Clinical trial NCT06701331: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 98
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
timeFrame: At Week 12
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 56 weeks)
Secondary outcomes:
measure: Percentage of participants achieving validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) 0/1 with a reduction from Baseline of ≥ 2 points
timeFrame: At Week 12
measure: 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
timeFrame: At Week 12
measure: 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
timeFrame: At Week 12
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Central Clinic /ID# 269205
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital /ID# 269201
state: Aichi
city: Matsudo-Shi
country: Japan
facility: Miyata Dermatology Clinic /ID# 269200
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Saruta Dermatology Clinic /ID# 270416
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Tokunaga Skin Clinic /ID# 270189
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 269206
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma University Hospital /ID# 272319
state: Gunma
city: Sapporo-shi
country: Japan
facility: Sapporo Shiroishi Dermatology Clinic /ID# 269691
state: Hokkaido
city: Kobe
country: Japan
facility: Hirase Allergie Children's Clinic /ID# 271208
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital /ID# 271238
state: Ibaraki
city: Tsukuba
country: Japan
facility: Ryuseidai Children's Clinic /ID# 271400
state: Ibaraki
city: Marugame
country: Japan
facility: Takeoka Dermatology Clinic /ID# 269199
state: Kagawa
city: Kawasaki-shi
country: Japan
facility: Musashikosugi Sasamoto Pediatric and Allergy Clinic /ID# 270381
state: Kanagawa
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital /ID# 271575
state: Kanagawa
city: Kamimashiki-gun
country: Japan
facility: Aoi Dermatology Clinic /ID# 274265
state: Kumamoto
city: Neyagawa-shi
country: Japan
facility: Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198
state: Osaka
city: Osaka-shi
country: Japan
facility: Hayami Dermatology Clinic /ID# 269945
state: Osaka
city: Osaka-shi
country: Japan
facility: Momodani Skin Clinic /ID# 270384
state: Osaka
city: Osaka-shi
country: Japan
facility: Medical corporation Jun Dermatology Clinic /ID# 269953
state: Osaka
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic /ID# 271854
state: Osaka
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital /ID# 270367
state: Tochigi
city: Chuo-ku
country: Japan
facility: Fukuwa clinic /ID# 269203
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194
state: Tokyo
city: Saitama
country: Japan
facility: Saitama City Hospital /ID# 271392
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: