Atopic DermatitisNCT05721937
A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
An observational study of Atopic Dermatitis, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring. The study is seeking participants who: Are currently or recently pregnant Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of… Read more about this study
- Who is it for?
- Ages 0 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Abrocitinib
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 31 Dec 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 0 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include pregnant women of any age who meet the eligibility criteria for inclusion. The exposed cohort will include women who are exposed to CIBINQO at any time during pregnancy. All pregnant women exposed to CIBINQO will be eligible to participate in the registry, but the analysis population will be limited to women with moderate-to-severe AD. The primary comparator group will include women with moderate to- severe AD who are unexposed to CIBINQO during pregnancy.
Who may be able to join
- Women of any age who are currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
- Consent to participate in this study and evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- Authorization for her healthcare provider(s) to provide data to the registry
- Must receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception) OR have a diagnosis of moderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.
Who cannot join
- Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pfizer
New York, New York, 10001
About this study
Official title: CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring.
The study is seeking participants who:
Read more
- Are currently or recently pregnant
- Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis
All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy.
The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy.
Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.
- Conditions
- Atopic Dermatitis
- Being tested
- Abrocitinib
- Keywords
- pregnancy, dermatitis, atopic
- 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
taken by mouth
| Study group | Role | What they receive |
|---|---|---|
| Exposed to CIBINQO during pregnancy | Received at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception). Receives: Drug: Abrocitinib | |
| Unexposed to CIBINQO during pregnancy | Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of live birth children with major congenital malformations
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
Measured: Enrollment until 12 months after delivery
Secondary outcomes (8)
Percent of participants with children with minor congenital malformations
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Measured: Enrollment until 12 months after delivery
Percent of participants with spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.
Measured: Enrollment until end of pregnancy (up to 20 gestational weeks)
Percent of participants with stillbirths
An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
Measured: Enrollment until end of pregnancy (up to 9 months)
Percentage of participants with an elective termination
A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to fetal abnormalities
Measured: Enrollment until end of pregnancy (up to 9 months)
Percent of participants with preterm birth
A live birth occurring at <37 gestational weeks.
Measured: Enrollment until 12 months after delivery
Percent of participants with children born small for gestational age
Birthweight <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Measured: Enrollment until 12 months after delivery
Percentage of participants with children with postnatal growth deficiency
Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts
Measured: Enrollment until 12 months after delivery
Percent of participants with infant developmental delay
Failure to achieve the developmental milestones for chronological age, as defined by the CDC.
Measured: Enrollment until 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start25 Jul 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721937
- Sponsor's protocol ID
- B7451095
- Other IDs
- NCT05721937
- Status last verified
- Dec 2025
- First submitted
- 26 Jan 2023
- 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
- CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT05721937
- Acronym / sponsor ID
- B7451095
- Conditions
- Atopic Dermatitis
- Keywords
- pregnancy, dermatitis, atopic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 2023 (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 observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring.
The study is seeking participants who:
- Are currently or recently pregnant
- Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis
All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy.
The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy.
Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to CIBINQO during pregnancy | – | Drug: AbrocitinibReceived at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception). |
| Unexposed to CIBINQO during pregnancy | – | –Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy. |
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant women of any age who meet the eligibility criteria for inclusion. The exposed cohort will include women who are exposed to CIBINQO at any time during pregnancy. All pregnant women exposed to CIBINQO will be eligible to participate in the registry, but the analysis population will be limited to women with moderate-to-severe AD. The primary comparator group will include women with moderate to- severe AD who are unexposed to CIBINQO during pregnancy.
Key inclusion criteria (4 listed)
- Women of any age who are currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
- Consent to participate in this study and evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- Authorization for her healthcare provider(s) to provide data to the registry
- Must receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception) OR have a diagnosis of moderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.
Key exclusion criteria (1 listed)
- Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.
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 |
|---|---|---|
| Abrocitinibtaken by mouth | Drug | Exposed to CIBINQO during pregnancy |
Primary outcome
Percent of live birth children with major congenital malformations
Time frame: Enrollment until 12 months after delivery
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
8 secondary outcomes
Percent of participants with children with minor congenital malformations
Time frame: Enrollment until 12 months after delivery
Percent of participants with spontaneous abortion
Time frame: Enrollment until end of pregnancy (up to 20 gestational weeks)
Percent of participants with stillbirths
Time frame: Enrollment until end of pregnancy (up to 9 months)
Percentage of participants with an elective termination
Time frame: Enrollment until end of pregnancy (up to 9 months)
Percent of participants with preterm birth
Time frame: Enrollment until 12 months after delivery
Percent of participants with children born small for gestational age
Time frame: Enrollment until 12 months after delivery
Percentage of participants with children with postnatal growth deficiency
Time frame: Enrollment until 12 months after delivery
Percent of participants with infant developmental delay
Time frame: Enrollment until 12 months after delivery
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 Atopic Dermatitis, run by Pfizer at 1 site in United States.
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 4 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: 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 United States. 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?
Percent of live birth children with major congenital malformations (time frame: Enrollment until 12 months after delivery). 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.