Clinical trial NCT03661138: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Upadacitinib
Topical Corticosteroids
Atopic Dermatitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 272
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants experiencing adverse events
timeFrame: Up to 141 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ichinomiya-shi
country: Japan
facility: Ichinomiya Municipal Hospital /ID# 205942
state: Aichi
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 207566
state: Aichi
city: Nagoya-shi
country: Japan
facility: Central Clinic /ID# 206558
state: Aichi
city: Chikushino-shi
country: Japan
facility: Yasumoto Dermatology Clinic /ID# 206480
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kiryu Dermatology Clinic /ID# 206044
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Medical Corporation Matsuo Clinic /ID# 207323
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Matsuda Tomoko Dermatological Clinic /ID# 206288
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Higuchi Dermatology Urology Clinic /ID# 206287
state: Fukuoka
city: Minokamo-shi
country: Japan
facility: Central Japan International Medical Center /ID# 205684
state: Gifu
city: Kiryu-shi
country: Japan
facility: Kiryu Kosei General Hospital /ID# 206155
state: Gunma
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 207016
state: Gunma
city: Fukuyama-shi
country: Japan
facility: Fukuyama City Hospital /ID# 206761
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Asahikawa Medical University Hospital /ID# 206521
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Medical Corporation Kato Dermatology Clinic /ID# 206561
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Kitago Dermatology Clinic /ID# 207025
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Kansai Rosai Hospital /ID# 205918
state: Hyogo
city: Amagasaki-shi
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center /ID# 206974
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe University Hospital /ID# 206200
state: Hyogo
city: Isehara-shi
country: Japan
facility: Tokai University Hospital /ID# 206657
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital /ID# 206656
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Rosai Hospital /ID# 206648
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Suizenji Dermatology Clinic /ID# 205871
state: Kumamoto
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 206118
state: Nagasaki
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital /ID# 209817
state: Niigata
city: Daito-shi
country: Japan
facility: Isonokami dermatological clinic /ID# 206923
state: Osaka
city: Neyagawa-shi
country: Japan
facility: Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704
state: Osaka
city: Shizuoka-shi
country: Japan
facility: Shizuoka General Hospital /ID# 207122
state: Shizuoka
city: Adachi-ku
country: Japan
facility: Mildix Skin Clinic /ID# 206829
state: Tokyo
city: Chuo-ku
country: Japan
facility: Yaesu Nihonbashi Skin Clinic /ID# 207125
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa clinic /ID# 206760
state: Tokyo
city: Chuo-ku
country: Japan
facility: Hosono Clinic /ID# 205953
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital /ID# 206186
state: Tokyo
city: Minato-ku
country: Japan
facility: Mita Dermatology /ID# 206694
state: Tokyo
city: Nakano-ku
country: Japan
facility: Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882
state: Tokyo
city: Nakano-ku
country: Japan
facility: Matsuyama Dermatology /ID# 205998
state: Tokyo
city: Ota-ku
country: Japan
facility: Miu Skin Clinic /ID# 206911
state: Tokyo
city: Ota-ku
country: Japan
facility: Tokyo Rosai Hospital /ID# 205809
state: Tokyo
city: Ota-ku
country: Japan
facility: Tampopo Dermatology Clinic /ID# 207013
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Naoko Dermatology Clinic /ID# 205334
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Tachikawa Dermatology Clinic /ID# 206996
state: Tokyo
city: Toyama-shi
country: Japan
facility: Toyama Prefectural Central Hospital /ID# 206286
state: Toyama
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.