Safety of Abrocitinib in Pregnant Women and Their Babies
CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
This study is testing whether the medication abrocitinib is safe for pregnant women and their babies compared to women with similar skin conditions who haven't taken the drug.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 0 Years and up |
| Sex | Female |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | abrocitinib |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05721937 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of abrocitinib (CIBINQO) in pregnant women and their offspring. It will compare two groups: pregnant women who have received abrocitinib during pregnancy and those with moderate-to-severe atopic dermatitis who have not been exposed to the drug. Participants will be monitored until their infants reach 12 months of age to gather data on any potential safety concerns. The study will help determine the implications of using abrocitinib during pregnancy.
Who should consider this trial
Good fit: Ideal candidates include women who are currently or recently pregnant and have either received abrocitinib or have a diagnosis of moderate-to-severe atopic dermatitis.
Not a fit: Patients who are not pregnant or have not been diagnosed with moderate-to-severe atopic dermatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical information on the safety of abrocitinib for pregnant women and their children.
How similar studies have performed: While there may be studies on the safety of medications during pregnancy, this specific investigation into abrocitinib is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.
Where this trial is running
New York, New York
- Pfizer — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.