Assessing the effectiveness of Upadacitinib for treating prurigo-type atopic dermatitis in Japan
A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan
This study is testing how well Upadacitinib works for treating moderate to severe prurigo-type atopic dermatitis in teens and adults in Japan over 48 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 1 site (Sendai-shi, Miyagi) |
| Trial ID | NCT05451316 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of Upadacitinib (UPA) in adolescents and adults diagnosed with moderate to severe prurigo-type atopic dermatitis in Japan. Participants will be enrolled based on their physician's decision to prescribe UPA, independent of the study. Approximately 200 participants will receive UPA in a real-world setting for 48 weeks, with a focus on assessing changes in disease activity. The study aims to gather data on the treatment's impact on symptoms such as itching and skin inflammation.
Who should consider this trial
Good fit: Ideal candidates include adolescents and adults with a confirmed diagnosis of moderate to severe prurigo-type atopic dermatitis who are starting treatment with Upadacitinib.
Not a fit: Patients with chronic pruritus from conditions other than atopic dermatitis or those who have previously been treated with Upadacitinib may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Upadacitinib for managing prurigo-type atopic dermatitis, potentially improving treatment options for patients.
How similar studies have performed: While Upadacitinib is an approved treatment for atopic dermatitis, this specific observational approach in a real-world setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sendai-shi, Miyagi
- Tohoku Medical and Pharmaceuti /ID# 252486 — Sendai-shi, Miyagi, Japan (Recruiting)
Study contacts
- Study coordinator: AbbVie GK Clinical Trial Registration Desk
- Email: abbvie_jpn_info_clingov@abbvie.com
- Phone: +81-3-4577-1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.