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Atopic DermatitisPhase 3Rising UpNCT03661138

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

A Phase 3 study testing Upadacitinib and Topical Corticosteroids (TCS) in people with Atopic Dermatitis, run by AbbVie at 43 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Upadacitinib and Topical Corticosteroids (TCS)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
43 sitesJapan
Study dates
27 Oct 2018to 19 Aug 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Japan43 sites

  • Mildix Skin Clinic /ID# 206829

    Adachi-ku, Tokyo, 120-0034

  • Kansai Rosai Hospital /ID# 205918

    Amagasaki-shi, Hyōgo, 660-8511

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 206974

    Amagasaki-shi, Hyōgo, 660-8550

  • Asahikawa Medical University Hospital /ID# 206521

    Asahikawa-shi, Hokkaido, 078-8510

  • Yasumoto Dermatology Clinic /ID# 206480

    Chikushino-shi, Fukuoka, 818-0083

  • Yaesu Nihonbashi Skin Clinic /ID# 207125

    Chuo-ku, Tokyo, 103-0028

  • Fukuwa clinic /ID# 206760

    Chuo-ku, Tokyo, 103-0031

  • Hosono Clinic /ID# 205953

    Chuo-ku, Tokyo, 104-0031

  • Isonokami dermatological clinic /ID# 206923

    Daito-shi, Osaka, 574-0046

  • Kiryu Dermatology Clinic /ID# 206044

    Fukuoka, Fukuoka, 813-0044

  • Medical Corporation Matsuo Clinic /ID# 207323

    Fukuoka, Fukuoka, 819-0373

  • Matsuda Tomoko Dermatological Clinic /ID# 206288

    Fukuoka, Fukuoka, 8190167

  • Fukuyama City Hospital /ID# 206761

    Fukuyama-shi, Hiroshima, 721-8511

  • Ichinomiya Municipal Hospital /ID# 205942

    Ichinomiya-shi, Aichi-ken, 491-8558

  • Tokai University Hospital /ID# 206657

    Isehara-shi, Kanagawa, 259-1193

  • Higuchi Dermatology Urology Clinic /ID# 206287

    Kasuga-shi, Fukuoka, 816-0802

  • Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766

    Kawasaki-shi, Kanagawa, 211-0063

  • Nippon Medical School Musashi Kosugi Hospital /ID# 206656

    Kawasaki-shi, Kanagawa, 211-8533

  • Kiryu Kosei General Hospital /ID# 206155

    Kiryu-shi, Gunma, 376-0024

  • Kobe University Hospital /ID# 206200

    Kobe, Hyōgo, 650-0017

  • Suizenji Dermatology Clinic /ID# 205871

    Kumamoto, Kumamoto, 862-0950

  • Gunma University Hospital /ID# 207016

    Maebashi, Gunma, 371-8511

  • Mita Dermatology /ID# 206694

    Minato-ku, Tokyo, 108-0014

  • Central Japan International Medical Center /ID# 205684

    Minokamo-shi, Gifu, 505-8510

  • Nagaoka Red Cross Hospital /ID# 209817

    Nagaoka-shi, Niigata, 940-2085

  • Nagasaki University Hospital /ID# 206118

    Nagasaki, Nagasaki, 852-8501

  • Central Clinic /ID# 206558

    Nagoya, Aichi-ken, 464-0821

  • Nagoya City University Hospital /ID# 207566

    Nagoya, Aichi-ken, 467-8602

  • Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882

    Nakano-ku, Tokyo, 164-0001

  • Matsuyama Dermatology /ID# 205998

    Nakano-ku, Tokyo, 165-0026

  • Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704

    Neyagawa, Osaka, 572-0838

  • Miu Skin Clinic /ID# 206911

    Ōta-ku, Tokyo, 114-0052

  • Tokyo Rosai Hospital /ID# 205809

    Ōta-ku, Tokyo, 143-0013

  • Tampopo Dermatology Clinic /ID# 207013

    Ōta-ku, Tokyo, 1430023

  • Medical Corporation Kato Dermatology Clinic /ID# 206561

    Sapporo, Hokkaido, 003-0026

  • Kitago Dermatology Clinic /ID# 207025

    Sapporo, Hokkaido, 003-0833

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519

    Sapporo, Hokkaido, 060-0033

  • Naoko Dermatology Clinic /ID# 205334

    Setagaya-ku, Tokyo, 158-0097

  • Shizuoka General Hospital /ID# 207122

    Shizuoka, Shizuoka, 420-8527

  • Nihon University Itabashi Hospital /ID# 206186

    tabashi City, Tokyo, 173-8610

  • Tachikawa Dermatology Clinic /ID# 206996

    Tachikawa-shi, Tokyo, 1900023

  • Toyama Prefectural Central Hospital /ID# 206286

    Toyama, Toyama, 930-8550

  • Yokohama Rosai Hospital /ID# 206648

    Yokohama, Kanagawa, 222-0036

Other trials in Japan

About this study

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

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.

Being tested
Upadacitinib, Placebo for upadacitinib, Topical Corticosteroids (TCS)
Keywords
Upadacitinib, Topical Corticosteroids, Atopic Dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called ABT-494

    Upadacitinib is administered orally.

  • Placebo for upadacitinibDrug

    Placebo is administered orally.

  • Topical Corticosteroids (TCS)Drug

    It is administered concomitantly with upadacitinib or placebo.

Study groups in NCT03661138
Study groupRoleWhat they receive
Arm AExperimentalUpadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
Receives: Drug: Upadacitinib; Drug: Topical Corticosteroids (TCS)
Arm BExperimentalUpadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
Receives: Drug: Upadacitinib; Drug: Topical Corticosteroids (TCS)
Arm CExperimentalPlacebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
Receives: Drug: Upadacitinib; Drug: Placebo for upadacitinib; Drug: Topical Corticosteroids (TCS)
Arm DExperimentalPlacebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
Receives: Drug: Upadacitinib; Drug: Placebo for upadacitinib; Drug: Topical Corticosteroids (TCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 141 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start27 Oct 2018
  3. Primary completion19 Aug 2022
  4. Study completion19 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03661138
Sponsor's protocol ID
M17-377
Other IDs
2022-002777-29
Acronym
Rising Up
Status last verified
Feb 2023
First submitted
5 Sep 2018
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • 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.

    PubMed 38127188

  • 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.

    PubMed 37356075

  • 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.

    PubMed 36401761

  • 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.

    PubMed 36185549

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib and Topical Corticosteroids (TCS) in people with Atopic Dermatitis, run by AbbVie at 43 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants experiencing adverse events (time frame: Up to 141 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03661138, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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