A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Japan
Tohoku Medical and Pharmaceuti /ID# 252486
RECRUITING
Sendai
Contact Information
Primary
AbbVie GK Clinical Trial Registration Desk
abbvie_jpn_info_clingov@abbvie.com
+81-3-4577-1111
Time Frame
Start Date: 2022-12-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200
Treatments
Upadacitinib
Adolescents and adults with moderate to severe prurigo-type AD, who are prescribed UPA according to the label and practice in Japan.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov