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

March 17, 2026 updated by: Pfizer

CIBINQO® TABLETS SPECIAL INVESTIGATION

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Pfizer Local Country Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adolescent participants diagnosed with atopic dermatitis in Japan.

Description

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients receiving CIBINQO
Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.
Drug: CIBINQO
Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with adverse drug reactions
Time Frame: 156 weeks
156 weeks
Number of Participants with Discontinuation of Treatment
Time Frame: 156 weeks
156 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score
Time Frame: 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
Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Eczema Area and Severity Index (EASI)
Time Frame: Baseline, 156 weeks
Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Affected % Body Surface Area (BSA)
Time Frame: Baseline, 156 weeks
Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Pruritus Assessment
Time Frame: Baseline, 156 weeks
Baseline, 156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7451055
  • NCT05387980 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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