A Study to Learn About the Study Medicine (CIBINQO) in People With Atopic Dermatitis.

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: CIBINQO

• Registration Number: NCT05387980
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about the safety and effectiveness (how well the study treatment works) of the study medicine (CIBINQO) for the potential treatment of atopic dermatitis in people under Japanese medical practice.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2022-04-19
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Participants receiving this Product for treatment of AD.
2. Participants start receiving this Product (commercial product) for the first time and no earlier than the contract date of this Study, or Participants who continues to receive this drug after hospital transfer can be registered retrospectively.

Read More

Exclusion Criteria

1. Participants previously enrolled in this Study at the same site.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving CIBINQO	CIBINQO	Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.

Primary Outcome Measures

Name	Time	Method
Number of Participants with adverse drug reactions	156 weeks
Number of Participants with Discontinuation of Treatment	156 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Change From Baseline in Pruritus Assessment	Baseline, 156 weeks
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score	Baseline, 156 weeks	IGA Scores: Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( \>=2) Points at Week X: Non-responder Imputation
Percentage of Participants with Change From Baseline in Eczema Area and Severity Index (EASI)	Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Affected % Body Surface Area (BSA)	Baseline, 156 weeks

Trial Locations

Locations (1)

Pfizer Local Country Office; 🇯🇵 Tokyo, Japan