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

NCT06701331 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: M25-145
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 25

Brief 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 (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.

Conditions

Atopic Dermatitis

Keywords

Upadacitinib

Outcome Measures

Primary Outcomes (2)

• 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.

  At Week 12

• 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.

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

Secondary Outcomes (3)

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

  At Week 12

• 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

  At Week 12

• 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

  At Week 12

Study Arms (2)

Upadacitinib + Topical Corticosteroids (TCS)

EXPERIMENTAL

Participants 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

Drug: Upadacitinib

Placebo / Upadacitinib + Topical Corticosteroids (TCS)

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo; Drug: Upadacitinib

Interventions

Placebo DRUG

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

Also known as: ABT-494, RINVOQ®

Placebo / Upadacitinib + Topical Corticosteroids (TCS)

Upadacitinib DRUG

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

Also known as: ABT-494, RINVOQ®

Placebo / Upadacitinib + Topical Corticosteroids (TCS); Upadacitinib + Topical Corticosteroids (TCS)

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (25)

Central Clinic - Nagoya /ID# 269205

Nagoya, Aichi-ken, 464-0821, Japan

Location

Fujita Health University Hospital /ID# 269201

Toyoake, Aichi-ken, 470-1192, Japan

Location

Miyata Dermatology Clinic /ID# 269200

Matsudo-Shi, Chiba, 271-0092, Japan

Location

Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192

Fukuoka, Fukuoka, 814-0171, Japan

Location

Saruta Dermatology Clinic /ID# 270416

Fukuoka, Fukuoka, 819-0042, Japan

Location

Tokunaga Skin Clinic /ID# 270189

Kasuga-shi, Fukuoka, 816-0813, Japan

Location

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

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Gunma University Hospital /ID# 272319

Maebashi, Gunma, 371-8511, Japan

Location

Sapporo Shiroishi Dermatology Clinic /ID# 269691

Sapporo, Hokkaido, 003-0026, Japan

Location

Hirase Allergie Children's Clinic /ID# 271208

Kobe, Hyōgo, 653-0836, Japan

Location

Ryuseidai Children's Clinic /ID# 271400

Tsukuba, Ibaraki, 305-0008, Japan

Location

University of Tsukuba Hospital /ID# 271238

Tsukuba, Ibaraki, 305-8576, Japan

Location

Takeoka Dermatology Clinic /ID# 269199

Marugame, Kagawa-ken, 763-0074, Japan

Location

Musashikosugi Sasamoto Pediatric And Allergy Clinic /ID# 270381

Kawasaki-shi, Kanagawa, 211-0004, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 271575

Sagamihara, Kanagawa, 252-0315, Japan

Location

Aoi Dermatology Clinic /ID# 274265

Kamimashiki-gun, Kumamoto, 861-2236, Japan

Location

Hayami Dermatology Clinic /ID# 269945

Higashinari-ku, Osaka, 537-0013, Japan

Location

Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198

Neyagawa, Osaka, 572-0838, Japan

Location

Momodani Skin Clinic /ID# 270384

Osaka, Osaka, 543-0033, Japan

Location

Jun Dermatology Clinic /ID# 269953

Osaka, Osaka, 558-0003, Japan

Location

Dermatology and Ophthalmology Kume Clinic /ID# 271854

Sakai-shi, Osaka, 593-8324, Japan

Location

Dokkyo Medical University Hospital /ID# 270367

Mibu, Tochigi, 321-0293, Japan

Location

Fukuwa Clinic /ID# 269203

Chuo-ku, Tokyo, 103-0031, Japan

Location

Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194

Setagaya-ku, Tokyo, 157-0066, Japan

Location

Saitama City Hospital /ID# 271392

Saitama, 336-8522, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 22, 2024
• Study Start: December 22, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (25)