A Study to Assess Change in Disease Activity in Adolescents and Adults With Moderate to Severe Prurigo-type Atopic Dermatitis in Japan Who Are Treated With Oral Upadacitinib

Launched by ABBVIE · Jul 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called upadacitinib (UPA) for treating moderate to severe atopic dermatitis (AD) with a specific focus on a type called prurigo-type AD, which causes intense itching and sometimes painful bumps on the skin. The trial will take place in Japan and will include around 200 participants, both adolescents and adults, who have been diagnosed with this skin condition. If you or a loved one have had AD for over a year and are experiencing significant itching, you might be eligible to join the study if your doctor has prescribed UPA as part of your treatment.

Participants in this study will take UPA in the form of a daily pill for 48 weeks and will attend regular check-ups at a hospital or clinic to monitor their progress. It’s important to note that joining this study won’t add any extra burden compared to the usual care you would receive for your condition. The decision to use UPA will be made by the doctor before the study starts, and there are specific criteria to ensure the safety and appropriateness of the treatment for participants. If you’re interested or want to learn more, it’s a good idea to talk to your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • Physician confirmed diagnosis of moderate to severe atopic dermatitis (AD) at baseline
• • AD symptom onset \> 1 year prior to baseline
• • Initiation of UPA treatment for AD is indicated and prescribed per the label in Japan
• • Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at baseline
• • Presence of palpable prurigo nodules at baseline
• Exclusion Criteria:
• • Prior treatment with UPA
• • Contraindications to UPA
• • Chronic pruritus resulting from another condition (e.g., neuropathic disorders) than AD, prurigo nodularis (PN)
• • PN caused by medication, metal allergy, infection, insect bite
• • Current participation in interventional research