Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Ixekizumab (I1F-MC-B005)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28013
• EU PAS number:
  EUPAS15481
• Study ID:
  28013
• Official title and acronym:
  Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Ixekizumab (I1F-MC-B005)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Planned

Research institutions and networks

Institutions

HealthCore

Study timelines

Date when funding contract was signed

Actual: 09/02/2016

Study start date

Planned: 31/03/2018

Date of final study report

Planned: 30/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

ELI_Pregnancy_Safety_Protocol_Redacted

Updated protocol

B005 PASS(2)_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)