A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring (NCT05721937)
CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Pfizer — New York, New York
Age range: 0 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Pfizer — New York, New York
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atopic Dermatitis
- A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden — Birmingham, Alabama
- ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis — Phoenix, Arizona
- A Study of Barzolvolimab in Patients With Atopic Dermatitis — Birmingham, Alabama
- Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis — Chicago, Illinois
- A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis — Birmingham, Alabama
- A Study Evaluating APG777 in Atopic Dermatitis — Fountain Valley, California
Explore by condition: All Atopic Dermatitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.