Nucala Subcutaneous Injection Special Drug Use Investigation (Long-Term) (204524)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38541
• EU PAS number:
  EUPAS17926
• Study ID:
  38541
• Official title and acronym:
  Nucala Subcutaneous Injection Special Drug Use Investigation (Long-Term) (204524)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This investigation is conducted to collect and evaluate information on safety and effectiveness of long term use of Nucala subcutaneous injection in Asthma patients in daily clinical practice.
• Study status:
  Finalised

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 15/04/2016

Actual: 15/04/2016

Study start date

Planned: 31/01/2018

Actual: 11/01/2017

Date of final study report

Planned: 27/06/2024

Actual: 14/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-204524-protocol-redact

Regulatory

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