Rising Up: A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
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:
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:
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:
Drug: Placebo for upadacitinib
Placebo is administered orally.
Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
|
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:
Drug: Placebo for upadacitinib
Placebo is administered orally.
Drug: Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.
|
Outcome Measures
Primary Outcome Measures
- Number of participants experiencing adverse events [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.
Eligibility Criteria
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.
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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.
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Requirement of prohibited medications during the study.
-
Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ichinomiya Municipal Hospital /ID# 205942 | Ichinomiya-shi | Aichi | Japan | 491-8558 |
2 | Nagoya City University Hospital /ID# 207566 | Nagoya shi | Aichi | Japan | 467-8602 |
3 | Central Clinic /ID# 206558 | Nagoya-shi | Aichi | Japan | 464-0821 |
4 | Yasumoto Dermatology Clinic /ID# 206480 | Chikushino-shi | Fukuoka | Japan | 818-0083 |
5 | Kiryu Dermatology Clinic /ID# 206044 | Fukuoka-shi | Fukuoka | Japan | 813-0044 |
6 | Medical Corporation Matsuo Clinic /ID# 207323 | Fukuoka-shi | Fukuoka | Japan | 819-0373 |
7 | Matsuda Tomoko Dermatological Clinic /ID# 206288 | Fukuoka-shi | Fukuoka | Japan | 8190167 |
8 | Higuchi Dermatology Urology Clinic /ID# 206287 | Kasuga-shi | Fukuoka | Japan | 816-0802 |
9 | Social Medeical Corporation Koseikai Kizawa Memorial Hospital /ID# 205684 | Minokamo-shi | Gifu | Japan | 505-0034 |
10 | Kiryu Kosei General Hospital /ID# 206155 | Kiryu-shi | Gunma | Japan | 376-0024 |
11 | Gunma University Hospital /ID# 207016 | Maebashi-shi | Gunma | Japan | 371-8511 |
12 | Fukuyama City Hospital /ID# 206761 | Fukuyama-shi | Hiroshima | Japan | 721-8511 |
13 | Asahikawa Medical University Hospital /ID# 206521 | Asahikawa-shi | Hokkaido | Japan | 078-8510 |
14 | Medical Corporation Kato Dermatology Clinic /ID# 206561 | Sapporo-shi | Hokkaido | Japan | 003-0026 |
15 | Kitago Dermatology Clinic /ID# 207025 | Sapporo-shi | Hokkaido | Japan | 003-0833 |
16 | Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519 | Sapporo-shi | Hokkaido | Japan | 060-0033 |
17 | Kansai Rosai Hospital /ID# 205918 | Amagasaki-shi | Hyogo | Japan | 660-8511 |
18 | Hyogo Prefectural Amagasaki General Medical Center /ID# 206974 | Amagasaki-shi | Hyogo | Japan | 660-8550 |
19 | Kobe University Hospital /ID# 206200 | Kobe-shi | Hyogo | Japan | 650-0017 |
20 | Tokai University Hospital /ID# 206657 | Isehara-shi | Kanagawa | Japan | 259-1193 |
21 | Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766 | Kawasaki-shi | Kanagawa | Japan | 211-0063 |
22 | Nippon Medical School Musashi Kosugi Hospital /ID# 206656 | Kawasaki-shi | Kanagawa | Japan | 211-8533 |
23 | Yokohama Rosai Hospital /ID# 206648 | Yokohama-shi | Kanagawa | Japan | 222-0036 |
24 | Suizenji Dermatology Clinic /ID# 205871 | Kumamoto-shi | Kumamoto | Japan | 862-0950 |
25 | Nagasaki University Hospital /ID# 206118 | Nagasaki-shi | Nagasaki | Japan | 852-8501 |
26 | Nagaoka Red Cross Hospital /ID# 209817 | Nagaoka-shi | Niigata | Japan | 940-2085 |
27 | Isonokami dermatological clinic /ID# 206923 | Daito-shi | Osaka | Japan | 574-0046 |
28 | Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704 | Neyagawa-shi | Osaka | Japan | 572-0838 |
29 | Shizuoka General Hospital /ID# 207122 | Shizuoka-shi | Shizuoka | Japan | 420-8527 |
30 | Mildix Skin Clinic /ID# 206829 | Adachi-ku | Tokyo | Japan | 120-0034 |
31 | Yaesu Nihonbashi Skin Clinic /ID# 207125 | Chuo-ku | Tokyo | Japan | 103-0028 |
32 | Fukuwa clinic /ID# 206760 | Chuo-ku | Tokyo | Japan | 103-0031 |
33 | Hosono Clinic /ID# 205953 | Chuo-ku | Tokyo | Japan | 104-0031 |
34 | Nihon University Itabashi Hospital /ID# 206186 | Itabashi-ku | Tokyo | Japan | 173-8610 |
35 | Mita Dermatology /ID# 206694 | Minato-ku | Tokyo | Japan | 108-0014 |
36 | Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882 | Nakano-ku | Tokyo | Japan | 164-0001 |
37 | Matsuyama Dermatology /ID# 205998 | Nakano-ku | Tokyo | Japan | 165-0026 |
38 | Miu Skin Clinic /ID# 206911 | Ota-ku | Tokyo | Japan | 114-0052 |
39 | Tokyo Rosai Hospital /ID# 205809 | Ota-ku | Tokyo | Japan | 143-0013 |
40 | Tampopo Dermatology Clinic /ID# 207013 | Ota-ku | Tokyo | Japan | 1430023 |
41 | Naoko Dermatology Clinic /ID# 205334 | Setagaya-ku | Tokyo | Japan | 158-0097 |
42 | Tachikawa Dermatology Clinic /ID# 206996 | Tachikawa-shi | Tokyo | Japan | 1900023 |
43 | Toyama Prefectural Central Hospital /ID# 206286 | Toyama-shi | Toyama | Japan | 930-8550 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M17-377