A Korea Post-marketing Surveillance to Learn About the Study Medicine, Abrocitinib (Cibinqo® Tablets) in People With Atopic Dermatitis

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05391061

Collaborator

(none)

3,000

Enrollment

61.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this PMS study is to identify problems or questions related to Cibinqo® Tablet after marketing in patients with atopic dermatitis in Korea under general clinical practice conditions. Through this study, safety of the Cibinqo® Tablet and how well they work in participants with AD, will be observed.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic	Drug: Abrocitinib

Detailed Description

This study is a single country, multicenter, prospective, non-interventional, observational post marketing surveillance study to evaluate the safety and effectiveness of Cibinqo® Tablet in participants with moderate to severe AD in routine clinical practice in Korea.

The purpose of this study is to evaluate the safety and effectiveness of Cibinqo® Tablet in routine clinical practice for approved indications in Korea.

The study population for this study is participants 12 years of age and older who have been diagnosed with moderate to severe AD and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.

About 3000 participants will be enrolled in several centers in this study. Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study.

Each investigator will sequentially enroll all subjects to whom Cibinqo is prescribed for the first time according to the "Dosage and Administration" of the approved labeling and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.

There is no mandatory fixed visit schedule. The investigator will collect patient data and record the information on each patient's case report form (CRF).

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Post Marketing Surveillance (PMS) Study for Abrocitinib in Patients With Moderate to Severe Atopic Dermatitis (AD) in Korea

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Nov 22, 2027

Anticipated Study Completion Date :

Nov 22, 2027

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse Events (AE's) according to frequency [Up to 52 weeks from the time of first treatment]
Number of participants with Adverse Drug Reactions (ADR's) according to frequency [up to 52 weeks from the time of first treatment]
Number of participants with unexpected AE's according to frequency [up to 52 weeks from the time of first treatment]
Number of participants with unexpected ADR's according to frequency [up to 52 weeks from the time of first treatment]
Number of participants with Serious Adverse Events (SAE's) according to frequency [up to 52 weeks from the time of first treatment]
Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency [up to 52 weeks from the time of first treatment]
Number of participants with Adverse Events of Special Interest (AESI) according to frequency [up to 52 weeks from the time of first treatment]

Secondary Outcome Measures

Proportion participants with change from Baseline in Participant-Rated Pruritus Score [At 12 weeks, and 15 weeks after the first treatment]
Proportion of patients achieving at least 4 points improvement in the severity of pruritus numerical rating scale (NRS) from baseline
Proportion of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline [At week 12 and 52 weeks after first treatment]
Proportion of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) [At week 12 and 52 weeks after first treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

This study is seeking participants who should meet the usual prescribing criteria for Cibinqo® Tablets as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.

Inclusion Criteria:

Patients with moderate to severe AD who have been determined to start treatment with Cibinqo Tablet according to the approved indications of the medicinal product
Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study

Exclusion Criteria:

Patients who have previously received Cibinqo Tablet
Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products
Patients who have contraindications to Cibinqo Tablet as specified in the approved LPD