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Could a daily pill tame severe eczema in kids?

NCT ID NCT06701331

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether upadacitinib (Rinvoq), a daily pill already used in older patients, can safely improve moderate to severe eczema in children aged 2 to 11 in Japan. About 99 kids will receive either the drug or a placebo, plus a steroid cream, for up to a year. Researchers will measure skin clearing and watch for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib (Rinvoq) taken as a tablet or oral solution
What this could lead to
If it works, this could offer a new treatment option for children with stubborn eczema that isn't controlled by creams alone.
What could go wrong
This is a relatively small, early-phase study in Japan only. Upadacitinib has known risks like infections and allergic reactions, and it's not yet proven for this age group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

99 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Aoi Dermatology Clinic /ID# 274265

    Kamimashiki-gun, Kumamoto, 861-2236, Japan

  • Central Clinic - Nagoya /ID# 269205

    Nagoya, Aichi-ken, 464-0821, Japan

  • Dermatology and Ophthalmology Kume Clinic /ID# 271854

    Sakai-shi, Osaka, 593-8324, Japan

  • Dokkyo Medical University Hospital /ID# 270367

    Mibu, Tochigi, 321-0293, Japan

  • Fujita Health University Hospital /ID# 269201

    Toyoake, Aichi-ken, 470-1192, Japan

  • Fukuwa Clinic /ID# 269203

    Chuo-ku, Tokyo, 103-0031, Japan

  • Gunma University Hospital /ID# 272319

    Maebashi, Gunma, 371-8511, Japan

  • Hayami Dermatology Clinic /ID# 269945

    Higashinari-ku, Osaka, 537-0013, Japan

  • Hirase Allergie Children's Clinic /ID# 271208

    Kobe, Hyōgo, 653-0836, Japan

  • Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192

    Fukuoka, Fukuoka, 814-0171, Japan

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

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • Jun Dermatology Clinic /ID# 269953

    Osaka, Osaka, 558-0003, Japan

  • Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198

    Neyagawa, Osaka, 572-0838, Japan

  • Miyata Dermatology Clinic /ID# 269200

    Matsudo-Shi, Chiba, 271-0092, Japan

  • Momodani Skin Clinic /ID# 270384

    Osaka, Osaka, 543-0033, Japan

  • Musashikosugi Sasamoto Pediatric And Allergy Clinic /ID# 270381

    Kawasaki-shi, Kanagawa, 211-0004, Japan

  • National Hospital Organization Sagamihara National Hospital /ID# 271575

    Sagamihara, Kanagawa, 252-0315, Japan

  • Ryuseidai Children's Clinic /ID# 271400

    Tsukuba, Ibaraki, 305-0008, Japan

  • Saitama City Hospital /ID# 271392

    Saitama, 336-8522, Japan

  • Sapporo Shiroishi Dermatology Clinic /ID# 269691

    Sapporo, Hokkaido, 003-0026, Japan

  • Saruta Dermatology Clinic /ID# 270416

    Fukuoka, Fukuoka, 819-0042, Japan

  • Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194

    Setagaya-ku, Tokyo, 157-0066, Japan

  • Takeoka Dermatology Clinic /ID# 269199

    Marugame, Kagawa-ken, 763-0074, Japan

  • Tokunaga Skin Clinic /ID# 270189

    Kasuga-shi, Fukuoka, 816-0813, Japan

  • University of Tsukuba Hospital /ID# 271238

    Tsukuba, Ibaraki, 305-8576, Japan

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Other studies related to the condition(s) this trial covers.