BridgeMD
Sublingual Birch Immunotherapy for Pollen-associated Food Allergy
EU CTIS ID: 2025-523653-34-00
What this study is testing
To demonstrate superiority of a short-course SLIT with ITULAZAX over placebo in reducing pollen-associated food allergy symptoms during standardized apple challenge.
- Therapeutic exploratory (Phase II)
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
- Written informed consent available.
- Patient history of birch pollen related food syndrome since more than 2 years with relevant symptoms to apple and a relevant FAQLQ/FAIM score ≥ 2.
- Sensitization to apple as evidenced by specific IgE against Mald1 > CAP class 1.
- Male and female patients aged between 18 to 65 years.
- Female participants with reproductive potential must have a negative beta-HCG serum pregnancy test as part of the screening visit.
- Female participants with reproductive potential must have in addition a negative urine pregnancy test on the day of randomization.
You likely can't join if
- Pregnancy or wish to become pregnant or lactation.
- History of currently relevant psychiatric disorder.
- Current or relevant history of intake of Betablockers, ACE-inhibitors, systemic steroids or immune-suppressants, antidepressants, neuroleptics or biologics.
- History of anaphylaxis to Birch-related food allergens or history of more than 2 systemic allergic reactions.
- Current participation in another clinical trial or participation in another clinical trial with IMP intake and if applicable wash-out phase within the last four weeks.
- Any history of laryngeal edema to birch-related food allergens.
See the full eligibility criteria
Who can join
- Written informed consent available.
- Patient history of birch pollen related food syndrome since more than 2 years with relevant symptoms to apple and a relevant FAQLQ/FAIM score ≥ 2.
- Sensitization to apple as evidenced by specific IgE against Mald1 > CAP class 1.
- Male and female patients aged between 18 to 65 years.
- Female participants with reproductive potential must have a negative beta-HCG serum pregnancy test as part of the screening visit.
- Female participants with reproductive potential must have in addition a negative urine pregnancy test on the day of randomization.
- Female participants with reproductive potential are required to use an acceptable birth control method. Acceptable birth control methods that result in a failure rate of less than 1% include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence. Acceptable birth control methods that result in a failure rate of more than 1% per year include: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male of female condom with or without spermicide, cap, diaphragm or sponge with spermicide
- Sensitization to Birch pollen as evidenced by a wheal >5mm in skin prick test and specific IgE against Betv1 > CAP class 2.
- Minimum compound global VAS of 3 for itch, stinging and prickling within 5 minutes after controlled apple challenge prior to randomization.
- The patient is able to understand the clinical trial and cooperate with the investigator.
- Patient history of moderate to severe allergic rhinitis and/or conjunctivitis (AR/C) with or without asthma to birch since more than 2 years
What rules you out
- Pregnancy or wish to become pregnant or lactation.
- History of currently relevant psychiatric disorder.
- Current or relevant history of intake of Betablockers, ACE-inhibitors, systemic steroids or immune-suppressants, antidepressants, neuroleptics or biologics.
- History of anaphylaxis to Birch-related food allergens or history of more than 2 systemic allergic reactions.
- Current participation in another clinical trial or participation in another clinical trial with IMP intake and if applicable wash-out phase within the last four weeks.
- Any history of laryngeal edema to birch-related food allergens.
- Any other history of currently relevant urticaria or angioedema.
- Maximum compound global VAS of ≥9 for itch, stinging and prickling after controlled apple challenge prior to randomization.
- Clinically relevant sensitization to nsLTP and other food relevant heat- stabile allergens as evidenced by spec. IgE > CAP class 1 and symptoms to cooked/processed fruit allergen sources.
- Intolerance to drug ingredients, these includes besides the active pharmaceutical ingredients: D-Glucose, Saccharose, Aspartame, Maltodextrin, Sodium ascorbate, Gelatine (fish source), Mannitol, Sodium hydroxide.
- Intolerance to the ingredients and contraindications of the rescue medication: Ceterizin: Sensitivity against Ceterizin and other ingredients, Hydroxyzine and other Piperazine derivatives. Patients with end-stage renal disease and an eGFR (estimated glomerular filtration rate) below 15 ml/min. Prednisolon: Sensitivity against Prednisolone and other ingredients
- Uncontrolled asthma or FEV1 <80%.
- Elevated serum-tryptase or any history of mastocytosis.
- Severe atopic dermatitis.
- Currently relevant history of eosinophil esophagitis.
- Patients with acute severe oral inflammation or oral wounds.
- Allergen-Immunotherapy within past 5 years.
- History of any other currently relevant the immune-system affecting pathology apart from allergy, such as e.g. active autoimmune diseases, malignancies, infectious diseases.
- History of currently relevant severe medical condition such as diabetes, severe hypertension, kidney, liver, gut or heart disease that requires treatment.
- History of currently relevant addiction (e.g. such as alcohol or drugs).
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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.