NCT05451316Completed
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
A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. In this study, the effectiveness of upadacitinib (UPA) will be assessed in participants with prurigo-type AD in a real world (RW) setting in Japan. UPA is an approved drug for the treatment of AD. Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study. The doctor's decision to prescribe UPA will be made prior to and independently of study participation. Approximately 200 participants will be enrolled in the study at 10 sites in Japan. Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks. 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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1 (actual)
- First submitted
- 7 Jul 2022
- Start date
- 8 Dec 2022
- Primary completion date
- 2 Nov 2024
- Lead sponsor
- AbbVie
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05451316
What you commit to
- Study type: Observational
- Participants enrolled: 1
- From 8 Dec 2022 to the primary completion date, 2 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with UPA
Other illness
- Chronic pruritus resulting from another condition (e.g., neuropathic disorders) than AD, prurigo nodularis (PN)
- PN caused by medication, metal allergy, infection, insect bite
Other
- Contraindications to UPA
- Current participation in interventional research
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tohoku Medical and Pharmaceuti /ID# 252486 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.