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Atopic DermatitisNCT05029895

A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)

An observational study of Atopic Dermatitis, run by AbbVie at 61 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

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Atopic Dermatitis
How many people
167 participants
Where
61 sitesJapan
Study dates
29 Sep 2021to 17 Sep 2025
Phase
Observational
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Adolescent participants receiving upadacitinib according to the product prescribing information for atopic dermatitis in Japan.

Who may be able to join

  • Participants who are diagnosed with atopic dermatitis (AD).
  • History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD.
  • Participants initiating upadacitinib for the treatment of AD in routine clinical practice.
  • Body weight >=30 kg at the start of dosing.

Who cannot join

  • Prior treatment with upadacitinib
  • Currently participating in another registrational clinical research study
  • Participants for whom upadacitinib is contraindicated

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

Japan61 sites

  • Noriko Dermatology Clinic /ID# 246626

    Akita, Akita, 010-0062

  • Takeo Skin Clinic /ID# 248095

    Asahi Owari, Aichi-ken, 488-0032

  • Fukuoka Children'S Hospital /ID# 245067

    Fukuoka, 813-0017

  • Tokyo Med Univ Hachioji Med Ct /ID# 250958

    Hachioji-shi, Tokyo, 193-0998

  • Hayano Pediatrician Clinic /ID# 250960

    Himeji-shi, Hyōgo, 679-2151

  • Kansai Medical University Hospital /ID# 246020

    Hirakata-shi, Osaka, 573-1191

  • Hiratsuka City Hospital /ID# 245071

    Hiratsuka-shi, Kanagawa, 254-0065

  • Hiroshima University Hospital /ID# 245356

    Hiroshima, Hiroshima, 734-8551

  • Yamaguchi Grand Medical Center /ID# 251659

    Hohu-shi, Yamaguchi, 747-8511

  • Ichinomiya Municipal Hospital /ID# 245070

    Ichinomiya-shi, Aichi-ken, 491-8558

  • Aso Iizuka Hospital /ID# 252145

    Iizuka-shi, Fukuoka, 820-8505

  • Nippon Medical Chiba Hokusoh Hospital /ID# 246627

    Inzai-shi, Chiba, 270-1613

  • Kagoshima City Hospital /ID# 252142

    Kagoshima, Kagoshima-ken, 673-0886

  • Imamura General Hospital /ID# 249526

    Kagoshima, Kagoshima-ken, 890-0064

  • Kagoshima University Hospital /ID# 248732

    Kagoshima, Kagoshima-ken, 890-8520

  • Chutoen General Medical Center /Id# 248741

    Kakegawa-shi, Shizuoka, 436-0040

  • Chutoen General Medical Center /Id# 249522

    Kakegawa-shi, Shizuoka, 436-0040

  • Okada Kodomonomori Clinic /ID# 248096

    Kasukabe-shi, Saitama, 344-0011

  • Saitama Medical Center /ID# 244695

    Kawagoe, Saitama, 350-8550

  • Teikyo University Mizonokuchi Hospital /ID# 252146

    Kawasaki, Kanagawa, 213-8507

  • Kitami Red Cross Hospital /ID# 250838

    Kitami-shi, Hokkaido, 090-0026

  • Kobe City Medical Center General Hospital /ID# 244052

    Kobe, Hyōgo, 650-0047

  • Kobe City Medical Center General Hospital /ID# 250836

    Kobe, Hyōgo, 650-0047

  • Bito Dermatology Clinic /ID# 244093

    Kobe, Hyōgo, 651-0095

  • Hoshi General Hospital /ID# 250959

    Koriyama-shi, Fukushima, 963-8501

  • Dokkyo Medical University Saitama Medical Center /ID# 249525

    Koshigaya, Saitama, 343-0845

  • Kurume University Hospital /ID# 248740

    Kurume-shi, Fukuoka, 830-0011

  • Takeoka Dermatology Clinic /ID# 240610

    Marugame, Kagawa-ken, 763-0074

  • Matsuyama Red Cross Hospital /ID# 248739

    Matsuyama, Ehime, 790-8524

  • Dokkyo Medical University Hospital /ID# 245068

    Mibu, Tochigi, 321-0293

  • Central Japan International Medical Center /ID# 246625

    Minokamo-shi, Gifu, 505-8510

  • Mito Kyodo General Hospital /ID# 243745

    Mito, Ibaraki, 310-0015

  • Kansai Medical University Takii Hospital /ID# 250195

    Moriguchi, Osaka, 570-8507

  • Nagahama Red Cross Hospital /ID# 252136

    Nagahama-shi, Shiga, 526-8585

  • NHO Nagoya Medical Center /ID# 245069

    Nagoya, Aichi-ken, 460-0001

  • Nagoya City University Hospital /ID# 250809

    Nagoya, Aichi-ken, 467-8602

  • Naha City Hospital /ID# 245065

    Naha, Okinawa, 902-0061

  • Torii Dermatology Clinic /ID# 252143

    Nonoichi-shi, Ishikawa-ken, 921-8821

  • Takagi Dermatological Clinic /ID# 241160

    Obihiro-Shi, Hokkaido, 080-0013

  • Aichi Children's Health and Medical Center /ID# 245357

    Obu-shi, Aichi-ken, 474-8710

  • Okayama University Hospital /ID# 252141

    Okayama, Okayama-ken, 700-8558

  • Duplicate_Japanese Red Cross Osaka Hospital /ID# 249524

    Osaka, Osaka, 543-8555

  • Osaka Metropolitan University Hospital /ID# 245972

    Osaka, Osaka, 545-8586

  • Takatsuki General Hospital /ID# 242334

    Osaka

  • Shiga University of Medical Science Hospital /ID# 245969

    Ōtsu, Shiga, 520-2192

  • National Hospital Organization Sagamihara National Hospital /ID# 243744

    Sagamihara-shi, Kanagawa, 252-0392

  • Hino Clinic /ID# 245975

    Sakai-shi, Osaka, 599-8272

  • Hosui General Medical Clinic /ID# 241881

    Sapporo, Hokkaido, 060-0063

  • Duplicate_Kobayashi Skin Clinic /ID# 248006

    Sapporo, Hokkaido, 060-0807

  • National Center For Child Health And Development /ID# 244696

    Setagaya City, Tokyo, 157-8535

  • Tokyo Metropolitan Hiroo Hospital /ID# 250837

    Shibuya Ward, Tokyo, 150-0013

  • Suzuki Kids Clinic /ID# 243743

    Shingū, Wakayama, 647-0042

  • Maekawa Kids Clinic /ID# 249521

    Sichuan, Hyōgo, 666-0017

  • Fraternity Memorial Hospital /ID# 245974

    Sumida-ku, Tokyo, 130-8587

  • Osaka Medical and Pharmaceutical University Hospital /ID# 251660

    Takatsuki-shi, Osaka, 569-8686

  • Tonami General Hospital /ID# 247760

    Tonami-shi, Toyama, 939-1395

  • Sugamo Sengoku Dermatology /ID# 247761

    Toshima City, Tokyo, 170-0002

  • National Mie Hospital /ID# 245066

    Tsu, Mie-ken, 514-0125

  • Wakayama Medical University Hospital /ID# 247498

    Wakayama, Wakayama, 641-8510

  • Kanagawa Children's Medical Center /ID# 252144

    Yokohama, Kanagawa, 232-8555

  • National Hospital Organization Shimoshizu National Hospital /ID# 245064

    Yotsukaido-shi, Chiba, 284-0003

Other trials in Japan

About this study

Official title: A Post-Marketing Observational Study to Evaluate Safety and Effectiveness of Upadacitinib in Adolescent Patients Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to <18 years old in Japan in the real-world setting.

Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to <18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan.

Read more

Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Keywords
Atopic Dermatitis, Atopic Eczema, Upadacitinib, RINVOQ
Medical subject headings
Dermatitis, Atopic

What participants receive

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

Study groups in NCT05029895
Study groupRoleWhat they receive
Participants Receiving UpadacitinibParticipants receiving upadacitinib for atopic dermatitis.

What is being measured

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

  1. Percentage of Participants with Serious Infection

    Serious infection is defined as any infection identified as an Infection Company MedDRA Query that meets seriousness criteria

    Measured: 2 Years

Secondary outcomes (10)

  1. Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) including Safety Specification

    An AE/ADR is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. Safety specification is defined as: serious infections (including TB, pneumonia, pneumocystis pneumonia, pulmonary hemorrhage and opportunistic infections), herpes zoster, VTE (deep venous thrombosis and pulmonary embolus), gastrointestinal perforation, hepatic function disorder, Interstitial lung disease, neutrophil count decreased, lymphocyte count decreased and hemoglobin decreased, hepatitis B virus reactivation, malignancies, major adverse cardiac events, rhabdomyolysis and myopathy, and renal impairment, and safety in pediatric patients and weighing <40 kg.

    Measured: 2 Years

  2. Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) Related to Impact on Bone Growth

    An AE/ADR is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs/treatment-emergent SAEs (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Measured: 2 Years

  3. Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1

    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

    Measured: 2 Years

  4. Absolute Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)

    Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 2 Years

  5. Percent Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)

    Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 2 Years

  6. Percentage of Participants Achieving an Improvement in Worst Pruritus-NRS >=4

    Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: 2 Years

  7. Percentage of Participants Achieving Worst Pruritus-NRS 0/1

    Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: 2 Years

  8. Absolute Change from Baseline in Patient Oriented Eczema Measure (POEM) Score

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD.

    Measured: 2 Years

  9. Percent Change from Baseline in POEM Score

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD.

    Measured: 2 Years

  10. Percentage of Participants Achieving a Clinically Meaningful Improvement in POEM

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD. Minimal Clinically Important Difference=4

    Measured: 2 Years

Timeline

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

  1. First posted1 Sep 2021
  2. Study start29 Sep 2021
  3. Primary completion17 Sep 2025
  4. Study completion17 Sep 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029895
Sponsor's protocol ID
P20-442
Status last verified
Feb 2026
First submitted
30 Aug 2021
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by AbbVie at 61 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 4 inclusion and 3 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 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.

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?

Percentage of Participants with Serious Infection (time frame: 2 Years). 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 NCT05029895.

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 27 Feb 2026.

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