A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2026
  • participants needed
    170
  • sponsor
    AbbVie
Updated on 1 July 2022
tacrolimus
eczema
topical steroids
inflammatory dermatosis
upadacitinib
topical agents

Summary

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to <18 years old in Japan in the real-world setting.

Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to <18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan.

Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Details
Condition Atopic Dermatitis
Clinical Study IdentifierNCT05029895
SponsorAbbVie
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who are diagnosed with atopic dermatitis (AD)
History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD
Participants initiating upadacitinib for the treatment of AD in routine clinical practice
Body weight >=30 kg at the start of dosing

Exclusion Criteria

Prior treatment with upadacitinib
Currently participating in another registrational clinical research study
Participants for whom upadacitinib is contraindicated
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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