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Atopic DermatitisPhase 3Start Up JapanNCT06701331

Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis

A Phase 3 study testing Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 25 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Pediatric atopic dermatitis (AD), also known as childhood eczema, is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to assess the change in disease activity (Efficacy) and to assess the safety of upadacitinib in combination with topical corticosteroids… Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
25 sitesJapan
Study dates
22 Dec 2024to Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • A minimum weight of 10 kg and weight and height ≥ -2.0 SD for their age according to Japanese standard growth charts at the Baseline visit.
  • Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline.
  • Eczema Area and Severity Index (EASI) score ≥ 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score ≥ 3; ≥ 10% body surface area (BSA) of AD involvement at the Baseline visit; and Baseline weekly average of daily WIS or WSI-NRS ≥ 4.
  • Participant has applied a topical, additive-free, bland emollient or moisturizer twice daily for at least 7 days before the Baseline visit.
  • Documented history (within 6 months of the Baseline visit) of inadequate response or intolerance to topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) or a systemic immunomodulating therapy, or medical inadvisability of available systemic therapy (e.g., because of important side effects or safety risks).

Who cannot join

  • Participants that have current and/or history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit or that would interfere with the appropriate assessment of AD lesions.
  • Participants that have used topical treatments for AD (except for topical emollient or moisturizer treatments) including but not limited to TCS, TCI, or topical PDE-4 inhibitors, within 7 days of the Baseline visit or any the following prohibited AD treatments within the specified timeframes below prior to the Baseline visit:
  • Systemic therapy for AD, including but not limited to corticosteroids and cyclosporine, within 4 weeks;
  • Targeted biologic treatments within 5 half-lives (if known) or within 12 weeks, whichever is longer;
  • Phototherapy treatment, laser therapy, tanning booth use, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Japan25 sites

  • Fukuwa Clinic /ID# 269203

    Chuo-ku, Tokyo, 103-0031

  • Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192

    Fukuoka, Fukuoka, 814-0171

  • Saruta Dermatology Clinic /ID# 270416

    Fukuoka, Fukuoka, 819-0042

  • Hayami Dermatology Clinic /ID# 269945

    Higashinari-ku, Osaka, 537-0013

  • Aoi Dermatology Clinic /ID# 274265

    Kamimashiki-gun, Kumamoto, 861-2236

  • Tokunaga Skin Clinic /ID# 270189

    Kasuga-shi, Fukuoka, 816-0813

  • Musashikosugi Sasamoto Pediatric And Allergy Clinic /ID# 270381

    Kawasaki-shi, Kanagawa, 211-0004

  • Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 269206

    Kitakyushu-shi, Fukuoka, 807-8556

  • Hirase Allergie Children's Clinic /ID# 271208

    Kobe, Hyōgo, 653-0836

  • Gunma University Hospital /ID# 272319

    Maebashi, Gunma, 371-8511

  • Takeoka Dermatology Clinic /ID# 269199

    Marugame, Kagawa-ken, 763-0074

  • Miyata Dermatology Clinic /ID# 269200

    Matsudo-Shi, Chiba, 271-0092

  • Dokkyo Medical University Hospital /ID# 270367

    Mibu, Tochigi, 321-0293

  • Central Clinic - Nagoya /ID# 269205

    Nagoya, Aichi-ken, 464-0821

  • Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198

    Neyagawa, Osaka, 572-0838

  • Momodani Skin Clinic /ID# 270384

    Osaka, Osaka, 543-0033

  • Jun Dermatology Clinic /ID# 269953

    Osaka, Osaka, 558-0003

  • National Hospital Organization Sagamihara National Hospital /ID# 271575

    Sagamihara, Kanagawa, 252-0315

  • Saitama City Hospital /ID# 271392

    Saitama, 336-8522

  • Dermatology and Ophthalmology Kume Clinic /ID# 271854

    Sakai-shi, Osaka, 593-8324

  • Sapporo Shiroishi Dermatology Clinic /ID# 269691

    Sapporo, Hokkaido, 003-0026

  • Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194

    Setagaya-ku, Tokyo, 157-0066

  • Fujita Health University Hospital /ID# 269201

    Toyoake, Aichi-ken, 470-1192

  • Ryuseidai Children's Clinic /ID# 271400

    Tsukuba, Ibaraki, 305-0008

  • University of Tsukuba Hospital /ID# 271238

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis

Pediatric atopic dermatitis (AD), also known as childhood eczema, is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to assess the change in disease activity (Efficacy) and to assess the safety of upadacitinib in combination with topical corticosteroids (TCS) in pediatric participants 2 to 11 years of age in Japan with moderate to severe AD who are candidates for systemic therapy.

Upadacitinib is approved for the treatment of moderate to severe AD in adults and adolescents 12 years of age and older in many countries, including Japan. This study comprises a 35-day screening period; a 12-week, randomized, double-blind treatment period where there will be a 1 in 2 chance that a participant is assigned placebo. This will be followed by an open-label upadacitinib treatment period up to Week 52.

Read more

Around 98 participants will be enrolled in the study at approximately 35 sites in Japan.

Participants will receive upadacitinib oral tablets, or matching placebo, once daily (or an adult equivalent oral solution dose twice a day) for up to 52 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Placebo, Upadacitinib
Keywords
Upadacitinib
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • PlaceboDrug

    Also called ABT-494, RINVOQ®

    Tablets taken orally once a day (Or equivalent oral solution taken two times a day)

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ®

    Tablets taken orally once a day (Or equivalent oral solution taken two times a day)

Study groups in NCT06701331
Study groupRoleWhat they receive
Upadacitinib + Topical Corticosteroids (TCS)ExperimentalParticipants will be randomized to receive the upadacitinib daily adult equivalent dose in combination with TCS once a day (QD) during the double-blind and open label treatment periods for a total of 52 weeks
Receives: Drug: Upadacitinib
Placebo / Upadacitinib + Topical Corticosteroids (TCS)Placebo comparatorParticipants will receive placebo orally once a day (QD) in combination with TCS for 12 weeks in the double-blind treatment period. At Week 12 participants will then be switched to receive open-label upadacitinib daily adult equivalent dose in combination with TCS.
Receives: Drug: Placebo; Drug: Upadacitinib

What is being measured

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

  1. Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1],

    An EASI 75 response is defined as a 75% reduction (improvement) from Baseline in EASI score.

    Measured: At Week 12

  2. Number of Participants With Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.

    Measured: From first dose of study drug until 30 days following last dose of study drug (up to approximately 56 weeks)

Secondary outcomes (3)

  1. Percentage of participants achieving validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) 0/1 with a reduction from Baseline of ≥ 2 points

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: At Week 12

  2. Percentage of participants achieving an improved (reduced) weekly average Worst Itch Scale (WIS) score of ≥ 4 from Baseline for participants equal or greater than 6 years old with a weekly average WIS of ≥ 4 at Baseline

    The WIS is an assessment tool that participants use to report the intensity of their pruritus. Using an 11-point scale (0 to 10) where 0 indicates no itching and 10 indicates worst itching possible, participants are asked 2 questions: "What was the worst itch you had today?" and "What was the worst itch you had last night?" The WIS will be administered to participants ≥ 6 years of age at the time of the Baseline visit.

    Measured: At Week 12

  3. Percentage of participants achieving an improved (reduced) weekly average Worst Scratch/Itch numerical rating scale (WIS-NRS) score of ≥ 4 from Baseline for participants less than 6 years old with a weekly average WIS of ≥ 4 at Baseline

    The WSI-NRS is an assessment tool that evaluates a participants scratching and itching intensity at its worst in the past 24 hours as assessed by the participants parent/legally authorized representative. Intensity is assessed on an 11-point scale (0 to 10) where 0 indicates no scratching/itching and 10 indicates worst scratching/itching possible.

    Measured: At Week 12

Timeline

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

  1. First posted22 Nov 2024
  2. Study start22 Dec 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06701331
Sponsor's protocol ID
M25-145
Acronym
Start Up Japan
Status last verified
Feb 2026
First submitted
21 Nov 2024
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 25 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 23 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 25 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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 Achieving Eczema Area and Severity Index (EASI) 75 (time frame: At Week 12). The study lists 2 primary outcomes in all. 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 NCT06701331.

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 23 Feb 2026.

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