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Prospective, multi-centre, non-interventional safety trial 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

开始日期2022-05-03

申办/合作机构

LETI Pharma GmbH

NCT03850626 / CompletedN/A

Validierung Des cSMS in Patienten Mit Allergischer Rhinokonjunktivitis (Baum- Und Gräserpollen, Hausstaubmilben). - Eine NIS Bei Patienten, Die Depigoid® Als Spezifische Immuntherapie Erhalten

The CSMS was defined by the European Academy of Allergy and Immunology Taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (AIT). The aim of this study is to validate the CSMS as a tool to assess the clinical effects of Depigoid AIT, so that the CSMS can be used in future studies as a primary endpoint as well as a comparative parameter.

开始日期2018-09-09

申办/合作机构

LETI Pharma GmbH

EUCTR2014-004732-19-DE / Not yet recruiting临床2期

A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum versus Placebo in Patients with Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent Asthma

开始日期2015-07-20

申办/合作机构

LETI Pharma GmbH

100 项与 LETI Pharma GmbH 相关的临床结果

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0 项与 LETI Pharma GmbH 相关的专利（医药）

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7

项与 LETI Pharma GmbH 相关的文献（医药）

2024-04-12·Journal of Investigational Allergology and Clinical Immunology

English

Article

作者: Carbajo Martínez, E ; Lozano Andaluz, S V ; Cubero Saldaña, J L ; Villalba Díaz, M T ; Martínez-Lostao, L ; Colás Sanz, C ; Salamanca Fernández, G ; Ferrer Clavería, L ; Agulló-García, A

2022-05-01·Molecular Immunology3区 · 医学

Immunological mechanisms involved in the human response to a dog dander allergoid

3区 · 医学

Article

作者: Calzada, D ; Mayorga, C ; Pascal, M ; Odena, M A ; Salas, M ; Oliveira, E ; Carnés, J ; Álvarez, J ; Balsa, D ; Aranda, T ; Escutia, M R ; M Gallego, G

BACKGROUNDDog allergens are a common cause of allergic sensitisation and trigger respiratory symptoms worldwide. However, clinical evidence regarding dog immunotherapy is limited. Therefore, the aim of this study was to analyse the immunomodulatory properties of a new allergoid from dog dander, thereby deepening the understanding of the molecular mechanisms involved in the reestablishment of the tolerogenic response.METHODSThree independent batches of dog dander native and allergoid allergen extracts were manufactured and characterised. Allergenic profiles were analysed by the identification of all dog allergens and quantification of the major allergens Can f 1 and Can f 5. The allergenicity profile of the allergoid was studied using biological potency and basophil activation tests. In vitro immunomodulatory parameters was evaluated as the capacity of the allergoid to induce IgG antibodies that block IgE binding to the allergen and cytokine promotion (IFN-γ, IL-4, IL-6, IL-10, IL-13, and TNF-α) in PBMCs from allergic donors.RESULTSThe presence of all dog allergens, including Can f 1 and Can f 5, was confirmed in both types of extracts. The new allergoid showed a low IgE binding capacity, which significantly affected the activation of effector cells, such as basophils. The IgG antibodies induced by the allergoid in rabbits blocked human IgE binding epitopes on the dog native extract and induced Th1 and Treg responses by increasing IFN-γ and IL-10 levels in PBMCs from allergic donors.CONCLUSIONThis new dog dander allergoid containing Can f 1 and Can f 5 showed a low capacity to bind IgE and to activate basophils in dog allergic patients. Furthermore, it showed potent activation of Th1 mediators and induction of tolerance through Treg activation. This allergoid could offer a safer profile than the native extract and could be an effective immunotherapy treatment for dog allergic patients.

2017-06-01·Immunity, Inflammation and Disease4区 · 医学

AIT to HDM: A non-interventional study report

4区 · 医学

ArticleOA

作者: Zimmermann, Jürgen ; Klein, Christian ; Mahler, Vera ; Sager, Angelika

INTRODUCTIONHouse dust mite (HDM) allergens are major causes for the development of allergic diseases. A disease modifying effect and clinical benefit of allergen immunotherapy (AIT) has been demonstrated in a number of clinical trials. Clinical trials, however, are carried out in selected populations under specific conditions based on inclusion and exclusion criteria and may not represent the entire patient population from medical practice. Objective of this study conducted in patients with HDM allergy was to systematically collect information about the benefit of AIT under clinical routine conditions.METHODSIn this prospective, multi-center non-interventional study, 220 patients (117 adults, 103 children) with HDM allergy receiving subcutaneous AIT with Depigoid^® were monitored for 2 years. Organ-specific key symptoms, health-related quality of life (QoL), and the use of concomitant anti-allergic medication were assessed at baseline and after 12 and 24 months. Effectiveness and tolerability of the AIT was assessed by physicians and patients. Occurrence of adverse events (AEs) was continuously monitored.RESULTSTwo hundred and nineteen patients (116 adults, 103 children) were evaluated. A major improvement of the total symptom-score was observed after 24 (12) months in 76% (72%) and 80% (79%) of adults and children, respectively, accompanied by a reduction in concomitant anti-allergic medication and a pronounced improvement in QoL. The effectiveness and tolerability of the AIT was estimated as very good/good by 80-90% of physicians and patients. AEs were observed in 4/117 adults (3.4%) and in 7/103 children (6.8%). Serious AEs were reported in three adults and one child: A grade-II anaphylactic reaction (one adult) controlled by oral antihistamines (no hospitalization) classified as "definitely," three others as not (2) or possibly (1) drug-related.CONCLUSIONSThe data collected from 220 patients confirm the efficacy, tolerability/safety, and acceptance of AIT with Depigoid^® in adults and children with HDM allergy under routine clinical conditions.

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药物(靶点)	适应症	全球最高研发状态

Birch pollen allergy immunotherapy(LETI Pharma GmbH)	特应性皮炎更多	临床3期
Grass pollen allergy immunotherapy(Laboratorios LETI SL)	鼻结膜炎更多	无进展