Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from grass pollen allergy
- Conditions
- Patients with grass pollen-related allergic rhinitis/rhino-conjunctivitis (with well-controlled mild-to-moderate or without asthma)MedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855MedDRA version: 20.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870MedDRA version: 20.0Level: LLTClassification code 10001709Term: Allergic conjunctivitisSystem Organ Class: 100000004853MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-002881-42-DE
- Lead Sponsor
- ROXALL Medizin GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
•Patients who signed and dated the patients' informed consent form obtained prior to any study-specific examination.
•Female or male patients between 18 and 65 years of age, at the time of signing the informed consent form
•Patients with moderate-to-severe allergic rhinitis / rhino-conjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.
•Patients with or without well-controlled mild-to-moderate asthma according to GINA guidelines (Global Initiative for Asthma, 2022).
•Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
•Sensitization to Phleum pratense, verified by:
a)positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and positive (histamine) control = 3 mm) and,
b)serum allergen-specific IgE to Phleum pratense = 0.7 kU/L (CAP EAST class = 2) and,
c) positive response to nasal provocation with Phleum pratense allergen extract (at least at the fourth concentration step)
•Assumed compliance and ability of the patient to understand the patient´s electronic diary and to follow the instructions of the study staff
•Safety laboratory results within the normal range or considered to be not clinically significant in any other case
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
• Previous immunotherapy with grass pollen allergen extract according to the homologous
group of grass pollen of the Poaceae group”, as defined in Annex 1 in the Guideline on
allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within
the last 5 years
• Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen ,
which interfere with the conduct of the study (e. g. with the tNPT), especially if the result
in SPT for this allergen is higher than that for Phleum pratense
• Patients with co-sensitizations to any pollen or mould with overlapping seasons but
which are not cross-reactive with Phleum pratense and with specific IgE levels = class
2 CAP/PHADIA (unless the relevance can be excluded by component resolved
diagnosis)
• Simultaneous participation in other clinical trials
• Simultaneous specific immunotherapy with other allergens
• Participation in a clinical trial in the last three months before enrolment
• Asthmatic patients with forced expiratory volume (FEV1) = 70 % of predicted normal
value
• Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative
for Asthma, 2022)
• Severe acute or chronic inflammatory or infectious diseases
• Diseases of the immune system such as autoimmune and immune deficiencies (with
exception to well controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
• Chronic or acute diseases of the heart, kidney or liver with severe impairment of their
function
• Hypersensitivity to excipients of the IMP
• Any severe or unstable lung disease (e. g. active tuberculosis, cystic fibrosis, COPD)
• Chronic or severe acute diseases of nose or eyes
• Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
• Therapy with immunoglobulins
• Completed or ongoing treatment with anti-IgE-antibody
• Malignancy within the previous 5 years
• Alcohol, drug, or medication abuse within the past year and/or during the study
• Use of non-allowed medication (see section 5.3.1)
• Contraindications for SLIT (Pitsios et al., 2015)
• Contraindications for SPT
• Contraindication for NPT
• Relationship or dependence with the sponsor and/or investigator
• Legal incapacity
• Patients who are jurisdictional or governmentally institutionalized
• Serious systemic reactions to allergen-specific immunotherapy in the past
• Active chronic urticaria
• Active severe atopic eczema
• Existing or intended pregnancy, lactation or inadequate contraceptive measures for
woman with child-bearing potential or a positive pregnancy test at screening
• Severe psychiatric, psychological, or neurological disorders; completed or ongoing longterm
treatment with tranquilizers or psychoactive drugs (including tricyclic
antidepressants)
• Risk of non-compliance by the patient with study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method