Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT05391061
Brief Summary:
The purpose of this non-interventional study is to learn about the safety and effectivness of Cibinqo Tablet for the possible treatment of atopic dermatitis (AD).
AD is a long-lasting itchy red rash, caused by a skin reaction.
This study is seeking participants who:
1. Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo
2. Have evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s) or legal guardian, have been informed of all important details of the study Investigators will collect and record the information on each participant's experiences with Cibinqo. This study medicine is a tablet which is taken by mouth. Participants will be observed for about a year. During this time, we will study the experiences of people receiving the study medicine to help us decide if the study medicine is safe and effective.
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:
NCT05391061
Study Brief:
Protocol Section:
NCT05391061