# 207566
Nagoya, Aichi-ken, 467-8602, Japan
Yasumoto Dermatology Clinic /ID# 206480
Chikushino-shi, Fukuoka, 818-0083, Japan
Kiryu Dermatology Clinic /ID# 206044
Fukuoka, Fukuoka, 813-0044, Japan
Medical Corporation Matsuo Clinic /ID# 207323
Fukuoka, Fukuoka, 819-0373, Japan
Matsuda Tomoko Dermatological Clinic /ID# 206288
Fukuoka, Fukuoka, 8190167, Japan
Higuchi Dermatology Urology Clinic /ID# 206287
Kasuga-shi, Fukuoka, 816-0802, Japan
Central Japan International Medical Center /ID# 205684
Minokamo-shi, Gifu, 505-8510, Japan
Kiryu Kosei General Hospital /ID# 206155
Kiryu-shi, Gunma, 376-0024, Japan
Gunma University Hospital /ID# 207016
Maebashi, Gunma, 371-8511, Japan
Fukuyama City Hospital /ID# 206761
Fukuyama-shi, Hiroshima, 721-8511, Japan
Asahikawa Medical University Hospital /ID# 206521
Asahikawa-shi, Hokkaido, 078-8510, Japan
Medical Corporation Kato Dermatology Clinic /ID# 206561
Sapporo, Hokkaido, 003-0026, Japan
Kitago Dermatology Clinic /ID# 207025
Sapporo, Hokkaido, 003-0833, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519
Sapporo, Hokkaido, 060-0033, Japan
Kansai Rosai Hospital /ID# 205918
Amagasaki-shi, Hyōgo, 660-8511, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 206974
Amagasaki-shi, Hyōgo, 660-8550, Japan
Kobe University Hospital /ID# 206200
Kobe, Hyōgo, 650-0017, Japan
Tokai University Hospital /ID# 206657
Isehara-shi, Kanagawa, 259-1193, Japan
Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766
Kawasaki-shi, Kanagawa, 211-0063, Japan
Nippon Medical School Musashi Kosugi Hospital /ID# 206656
Kawasaki-shi, Kanagawa, 211-8533, Japan
Yokohama Rosai Hospital /ID# 206648
Yokohama, Kanagawa, 222-0036, Japan
Suizenji Dermatology Clinic /ID# 205871
Kumamoto, Kumamoto, 862-0950, Japan
Nagasaki University Hospital /ID# 206118
Nagasaki, Nagasaki, 852-8501, Japan
Nagaoka Red Cross Hospital /ID# 209817
Nagaoka-shi, Niigata, 940-2085, Japan
Isonokami dermatological clinic /ID# 206923
Daito-shi, Osaka, 574-0046, Japan
Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704
Neyagawa, Osaka, 572-0838, Japan
Shizuoka General Hospital /ID# 207122
Shizuoka, Shizuoka, 420-8527, Japan
Mildix Skin Clinic /ID# 206829
Adachi-ku, Tokyo, 120-0034, Japan
Yaesu Nihonbashi Skin Clinic /ID# 207125
Chuo-ku, Tokyo, 103-0028, Japan
Fukuwa clinic /ID# 206760
Chuo-ku, Tokyo, 103-0031, Japan
Hosono Clinic /ID# 205953
Chuo-ku, Tokyo, 104-0031, Japan
Nihon University Itabashi Hospital /ID# 206186
Itabashi-ku, Tokyo, 173-8610, Japan
Mita Dermatology /ID# 206694
Minato-ku, Tokyo, 108-0014, Japan
Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882
Nakano-ku, Tokyo, 164-0001, Japan
Matsuyama Dermatology /ID# 205998
Nakano-ku, Tokyo, 165-0026, Japan
Miu Skin Clinic /ID# 206911
Ōta-ku, Tokyo, 114-0052, Japan
Tokyo Rosai Hospital /ID# 205809
Ōta-ku, Tokyo, 143-0013, Japan
Tampopo Dermatology Clinic /ID# 207013
Ōta-ku, Tokyo, 1430023, Japan
Naoko Dermatology Clinic /ID# 205334
Setagaya-ku, Tokyo, 158-0097, Japan
Tachikawa Dermatology Clinic /ID# 206996
Tachikawa-shi, Tokyo, 1900023, Japan
Toyama Prefectural Central Hospital /ID# 206286
Toyama, Toyama, 930-8550, Japan
Related Publications (4)
Katoh N, Ikeda M, Ohya Y, Murota H, Hu X, Liu J, Niiyama H, Sasaki T, Raymundo EM, Saeki H. Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: Analysis of the 3-Year Phase 3 Rising Up Study. Dermatol Ther (Heidelb). 2024 Jan;14(1):213-232. doi: 10.1007/s13555-023-01071-2. Epub 2023 Dec 21.
PMID: 38127188DERIVEDHayashi N, Ikeda M, Liu J, Raymundo E, Liu Y, Sasaki T, Yamasaki K. Acne Among Japanese Patients with Atopic Dermatitis Receiving Upadacitinib in the Phase 3 Rising Up Study. Dermatol Ther (Heidelb). 2023 Aug;13(8):1817-1830. doi: 10.1007/s13555-023-00961-9. Epub 2023 Jun 25.
PMID: 37356075DERIVEDKatoh N, Ohya Y, Murota H, Ikeda M, Hu X, Ikeda K, Liu J, Sasaki T, Raymundo EM, Teixeira HD, Saeki H. Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study. Dermatol Ther (Heidelb). 2023 Jan;13(1):221-234. doi: 10.1007/s13555-022-00842-7. Epub 2022 Nov 19.
PMID: 36401761DERIVEDTanaka T, Sasaki T, Ikeda K, Liu J, Tenorio AR, Ohya Y. Growth analysis among adolescents with moderate-to-severe atopic dermatitis receiving upadacitinib in combination with topical corticosteroids in Japan: A case study series from a phase 3, randomized, controlled trial (Rising Up). World Allergy Organ J. 2022 Sep 13;15(9):100678. doi: 10.1016/j.waojou.2022.100678. eCollection 2022 Sep.
PMID: 36185549DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 7, 2018
Study Start
October 27, 2018
Primary Completion
August 19, 2022
Study Completion
August 19, 2022
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.