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

Sponsor
AbbVie
Study ID
NCT06701331
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Tablets taken orally once a day (Or equivalent oral solution taken two times a day)
  • Upadacitinib — DRUG
    Tablets taken orally once a day (Or equivalent oral solution taken two times a day)

Study Details

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.

Key Dates

Start date
Dec 22, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib + Topical Corticosteroids (TCS)
    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
  • Placebo Comparator: Placebo / Upadacitinib + Topical Corticosteroids (TCS)
    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.

Primary Outcome Measure

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75 [ Time Frame: At Week 12 ]

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