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NCT05721937 · ClinicalTrials.gov registry record
A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
A clinical trial of Atopic Dermatitis, sponsored by Pfizer.
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT05721937: Recruiting study of Atopic Dermatitis, sponsored by Pfizer.
NCT05721937 is a study of Atopic Dermatitis that is actively recruiting participants, run by Pfizer. The registered enrollment target is 400 participants, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05721937, a study of Atopic Dermatitis, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Abrocitinib
Study Locations (1)
New York
- Pfizer - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-07-25 |
| Est. Completion | 2027-12-31 |
What NCT05721937 shows while recruiting
NCT05721937 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Abrocitinib is the first listed.
NCT05721937 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05721937 about?
NCT05721937 is a clinical study titled "A Study of How Safe Abrocitinib (CIBINQO) is 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: * Are currently or recently pregnant * Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy O...
What is the current status of trial NCT05721937?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2023-07-25. Estimated completion is 2027-12-31.
What conditions does trial NCT05721937 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT05721937?
The interventions under investigation include: Abrocitinib (DRUG).
Who is sponsoring clinical trial NCT05721937?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05721937 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05721937's enrollment target sits among peer trials
400 33rd of 150 higher than 117 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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