NCT06701331Active, not recruitingPhase 3
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, 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
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 21 Nov 2024
- Start date
- 22 Dec 2024
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- AbbVie
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06701331
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 99
- From 22 Dec 2024 to the primary completion date, 31 Jan 2027
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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).
Age in the registry: 2 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fukuwa Clinic /ID# 269203 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Saruta Dermatology Clinic /ID# 270416 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hayami Dermatology Clinic /ID# 269945 Coordinator of this site? Confirm its status | Higashinari-ku | Japan | Unknown status |
| Aoi Dermatology Clinic /ID# 274265 Coordinator of this site? Confirm its status | Kamimashiki-gun | Japan | Unknown status |
| Tokunaga Skin Clinic /ID# 270189 Coordinator of this site? Confirm its status | Kasuga-shi | Japan | Unknown status |
| Musashikosugi Sasamoto Pediatric And Allergy Clinic /ID# 270381 Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Unknown status |
| Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 269206 Coordinator of this site? Confirm its status | Kitakyushu-shi | Japan | Unknown status |
| Hirase Allergie Children's Clinic /ID# 271208 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Gunma University Hospital /ID# 272319 Coordinator of this site? Confirm its status | Maebashi | Japan | Unknown status |
| Takeoka Dermatology Clinic /ID# 269199 Coordinator of this site? Confirm its status | Marugame | Japan | Unknown status |
| Miyata Dermatology Clinic /ID# 269200 Coordinator of this site? Confirm its status | Matsudo-Shi | Japan | Unknown status |
| Dokkyo Medical University Hospital /ID# 270367 Coordinator of this site? Confirm its status | Mibu | Japan | Unknown status |
| Central Clinic - Nagoya /ID# 269205 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198 Coordinator of this site? Confirm its status | Neyagawa | Japan | Unknown status |
| Jun Dermatology Clinic /ID# 269953 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Momodani Skin Clinic /ID# 270384 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| National Hospital Organization Sagamihara National Hospital /ID# 271575 Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Saitama City Hospital /ID# 271392 Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Dermatology and Ophthalmology Kume Clinic /ID# 271854 Coordinator of this site? Confirm its status | Sakai-shi | Japan | Unknown status |
| Sapporo Shiroishi Dermatology Clinic /ID# 269691 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194 Coordinator of this site? Confirm its status | Setagaya-ku | Japan | Unknown status |
| Fujita Health University Hospital /ID# 269201 Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Ryuseidai Children's Clinic /ID# 271400 Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
| University of Tsukuba Hospital /ID# 271238 Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.