Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy

  • STATUS
    Recruiting
  • End date
    Jul 9, 2026
  • participants needed
    300
  • sponsor
    Regeneron Pharmaceuticals
Updated on 18 February 2022
asthma
dupilumab
Accepts healthy volunteers

Summary

The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women.

The primary outcome of the study is major structural defects, and the secondary outcomes of the study are spontaneous abortion/miscarriage, stillbirth, elective termination/abortion, premature delivery, small for gestational age, pattern of 3 or more minor structural defects, postnatal growth of live born children to 1 year of age, postnatal serious or opportunistic infections in live born children to 1 year of age, and hospitalizations in live children up to 1 year of age.

Details
Condition Atopic Dermatitis (AD), Asthma
Treatment Dupilumab
Clinical Study IdentifierNCT04173442
SponsorRegeneron Pharmaceuticals
Last Modified on18 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort 1: Dupilumab-Exposed Cohort
Pregnant women
Exposure to dupilumab for the treatment of the approved indications of atopic dermatitis (AD) or asthma, for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy
Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
Pregnant women
Diagnosed with a dupilumab-approved indications of moderate-to-severe AD without asthma or moderate-to-severe asthma; frequency matched to the exposed group by disease indication, with the indication and severity validated by medical records when possible
No exposure to dupilumab any time in the current pregnancy or within 10 weeks of the first day of the LMP and may or may not have taken another medication for their disease in the current pregnancy
Cohort 3: Healthy Comparison Cohort (Comparison Group 2)
Pregnant women

Exclusion Criteria

Cohort 1: Dupilumab-Exposed Cohort
Women who have first contact with the project after prenatal diagnosis of any major structural defect
Women who have used dupilumab for an indication other than asthma or AD
Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
Women who have first contact with the project after prenatal diagnosis of any major structural defect
Exposure to dupilumab within 10 weeks of LMP or anytime during the current pregnancy
Cohort 3: Non-Diseased Comparison Cohort (Comparison Group 2)
Exposure to dupilumab within 10 weeks prior to the first day of the LMP
Women who have a diagnosis of any dupilumab approved indication
Women who have first contact with the project after prenatal diagnosis of any major structural defect
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note