A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— Rising Up  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661138
• Other study ID #: M17-377
• Secondary ID: 2022-002777-29
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2018
• Est. completion date: August 19, 2022

Study information

• Verified date: February 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Upadacitinib
Upadacitinib is administered orally.
• Placebo for upadacitinib
Placebo is administered orally.
• Topical Corticosteroids (TCS)
It is administered concomitantly with upadacitinib or placebo.

Locations

Country	Name	City	State
Japan	Mildix Skin Clinic /ID# 206829	Adachi-ku	Tokyo
Japan	Hyogo Prefectural Amagasaki General Medical Center /ID# 206974	Amagasaki-shi	Hyogo
Japan	Kansai Rosai Hospital /ID# 205918	Amagasaki-shi	Hyogo
Japan	Asahikawa Medical University Hospital /ID# 206521	Asahikawa-shi	Hokkaido
Japan	Yasumoto Dermatology Clinic /ID# 206480	Chikushino-shi	Fukuoka
Japan	Fukuwa clinic /ID# 206760	Chuo-ku	Tokyo
Japan	Hosono Clinic /ID# 205953	Chuo-ku	Tokyo
Japan	Yaesu Nihonbashi Skin Clinic /ID# 207125	Chuo-ku	Tokyo
Japan	Isonokami dermatological clinic /ID# 206923	Daito-shi	Osaka
Japan	Kiryu Dermatology Clinic /ID# 206044	Fukuoka-shi	Fukuoka
Japan	Matsuda Tomoko Dermatological Clinic /ID# 206288	Fukuoka-shi	Fukuoka
Japan	Medical Corporation Matsuo Clinic /ID# 207323	Fukuoka-shi	Fukuoka
Japan	Fukuyama City Hospital /ID# 206761	Fukuyama-shi	Hiroshima
Japan	Ichinomiya Municipal Hospital /ID# 205942	Ichinomiya-shi	Aichi
Japan	Tokai University Hospital /ID# 206657	Isehara-shi	Kanagawa
Japan	Nihon University Itabashi Hospital /ID# 206186	Itabashi-ku	Tokyo
Japan	Higuchi Dermatology Urology Clinic /ID# 206287	Kasuga-shi	Fukuoka
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	Kiryu Kosei General Hospital /ID# 206155	Kiryu-shi	Gunma
Japan	Kobe University Hospital /ID# 206200	Kobe-shi	Hyogo
Japan	Suizenji Dermatology Clinic /ID# 205871	Kumamoto-shi	Kumamoto
Japan	Gunma University Hospital /ID# 207016	Maebashi-shi	Gunma
Japan	Mita Dermatology /ID# 206694	Minato-ku	Tokyo
Japan	Central Japan International Medical Center /ID# 205684	Minokamo-shi	Gifu
Japan	Nagaoka Red Cross Hospital /ID# 209817	Nagaoka-shi	Niigata
Japan	Nagasaki University Hospital /ID# 206118	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital /ID# 207566	Nagoya shi	Aichi
Japan	Central Clinic /ID# 206558	Nagoya-shi	Aichi
Japan	Matsuyama Dermatology /ID# 205998	Nakano-ku	Tokyo
Japan	Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882	Nakano-ku	Tokyo
Japan	Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704	Neyagawa-shi	Osaka
Japan	Miu Skin Clinic /ID# 206911	Ota-ku	Tokyo
Japan	Tampopo Dermatology Clinic /ID# 207013	Ota-ku	Tokyo
Japan	Tokyo Rosai Hospital /ID# 205809	Ota-ku	Tokyo
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519	Sapporo-shi	Hokkaido
Japan	Kitago Dermatology Clinic /ID# 207025	Sapporo-shi	Hokkaido
Japan	Medical Corporation Kato Dermatology Clinic /ID# 206561	Sapporo-shi	Hokkaido
Japan	Naoko Dermatology Clinic /ID# 205334	Setagaya-ku	Tokyo
Japan	Shizuoka General Hospital /ID# 207122	Shizuoka-shi	Shizuoka
Japan	Tachikawa Dermatology Clinic /ID# 206996	Tachikawa-shi	Tokyo
Japan	Toyama Prefectural Central Hospital /ID# 206286	Toyama-shi	Toyama
Japan	Yokohama Rosai Hospital /ID# 206648	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   clinical study report synopsis