Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43838
• EU PAS number:
  EUPAS43837
• Study ID:
  43838
• Official title and acronym:
  Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Regeneron Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual: 27/03/2018

Study start date

Actual: 30/09/2019

Data analysis start date

Planned: 21/01/2027

Date of final study report

Planned: 26/02/2027

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Regeneron Pharmaceuticals,Inc., Sanofi

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

R668-AD-1760,NCT03936335