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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05387980
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Atopic Dermatitis Drug: CIBINQO

Study Design
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation for CIBINQO （Long Term）
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adolescent participants diagnosed with atopic dermatitis in Japan.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05387980


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Japan
Pfizer Local Country Office Recruiting
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05387980    
Other Study ID Numbers: B7451055
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
JAK Inhibitor
Atopic Dermatitis (AD)
Abrocitinib
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases