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Active, Not Recruiting

NCT Number: NCT05387980

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Local Country Office

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

CIBINQO

Drug

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

Primary outcomes

  1. Number of Participants with adverse drug reactions

    Time frame: 156 weeks

  2. Number of Participants with Discontinuation of Treatment

    Time frame: 156 weeks

Secondary outcomes

  1. 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

  2. Percentage of Participants with Change From Baseline in Eczema Area and Severity Index (EASI)

    Time frame: Baseline, 156 weeks

  3. Percentage of Participants with Change From Baseline in Affected % Body Surface Area (BSA)

    Time frame: Baseline, 156 weeks

  4. Percentage of Participants with Change From Baseline in Pruritus Assessment

    Time frame: Baseline, 156 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

CIBINQO® TABLETS SPECIAL INVESTIGATION

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 24, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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