Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose.
4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e. comparison between treatment arms of increased amount of quantities of allergen to provoke a positive CPT at the end of treatment.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients have provided an appropriately signed and dated informed consent prior to any study specific examination,
. Patients must be ≥ 18 and ≤ 70 years of age at Visit 1,
. Patients must have a perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS),
. Patients must have an FEV1 or PEF value \> 80% of the predicted normal value (for PEF: highest result of 3 measurements),
. Patients must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years with or without intermittent asthma symptoms, caused by clinical sensitization against birch pollen,
. IgE-mediated sensitization has to be verified by:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Conjunctival Provocation Test
Timeframe: At screening and after approx 22 weeks (EoS)
. Patients do not suffer from typical symptoms against co-allergens,
. Specific CAP-RAST against co-allergens \< CAP-RAST against birch pollen (the difference has to be ≥ 2), patients with co-allergens against animal dander can be randomized even if the CAP RAST difference is \< 2, but must not be exposed to the specific allergen,
Exclusion criteria
. Acute and chronic conjunctivitis,
. Infectious conjunctivitis,
. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites),
. Symptoms due to co-allergies,
. Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines,
. Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis,
. Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis),
. Diseases of the immune system including autoimmune and immune deficiencies,