Dermatitis, AtopicNCT05391061
A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis
An observational study of Dermatitis, Atopic, run by Pfizer at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Abrocitinib
- Type of treatment
- Pill or oral medicine
- How many people
- 1,100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2023to 22 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
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- Severe hepatic impairment
- Pregnancy and breast-feeding
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Post Marketing Surveillance (PMS) Study for Cibinqo Tablet (Abrocitinib) in Patients With Moderate to Severe Atopic Dermatitis (AD) in Korea
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.
Read more
This study is seeking participants who:
- Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo
- 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.
Read the detailed description
This study is a single country, multicenter, prospective, non-interventional, observational post marketing surveillance study to evaluate the safety and effectiveness of Cibinqo® Tablet in participants with moderate to severe AD in routine clinical practice in Korea.
The purpose of this study is to evaluate the safety and effectiveness of Cibinqo® Tablet in routine clinical practice for approved indications in Korea.
The study population for this study is participants 12 years of age and older who have been diagnosed with moderate to severe AD and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.
About 3000 participants will be enrolled in several centers in this study. Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study.
Each investigator will sequentially enroll all subjects to whom Cibinqo is prescribed for the first time according to the "Dosage and Administration" of the approved labeling and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.
There is no mandatory fixed visit schedule. The investigator will collect patient data and record the information on each patient's case report form (CRF).
- Conditions
- Dermatitis, Atopic
- Being tested
- Abrocitinib
- Keywords
- Atopic Dermatitis, Abrocitinib, Cibinqo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
Also called Cibinqo
Tablets
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AE's) according to frequency
Measured: Up to 52 weeks from the time of first treatment
Number of participants with Adverse Drug Reactions (ADR's) according to frequency
Measured: up to 52 weeks from the time of first treatment
Number of participants with unexpected AE's according to frequency
Measured: up to 52 weeks from the time of first treatment
Number of participants with unexpected ADR's according to frequency
Measured: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Events (SAE's) according to frequency
Measured: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency
Measured: up to 52 weeks from the time of first treatment
Number of participants with Adverse Events of Special Interest (AESI) according to frequency
Measured: 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
Measured: 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
Measured: 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
Measured: At week 12 and 52 weeks after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start7 Jan 2023
- Primary completion22 Nov 2027 (estimated)
- Study completion22 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391061
- Sponsor's protocol ID
- B7451074
- Status last verified
- Dec 2025
- First submitted
- 19 May 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance (PMS) Study for Cibinqo Tablet (Abrocitinib) in Patients With Moderate to Severe Atopic Dermatitis (AD) in Korea
- ClinicalTrials.gov ID
- NCT05391061
- Acronym / sponsor ID
- B7451074
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic Dermatitis, Abrocitinib, Cibinqo
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 22 Nov 2027 (estimated)
- Study completion
- 22 Nov 2027 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo
- 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.
Detailed description
This study is a single country, multicenter, prospective, non-interventional, observational post marketing surveillance study to evaluate the safety and effectiveness of Cibinqo® Tablet in participants with moderate to severe AD in routine clinical practice in Korea.
The purpose of this study is to evaluate the safety and effectiveness of Cibinqo® Tablet in routine clinical practice for approved indications in Korea.
The study population for this study is participants 12 years of age and older who have been diagnosed with moderate to severe AD and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.
About 3000 participants will be enrolled in several centers in this study. Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study.
Each investigator will sequentially enroll all subjects to whom Cibinqo is prescribed for the first time according to the "Dosage and Administration" of the approved labeling and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.
There is no mandatory fixed visit schedule. The investigator will collect patient data and record the information on each patient's case report form (CRF).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbrocitinibAlso: CibinqoTablets | Drug | – |
Primary outcome
Number of participants with Adverse Events (AE's) according to frequency
Time frame: Up to 52 weeks from the time of first treatment
Number of participants with Adverse Drug Reactions (ADR's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with unexpected AE's according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with unexpected ADR's according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Events (SAE's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Adverse Events of Special Interest (AESI) according to frequency
Time frame: up to 52 weeks from the time of first treatment
3 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: At week 12 and 52 weeks after the first treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AE's) according to frequency (time frame: Up to 52 weeks from the time of first treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.