A Prospective Non-Interventional Study of Palforzia® in Children Aged 4-17 with Confirmed Peanut Allergy (AIMT-PAS-001)

Study identification

• EU PAS number:
  EUPAS44821
• Study ID:
  44822
• Official title and acronym:
  A Prospective Non-Interventional Study of Palforzia® in Children Aged 4-17 with Confirmed Peanut Allergy (AIMT-PAS-001)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Peanut allergy is a common and serious condition that often affects children, and can be associated with severe reactions, including life-threatening anaphylaxis. AR101 (Palforzia®) was developed to address the need for a regulated therapy that can induce and maintain a state of desensitization to peanut protein. The results of previous clinical studies showed that desensitization to peanut protein with Palforzia® provides a clinically meaningful level of desensitization sufficient to reduce the incidence and severity of allergic reactions, including anaphylaxis, because of accidental exposure to peanut protein. This observational study is being conducted to collect data on safety, health related quality of life (HRQoL), and health resource utilization (HRU) in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy treated with Palforzia® over a 24-month period in a real-world setting in Germany.
• Study status:
  Discontinued

Research institutions and networks

Institutions

Universitäts AllergieCentrum (UAC)

Study timelines

Date when funding contract was signed

Planned:12/01/2022

Study start date

Planned:19/01/2022

Actual:01/02/2022

Data analysis start date

Planned:12/10/2022

Date of interim report, if expected

Planned:12/10/2022

Date of final study report

Planned:30/04/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Marketing Authorization was transferred from Aimmune Therapeutics to Stallergenes

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable