2025-523653-34-00招募中2 期
Sublingual Birch Immunotherapy for Pollen-associated Food Allergy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change from baseline to Visit 5 in the combined global VAS (itching, stinging, prickling within 5 minutes after apple challenge)
研究概览
简要总结
To demonstrate superiority of a short-course SLIT with ITULAZAX over placebo in reducing pollen-associated food allergy symptoms during standardized apple challenge.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Sensitization to apple as evidenced by specific IgE against Mald1 > CAP class
- •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
- •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
排除标准
- •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).
研究组 & 干预措施
Gelatine (fish, high molecular weight), Gelatine (fish, standard molecular weight), Mannitol, Sodium hydroxide, Purified water
Placebo
干预措施: Gelatine (fish, high molecular weight), Gelatine (fish, standard molecular weight), Mannitol, Sodium hydroxide, Purified water (Drug)
ITULAZAX 12 SQ-Bet Lyophilisat zur sublingualen Anwendung
Test
干预措施: ITULAZAX 12 SQ-Bet Lyophilisat zur sublingualen Anwendung (Drug)
INFECTODIARRSTOP® LGG® Mono Beutel Pulver zur Herstellung einer Suspension zum Einnehmen für Säuglinge und Kleinkinder Wirkstoff: Lactobacillus rhamnosus GG (LGG) gefriergetrocknet, mindestens 5 x 109 KBE
Test
干预措施: INFECTODIARRSTOP® LGG® Mono Beutel Pulver zur Herstellung einer Suspension zum Einnehmen für Säuglinge und Kleinkinder Wirkstoff: Lactobacillus rhamnosus GG (LGG) gefriergetrocknet, mindestens 5 x 109 KBE (Drug)
结局指标
主要结局
Change from baseline to Visit 5 in the combined global VAS (itching, stinging, prickling within 5 minutes after apple challenge)
Change from baseline to Visit 5 in the combined global VAS (itching, stinging, prickling within 5 minutes after apple challenge)
次要结局
- Change from baseline to Visit 5 in the combined global VAS (itching, stinging, prickling within 5 minutes after apple challenge)
- Change from baseline to Visit 5 in the Modified Bergmann Score
- Change from baseline to Visit 5 in FAQLQ/FAIM total score
- Change from baseline to Visit 5 in asthma symptoms and disease control total score (in asthmatic patients)
- Change from baseline to Visit 5 in RDF symptoms (in IBS subgroup)
- Incidence of solicited treatment-emergent local and systemic reactions (WAO grading)
- Incidence of unsolicited treatment-emergent AEs and SAEs
- Incidence of anaphylaxis events
- Physical examinations and vital signs
- Use of rescue medication (Ceterizine, Prednisolon) to relief allergic symptoms as side effects
- Use of emergency medication (systemic steroids, high-dose antihistamines or adrenaline) to treat side-effects of the apple challenge
- Safety laboratory data
- Likert Tolerability Scale Score for treatment
- Change from baseline to Visit 5 in 5-point Likert Tolerability Scale Score after apple challange
- Treatment adherence (days of IMP intake vs. non-intake, drug accountability).
- Change from baseline to Visit 5 in systemic (serum concentrations of) total IgE, specific IgE, and IgG4 for Mal d1 and Bet v1
研究者
Zentrum für Allergie und Umwelt, AG Allergologie
Scientific
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
研究点 (1)
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