An Observational Study to Assess the Utilisation and Safety of Ixekizumab Among Pediatric Patients Treated in the Course of Routine Clinical Care (I1F-MC-B015)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36307
• EU PAS number:
  EUPAS36306
• Study ID:
  36307
• Official title and acronym:
  An Observational Study to Assess the Utilisation and Safety of Ixekizumab Among Pediatric Patients Treated in the Course of Routine Clinical Care (I1F-MC-B015)
• 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

Planned: 31/07/2020

Actual: 25/08/2020

Study start date

Planned: 31/08/2021

Date of final study report

Planned: 30/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly & Co.

Study protocol

Initial protocol

I1F-MC-B015 PASS Protocol v1.0_Redacted

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)