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NCT03936335 · ClinicalTrials.gov registry record
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
A clinical trial of Atopic Dermatitis and Adverse Pregnancy Outcomes, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- 3,930
- Enrollment target
- 1
- Study location
NCT03936335 is a study of Atopic Dermatitis and Adverse Pregnancy Outcomes that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 3,930 participants, above the 583-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (574% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03936335, a study of Atopic Dermatitis and Adverse Pregnancy Outcomes, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- 3,930 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.
Conditions Studied
Interventions
- DRUG dupilumab
Study Locations (1)
Massachusetts
- Regeneron Research Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,930 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2027-01-21 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03936335
The ClinicalTrials.gov registry entry for NCT03936335 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 3,930 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 583-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (574% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which dupilumab is the first listed.
NCT03936335 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03936335 about?
NCT03936335 is a clinical study titled "An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)". The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated wi...
What is the current status of trial NCT03936335?
This trial is currently recruiting. The enrollment target is 3,930 participants. The study started on 2019-09-30. Estimated completion is 2027-01-21.
What conditions does trial NCT03936335 study?
This clinical trial studies the following conditions: Atopic Dermatitis, Adverse Pregnancy Outcomes.
What interventions are being tested in trial NCT03936335?
The interventions under investigation include: dupilumab (DRUG).
Who is sponsoring clinical trial NCT03936335?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03936335 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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