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Phase II-III study to assess the efficacy and safety of sublingual immunotherapy in patients suffering from grass pollen allergy
EU CTIS ID: 2023-505880-35-00
What this study is testing
The purpose of this trial is to establish the most effective and best tolerated dose of SULGEN® Spray Phleum pratense in terms of benefit-risk balance and CSMS (Combined Symptom and Medication Score).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who signed and dated the 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 / rhinoconjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, either with well-controlled mild-to-moderate asthma defined in GINA guideline (Global Initiative for Asthma, 2022) or without asthma
- Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
- Sensitization to Phleum pratense pollen, verified by: 1. positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and 2. serum allergen-specific IgE to Phleum pratense ≥ 0.7 kU/L (CAP EAST class ≥ 2) and 3. a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during one of the two GPS preceding enrolment and 4. positive response to nasal provocation with Phleum pratense pollen allergen extract (at least at the third 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
You likely can't join if
- Previous immunotherapy with grass pollen allergen extracts 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
- Serious systemic reactions to allergen-specific immunotherapy in the past
- Hypersensitivity to excipients of the IMP
- Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
- Severe, or partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2022)
- Asthmatic patients with FEV1 ≤ 70 % of predicted normal value at screening
See the full eligibility criteria
Who can join
- Patients who signed and dated the 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 / rhinoconjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, either with well-controlled mild-to-moderate asthma defined in GINA guideline (Global Initiative for Asthma, 2022) or without asthma
- Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
- Sensitization to Phleum pratense pollen, verified by: 1. positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and 2. serum allergen-specific IgE to Phleum pratense ≥ 0.7 kU/L (CAP EAST class ≥ 2) and 3. a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during one of the two GPS preceding enrolment and 4. positive response to nasal provocation with Phleum pratense pollen allergen extract (at least at the third 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
- Compliance and ability of the patient to complete an electronic diary for self-evaluation of the symptoms and rescue medication
- Safety laboratory results within the normal range or considered to be not clinically significant in any other case
What rules you out
- Previous immunotherapy with grass pollen allergen extracts 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
- Serious systemic reactions to allergen-specific immunotherapy in the past
- Hypersensitivity to excipients of the IMP
- Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
- Severe, or partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2022)
- Asthmatic patients with FEV1 ≤ 70 % of predicted normal value at screening
- 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 an anti-IgE-antibody (like Omalizumab) and/or checkpoint-inhibitor
- Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
- Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen (with exception of any other Poaceae), 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
- Severe acute or chronic inflammatory or infectious diseases
- Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function
- Malignancy within the previous 5 years
- Active chronic urticaria
- Active severe atopic eczema
- Alcohol, drug, or medication abuse within the past year and/or during the study
- Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening
- Use of non-allowed medication
- Severe psychiatric, psychological, or neurological disorders; completed or ongoing longterm treatment with tranquilizer or psychoactive drugs (including tricyclic anti-depressants)
- Relationship or dependence with the sponsor and/or investigator
- Patients with co-sensitizations to any mould or pollen with overlapping season 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)
- Legal incapacity
- Patients who are jurisdictional or governmentally institutionalized
- Risk of non-compliance by the patient with the study procedures
- Simultaneous participation in other clinical trials
- Simultaneous specific immunotherapy with other allergens
- Participation in a clinical trial in the last three months before enrolment
- Contraindications for SLIT (Pitsios et al., 2015)
- Contraindications for SPT
- Contraindications for NPT
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.