BridgeMD
Phase II-III study to assess the efficacy and safety of subcutaneous cluster-immunotherapy in patients suffering from Olea europaea pollen allergy
EU CTIS ID: 2024-511383-88-00
What this study is testing
The purpose of this trial is to establish the most effective and best-tolerated dose of CLUSTOID®/CLUXIN® Olea europaea 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 olive 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, 2023) or without asthma
- Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value (only for asthmatic patients).
- Sensitization to Olea europaea pollen, verified by: positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and serum allergen-specific IgE to Olea europaea ≥ 0.7 kU/L (CAP EAST class ≥ 2) and a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during one of the two OPS preceding enrolment and positive response to nasal provocation with either Olea europaea or cross-reactive Fraxinus excelsior 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 Olea europaea or other pollen allergen extracts according to the homologous group of the “Oleaceae 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, 2023)
- Asthmatic patients with FEV1 ≤ 80 % 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 olive 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, 2023) or without asthma
- Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value (only for asthmatic patients).
- Sensitization to Olea europaea pollen, verified by: positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and serum allergen-specific IgE to Olea europaea ≥ 0.7 kU/L (CAP EAST class ≥ 2) and a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during one of the two OPS preceding enrolment and positive response to nasal provocation with either Olea europaea or cross-reactive Fraxinus excelsior 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 Olea europaea or other pollen allergen extracts according to the homologous group of the “Oleaceae 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, 2023)
- Asthmatic patients with FEV1 ≤ 80 % 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 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 the exception of ash, privet and lilac tree for “Oleaceae group”), which interfere with the conduct of the study (e. g. with the tNPT or the CSMS recording), especially if the result in SPT for this allergen is higher than that for Olea europaea.
- 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 women with childbearing potential or a positive pregnancy test at screening.
- Systemic and local (eye drops) treatment with beta-blockers.
- Use of non-allowed medication.
- Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma).
- Patients with co-sensitizations to any mould or pollen with overlapping seasons but which are not cross-reactive with Olea europaea and, measured at the same time, with specific IgE levels ≥ class 2 CAP/PHADIA (unless the relevance can be excluded by component resolved diagnosis)
- Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizer or psychoactive drugs (including tricyclic anti-depressants).
- Relationship or dependence with the sponsor and/or investigator.
- 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, meaning randomization, in a trial in the last three months before enrolment.
- Contraindications for SCIT (Pfaar et al., 2022; Pitsios et al., 2015)
- Contraindications for SPT
- Contraindications for NPT
The study team makes the final eligibility decision.
Where it's taking place
- Azerbaijan
- 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 Azerbaijan; 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.