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

NCT05451316 | Completed

• 1 other identifier: P23-433
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Prurigo Nodularis; Prurigo-type AD; Skin; Dermatology; Upadacitinib; ADMIRE; RINVOQ

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4.

  WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours in patients with moderate to severe AD, based on the following question: "On a scale 0 to 10, with 0 being 'no itch' and 10 being 'worst imaginable itch', how would you rate your itch at its worst during the past 24 hours?"

  Up to Week 12

Study Arms (1)

Upadacitinib

Adolescents and adults with moderate to severe prurigo-type AD, who are prescribed UPA according to the label and practice in Japan.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and adults, age ≥ 12 years, with a physician-confirmed diagnosis of atopic dermatitis (AD), who are prescribed UPA according to the label and practice in Japan. The decision to prescribe UPA will be made prior to and independent of study participation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Tohoku Medical and Pharmaceuti /ID# 252486

Sendai, Miyagi, 983-0005, Japan

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 11, 2022
• Study Start: December 8, 2022
• Primary Completion: November 2, 2024
• Study Completion: November 2, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

JP (1)