Alofisel-4001: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44182
• EU PAS number:
  EUPAS31439
• Study ID:
  44182
• Official title and acronym:
  Alofisel-4001: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  France

  Germany

  Israel

  Spain
• Study description:
  The main aim is to check the long-term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn’s disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. An magnetic resonance imaging (MRI) will be performed several times during the study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 22/05/2019

Study start date

Planned: 15/01/2021

Actual: 22/12/2020

Data analysis start date

Planned: 22/05/2025

Date of final study report

Planned: 30/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

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)