A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis

NCT05391061 | Recruiting

• 1 other identifier: B7451074
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this non-interventional study is to learn about the safety and effectivness of Cibinqo Tablet for the possible treatment of atopic dermatitis (AD). AD is a long-lasting itchy red rash, caused by a skin reaction. This study is seeking participants who:

1. 1.Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo
2. 2.Have evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s) or legal guardian, have been informed of all important details of the study Investigators will collect and record the information on each participant's experiences with Cibinqo. This study medicine is a tablet which is taken by mouth. Participants will be observed for about a year. During this time, we will study the experiences of people receiving the study medicine to help us decide if the study medicine is safe and effective.

Conditions

Dermatitis, Atopic

Keywords

Atopic Dermatitis, Abrocitinib, Cibinqo

Outcome Measures

Primary Outcomes (7)

• Number of participants with Adverse Events (AE's) according to frequency

  Up to 52 weeks from the time of first treatment

• Number of participants with Adverse Drug Reactions (ADR's) according to frequency

  up to 52 weeks from the time of first treatment

• Number of participants with unexpected AE's according to frequency

  up to 52 weeks from the time of first treatment

• Number of participants with unexpected ADR's according to frequency

  up to 52 weeks from the time of first treatment

• Number of participants with Serious Adverse Events (SAE's) according to frequency

  up to 52 weeks from the time of first treatment

• Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency

  up to 52 weeks from the time of first treatment

• Number of participants with Adverse Events of Special Interest (AESI) according to frequency

  up to 52 weeks from the time of first treatment

Secondary Outcomes (3)

• Proportion of participants achieving the Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >=2 points

  At 12 weeks, and 52 weeks after the first treatment

• Proportion of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline

  At week 12 and 52 weeks after the first treatment

• Proportion of Participants Achieving >=4 Points improvement in the severity of Pruritus Numerical Rating Scale (NRS) from baseline

  At week 12 and 52 weeks after the first treatment

Interventions

Abrocitinib DRUG

Tablets

Also known as: Cibinqo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for this study is patients 12 years of age and older who have been diagnosed with moderate to severe Atopic Dermatitis (AD) and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.

You may qualify if:

• Patients with moderate to severe AD who have been determined to start treatment with Cibinqo Tablet according to the approved indications of the medicinal product.
• Atopic Dermatitis Cibinqo Tablet is indicated for the treatment of patients 12 years of age and older with moderate-to-severe atopic dermatitis who have required systemic therapies.
• Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study

You may not qualify if:

• Patients who have previously received Cibinqo Tablet
• Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products
• Patients who have contraindications to Cibinqo Tablet as specified in the approved LPD • Contraindications to Cibinqo Tablet
• Patients with platelet count \<150 × 103/mm3, an absolute neutrophil count (ANC) \<1 × 103/mm3, an absolute lymphocyte count (ALC) \<0.5 × 103/mm3 or who have a haemoglobin value \<8 g/dL
• Hypersensitivity to the active substance or to any of the excipients
• Active serious systemic infetions, including tuberculosis(TB)
• Severe hepatic impairment
• Pregnancy and breast-feeding
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Tower

Seoul, 04631, South Korea

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Study Start: January 7, 2023
• Primary Completion (Estimated): November 22, 2027
• Study Completion (Estimated): November 22, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)