A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03661138
Last Updated: 2023-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2018-10-27
2022-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
Upadacitinib
Upadacitinib is administered orally.
Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Arm B
Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
Upadacitinib
Upadacitinib is administered orally.
Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Arm C
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
Upadacitinib
Upadacitinib is administered orally.
Placebo for upadacitinib
Placebo is administered orally.
Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Arm D
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
Upadacitinib
Upadacitinib is administered orally.
Placebo for upadacitinib
Placebo is administered orally.
Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Interventions
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Upadacitinib
Upadacitinib is administered orally.
Placebo for upadacitinib
Placebo is administered orally.
Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.
* Able to tolerate topical corticosteroids for atopic dermatitis lesions.
Exclusion Criteria
* 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.
12 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Ichinomiya Municipal Hospital /ID# 205942
Ichinomiya-shi, Aichi-ken, Japan
Central Clinic /ID# 206558
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 207566
Nagoya, Aichi-ken, Japan
Yasumoto Dermatology Clinic /ID# 206480
Chikushino-shi, Fukuoka, Japan
Kiryu Dermatology Clinic /ID# 206044
Fukuoka, Fukuoka, Japan
Medical Corporation Matsuo Clinic /ID# 207323
Fukuoka, Fukuoka, Japan
Matsuda Tomoko Dermatological Clinic /ID# 206288
Fukuoka, Fukuoka, Japan
Higuchi Dermatology Urology Clinic /ID# 206287
Kasuga-shi, Fukuoka, Japan
Central Japan International Medical Center /ID# 205684
Minokamo-shi, Gifu, Japan
Kiryu Kosei General Hospital /ID# 206155
Kiryu-shi, Gunma, Japan
Gunma University Hospital /ID# 207016
Maebashi, Gunma, Japan
Fukuyama City Hospital /ID# 206761
Fukuyama-shi, Hiroshima, Japan
Asahikawa Medical University Hospital /ID# 206521
Asahikawa-shi, Hokkaido, Japan
Medical Corporation Kato Dermatology Clinic /ID# 206561
Sapporo, Hokkaido, Japan
Kitago Dermatology Clinic /ID# 207025
Sapporo, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519
Sapporo, Hokkaido, Japan
Kansai Rosai Hospital /ID# 205918
Amagasaki-shi, Hyōgo, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 206974
Amagasaki-shi, Hyōgo, Japan
Kobe University Hospital /ID# 206200
Kobe, Hyōgo, Japan
Tokai University Hospital /ID# 206657
Isehara-shi, Kanagawa, Japan
Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766
Kawasaki-shi, Kanagawa, Japan
Nippon Medical School Musashi Kosugi Hospital /ID# 206656
Kawasaki-shi, Kanagawa, Japan
Yokohama Rosai Hospital /ID# 206648
Yokohama, Kanagawa, Japan
Suizenji Dermatology Clinic /ID# 205871
Kumamoto, Kumamoto, Japan
Nagasaki University Hospital /ID# 206118
Nagasaki, Nagasaki, Japan
Nagaoka Red Cross Hospital /ID# 209817
Nagaoka-shi, Niigata, Japan
Isonokami dermatological clinic /ID# 206923
Daito-shi, Osaka, Japan
Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704
Neyagawa, Osaka, Japan
Shizuoka General Hospital /ID# 207122
Shizuoka, Shizuoka, Japan
Mildix Skin Clinic /ID# 206829
Adachi-ku, Tokyo, Japan
Yaesu Nihonbashi Skin Clinic /ID# 207125
Chuo-ku, Tokyo, Japan
Fukuwa clinic /ID# 206760
Chuo-ku, Tokyo, Japan
Hosono Clinic /ID# 205953
Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital /ID# 206186
Itabashi-ku, Tokyo, Japan
Mita Dermatology /ID# 206694
Minato-ku, Tokyo, Japan
Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882
Nakano-ku, Tokyo, Japan
Matsuyama Dermatology /ID# 205998
Nakano-ku, Tokyo, Japan
Miu Skin Clinic /ID# 206911
Ōta-ku, Tokyo, Japan
Tokyo Rosai Hospital /ID# 205809
Ōta-ku, Tokyo, Japan
Tampopo Dermatology Clinic /ID# 207013
Ōta-ku, Tokyo, Japan
Naoko Dermatology Clinic /ID# 205334
Setagaya-ku, Tokyo, Japan
Tachikawa Dermatology Clinic /ID# 206996
Tachikawa-shi, Tokyo, Japan
Toyama Prefectural Central Hospital /ID# 206286
Toyama, Toyama, Japan
Countries
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References
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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.
Hayashi 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.
Katoh 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.
Tanaka 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.
Related Links
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clinical study report synopsis
Other Identifiers
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2022-002777-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M17-377
Identifier Type: -
Identifier Source: org_study_id
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