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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: Recruiting study of Atopic Dermatitis and Adverse Pregnancy Outcomes, sponsored by Regeneron Pharmaceuticals.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through December 2024

Interventions

  • DRUG dupilumab

Study Locations (1)

Massachusetts

  • Regeneron Research Site - Boston

Trial Details

FieldValue
Enrollment Target 3,930 participants
Start Date 2019-09-30
Est. Completion 2027-01-21
Regeneron Pharmaceuticals

280 total trials

What NCT03936335 shows while recruiting

NCT03936335 is an observational study that tracks outcomes without assigning an intervention. Its 3,930 participants enrollment target places it among the larger protocols in the corpus, above the 583-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (574% higher).

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 a single indexed study location in 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.

Similar trials for Atopic Dermatitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03936335's enrollment target sits among peer trials

3,930 5th of 150 higher than 146 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03936335, the US trial registry maintained by the National Library of Medicine. NCT03936335 (large enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.