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)

Launched by ABBVIE · Aug 30, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a medication called upadacitinib for treating atopic dermatitis (AD), a skin condition that causes inflammation and itching. The study specifically focuses on adolescents aged 12 to under 18 years old in Japan, as previous research had limited participation from this age group. About 170 young people who have already been prescribed upadacitinib will take part in this study, which will last for around two years.

To be eligible, participants need to have a diagnosis of atopic dermatitis and have previously used topical treatments like creams or ointments for their condition. They should also weigh at least 30 kg (about 66 pounds) when starting the medication. Throughout the study, participants will continue their regular visits to their healthcare provider and fill out questionnaires to share their experiences. Importantly, joining this study will not add any extra burden compared to their usual care; they will simply be monitored more closely to help gather valuable information about the medication's effects in a real-world setting.

Gender

ALL

Eligibility criteria

• 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