Atopic DermatitisNCT05387980
A Study to Learn About the Study Medicine (CIBINQO) in People With Atopic Dermatitis.
An observational study of Atopic Dermatitis, run by Pfizer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CIBINQO
- Type of treatment
- Pill or oral medicine
- How many people
- 1,128 participants
- Where
- 1 siteJapan
- Study dates
- 19 Apr 2022to 1 Nov 2028
- 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: Adolescent participants diagnosed with atopic dermatitis in Japan.
Who may be able to join
- 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.
Who cannot join
- 1. Participants previously enrolled in this Study at the same site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CIBINQO® TABLETS SPECIAL INVESTIGATION
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.
- Conditions
- Atopic Dermatitis
- Being tested
- CIBINQO
- Keywords
- JAK Inhibitor, Atopic Dermatitis (AD), Abrocitinib, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIBINQODrug
Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving CIBINQO | Patients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis. Receives: Drug: CIBINQO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with adverse drug reactions
Measured: 156 weeks
Number of Participants with Discontinuation of Treatment
Measured: 156 weeks
Secondary outcomes (4)
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
Measured: Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Eczema Area and Severity Index (EASI)
Measured: Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Affected % Body Surface Area (BSA)
Measured: Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Pruritus Assessment
Measured: Baseline, 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start19 Apr 2022
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,128 participants (actual)
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
- NCT05387980
- Sponsor's protocol ID
- B7451055
- Status last verified
- Mar 2026
- First submitted
- 9 May 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIBINQO® TABLETS SPECIAL INVESTIGATION
- ClinicalTrials.gov ID
- NCT05387980
- Acronym / sponsor ID
- B7451055
- Conditions
- Atopic Dermatitis
- Keywords
- JAK Inhibitor, Atopic Dermatitis (AD), Abrocitinib, Eczema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 24 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving CIBINQO | – | Drug: CIBINQOPatients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescent participants diagnosed with atopic dermatitis in Japan.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Participants previously enrolled in this Study at the same site.
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 |
|---|---|---|
| CIBINQOPatients receiving CIBINQO tablets by mouth for the treatment of Atopic Dermatitis. | Drug | Patients receiving CIBINQO |
Primary outcome
Number of Participants with adverse drug reactions
Time frame: 156 weeks
Number of Participants with Discontinuation of Treatment
Time frame: 156 weeks
4 secondary outcomes
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score
Time frame: Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Eczema Area and Severity Index (EASI)
Time frame: Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Affected % Body Surface Area (BSA)
Time frame: Baseline, 156 weeks
Percentage of Participants with Change From Baseline in Pruritus Assessment
Time frame: Baseline, 156 weeks
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 19 Mar 2026.
- 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.
Related trials for Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
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. This study is not recruiting at the moment.
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 Atopic Dermatitis, run by Pfizer at 1 site in Japan.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. 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 Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with adverse drug reactions (time frame: 156 weeks). The study lists 2 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 19 Mar 2026.