Lebrikizumab Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS) MotherToBaby Pregnancy Registry (J2T-MC-B005)

Study identification

• EU PAS number:
  EUPAS1000000608
• Study ID:
  1000000608
• Official title and acronym:
  Lebrikizumab Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS) MotherToBaby Pregnancy Registry (J2T-MC-B005)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Organization of Teratology Information Specialists (OTIS)

Study timelines

Date when funding contract was signed

Actual:12/05/2025

Study start date

Planned:01/12/2025

Actual:01/12/2025

Date of final study report

Planned:30/06/2036

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable