Pregnancy and Infant Outcomes in Patients Exposed to Nemolizumab During Pregnancy: A Retrospective Observational Study Based on Healthcare Databases (RD.06.SPR.207424)

Study identification

• EU PAS number:
  EUPAS1000000945
• Study ID:
  1000000945
• Official title and acronym:
  Pregnancy and Infant Outcomes in Patients Exposed to Nemolizumab During Pregnancy: A Retrospective Observational Study Based on Healthcare Databases (RD.06.SPR.207424)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This will be an observational cohort study that will use multiple existing databases to assess pregnancy and infant outcomes among patients with moderate to severe AD or PN. This study will assess pregnancy and infant outcomes among pregnancies from patients within 3 cohorts:; (1) Nemolizumab Cohort: pregnancies among patients with moderate to severe AD or PN exposed to nemolizumab during pregnancy;; (2) Other AD/PN Treatment Cohort: pregnancies among patients with moderate to severe AD or PN exposed to other AD or PN treatments, including monoclonal antibodies other than nemolizumab, during pregnancy; and; (3) Unexposed Cohort: pregnancies among patients with moderate to severe AD or PN who are not exposed to nemolizumab or any of the comparator AD or PN treatments during pregnancy.
• Study status:
  Planned

Research institutions and networks

Institutions

Optum

Germany

Study timelines

Date when funding contract was signed

Actual:10/03/2025

Study start date

Planned:08/12/2032

Date of final study report

Planned:03/05/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Galderma

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

RD.06.SPR.207424