Clinical trial NCT05451316: 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
Official title: A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: Prurigo Nodularis
Prurigo-type AD
Skin
Dermatology
Upadacitinib
ADMIRE
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4.
timeFrame: Up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Sendai-shi
country: Japan
facility: Tohoku Medical and Pharmaceuti /ID# 252486
state: Miyagi
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: