Prospective, multi-centre, non-interventional safety study to collect real-world data on the safety of immunotherapy with Depigoid® Katze in patients with allergic rhinitis/rhino-conjunctivitis with or without controlled asthma due to feline epithelia (LETI MIAU-KAT 2022)

Study identification

• EU PAS number:
  EUPAS46091
• Study ID:
  50362
• Official title and acronym:
  Prospective, multi-centre, non-interventional safety study to collect real-world data on the safety of immunotherapy with Depigoid® Katze in patients with allergic rhinitis/rhino-conjunctivitis with or without controlled asthma due to feline epithelia (LETI MIAU-KAT 2022)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Prospective, multi-center, non-interventional safety study collecting real-world data on the safety of immunotherapy with Depigoid® Katze in patients with allergic rhinitis/rhino-conjunctivitis with or without controlled asthma due to feline epithelia. ; The total study duration is about 1.5 years. ; The duration of the observation of individual patients is 2-3 months. Depending on the dosing regimen, 3 or 5 visits per patient are scheduled. ; Approx. 80 centers in Germany with approx. 300 adults and 100 adolescent patients aged ≥ 12 years suffering from persistent moderate to severe allergic rhinitis and/or rhino-conjunctivitis with or without controlled asthma caused by clinically relevant sensitization to cats, demonstrated by a positive skin prick test (wheal diameter ≥ 3 mm) for Felix domesticus animal epithelia. ; The decision on the administration of a subcutaneous immunotherapy with Depigoid® Katze had been made based on patients’ symptoms/history prior to study inclusion. ; The patients have understood and signed the patient information and declaration of consent. Concomitant asthma must be controlled and stable in accordance with the SmPC. Patients are recruited from the patient pool of the participating centers. ; Primary variables and targets: ; - Number and severity of systemic reactions (WAO criteria) ; - Number and severity of local reactions; - Onset of systemic and/or local reaction (immediate or late phase) ; Secondary variables and targets: ; -Comparison of two up-dosing regimens (Conventional vs. Quick up-dosing) with regard to the primary variables ; -Comparison of two up-dosing regimens in terms of the proportion of patients reaching the maintenance treatment phase ; -Comparison of two up-dosing regimens with regard to the proportion of patients with local or systemic reactions ; -Development of the quality of life determined with the SF-12 questionnaire
• Study status:
  Finalised

Research institutions and networks

Institutions

ClinCompetence Cologne

Study timelines

Date when funding contract was signed

Planned: 23/06/2021

Actual: 23/06/2022

Study start date

Planned: 14/02/2022

Actual: 03/05/2022

Date of final study report

Planned: 01/04/2025

Actual: 31/03/2025

Sources of funding

Other

More details on funding

LETI Pharma GmbH

Regulatory

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