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

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03661138
Collaborator
(none)
272
43
4
45.5
6.3
0.1

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

Study Type:
Interventional
Actual Enrollment :
272 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 27, 2018
Anticipated Primary Completion Date :
Aug 12, 2022
Anticipated Study Completion Date :
Aug 12, 2022

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:
  • ABT-494
  • 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:
  • ABT-494
  • 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:
  • ABT-494
  • 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:
  • ABT-494
  • 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

    1. 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

    Ages Eligible for Study:
    12 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03661138
    Other Study ID Numbers:
    • M17-377
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 7, 2021