A Study to Learn About the Study Medicine (CIBINQO) in People With Atopic Dermatitis.
CIBINQO® TABLETS SPECIAL INVESTIGATION
1 other identifier
observational
1,128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2022
CompletedFirst Submitted
Initial submission to the registry
May 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
March 19, 2026
March 1, 2026
6.5 years
May 9, 2022
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with adverse drug reactions
156 weeks
Number of Participants with Discontinuation of Treatment
156 weeks
Secondary Outcomes (4)
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score
Baseline, 156 weeks
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
Percentage of Participants with Change From Baseline in Pruritus Assessment
Baseline, 156 weeks
Study Arms (1)
Patients receiving CIBINQO
Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.
Interventions
Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.
Eligibility Criteria
Adolescent participants diagnosed with atopic dermatitis in Japan.
You may qualify if:
- Participants receiving this Product for treatment of AD.
- 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.
You may not qualify if:
- \. Participants previously enrolled in this Study at the same site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Local Country Office
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2022
First Posted
May 24, 2022
Study Start
April 19, 2022
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.