A Study to Learn About the Study Medicine (CIBINQO) in Pe... | NCT05387980

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

NCT05387980

Sponsor

Pfizer

Status

Active, not recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

1,128Actual

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

CIBINQO

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2022Actual

Primary Completion Date

Nov 1, 2028Estimated

Completion Date

Nov 1, 2028Estimated

First Submitted Date

May 9, 2022

First Submission Date that Met QC Criteria

May 19, 2022

First Posted Date

May 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving CIBINQO		Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.	Drug: CIBINQO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CIBINQO	Drug	Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.	Patients receiving CIBINQO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adolescent participants diagnosed with atopic dermatitis in Japan.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Local Country Office		Tokyo			Japan

References Module

Citations

Not provided

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis