A prospective, randomized, double-blind placebo-controlled multicentre trial with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescents and adults with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
- Conditions
- birch pollen-induced allergic rhinitis birch pollen-induced allergic rhinoconjunctivitis
- Registration Number
- 2024-515717-17-00
- Lead Sponsor
- Inmunotek S.L.
- Brief Summary
The primary objective of this trial is to assess the clinical impact of T502 treatment administered subcutaneously to participants with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
The effect will be assessed by comparing the symptoms and the medication need in actively treated and placebo participants during the peak birch pollen season.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 360
Participants aged from 12 to 64 years (at least 10% of the population should be 12-17 years of age)
Signed and dated Informed Consent Form , a. by a legally competent participant, b. For adolescents: self-completed (signed and dated) informed consent to participate in the trial and signed and dated Informed Consent Form by both parents/legal guardian(s)
Being in good physical and mental health.
Having the diagnosis of birch pollen allergy based on all the following criteria: a. A medical history of moderate to severe allergic rhinitis or rhinoconjunctivitis due to birch pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA), b. Being treated with anti-allergic medication for at least 2 birch pollen seasons prior to enrolment, c. A positive skin prick test (SPT - wheal diameter ≥3 mm) to birch pollen allergens, positive control (histamine) wheal ≥3 mm, negative control (NaCl) wheal <2 mm.
Females: a. With childbearing potential (a woman is considered of childbearing potential [WOCBP] according to the CTFG, if she is i.e., fertile, following menarche and until becoming postmenopausal unless becoming permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must be willing to use a highly effective method of contraception: • Oral, intravaginal or transdermal hormonal medical drugs or -devices containing oestrogen/progesterone combinations. • Oral, injectable or implantable hormonal medical drugs or -devices containing progesterone-only. • Intrauterine device (IUD); • Intrauterine hormone-releasing system (IUS); • Bilateral tubal occlusion; • Vasectomized partner (provided that partner is the sole sexual partner of the WOCB trial participant and that the vasectomized partner has received medical assessment of the surgical success); • Sexual abstinence (Defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant). b. Females unable to bear children (i.e., pre-menarche, tubal ligation, hysterectomy, or post-menopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause).
For asthmatic participants: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2023).
FEV1 ≥80% of the participant’s reference value or Peak Expiratory Flow (PEF) ≥80% of the participants´ individual optimal value (for asthmatic participants only) measured at the screening visit.
Laboratory tests: a. Specific IgE against birch pollen allergens (common silver birch t3, minimum CAP class 3 or higher, ≥3.5 kU/L); in case that the IgE CAP-class is =2, the participant can be included, when a previous lab report (not older than 2 years and measurement outside the birch pollen season) states that the participant has CAP class 3 or higher), b. Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (< grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials [FDA 2007] at screening visit. Participants with laboratory values ≥ grade 2 will require retesting before inclusion in the trial. Upon normalization of the out-of-range value(s), the participant can be included in the trial), c. Female participants with childbearing potential must have a negative pregnancy test in serum at screening.
Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion.
History of systemic reactions and/or anaphylaxis (Grade III or IV according to the AWMF guideline 2021), including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc.
History of hypersensitivity to the excipients of the investigational product or placebo.
Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2023) during the treatment period.
Chronic asthma or emphysema, particularly with a Forced Expiratory Volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participants’ individual optimal value measured at the screening visit.
Previous or ongoing respiratory tract infection (e.g., flu, COVID-19) and/or exacerbation of asthma within 4 weeks before the screening visit.
History of significant renal disease or chronic hepatic disease.
Malignant active disease (ongoing or within the five past years).
Severe autoimmune disease.
Immune defects including immunosuppression, immunopathies.
Vaccination during the entire treatment period, except flu and SARS-CoV-2 vaccinations.
Previous immunotherapy with birch pollen allergens within the last 5 years.
Use of systemic immunosuppressive medications (e.g., methotrexate or cyclosporine A) or blood transfusion from one month before screening until the end of the trial.
General inflammatory, severe acute or chronic inflammatory diseases.
Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g., doxepin, amitriptyline, desipramine, imipramine, etc.).
Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents.
Intake of beta-blockers/ACE inhibitor medication (angiotensin-converting enzyme inhibitor).
Active tuberculosis.
Having any contraindication for the use of adrenaline (including hyperthyroidism).
Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus.
Females who are pregnant, lactating, or of child-bearing potential and not using a highly effective contraceptive method.
Ongoing immunotherapy with birch pollen allergens or any other allergens
Administration of corticosteroids (systemic or nasal) or of anti-histaminic drugs within a defined time period preceding the trial (screening visit), as defined in the section Screening/Baseline Assessments and Procedures; exception made for routine (previously prescribed) control medication for asthmatic participants.
Laboratory values: a. Missing laboratory values relevant for inclusion, b. Participants with a clinically significant sensitization to other environmental allergens (i.e., house dust mites, cat dander, dog dander) and whose CAP class of the respective allergen specific IgE is higher than for birch pollen specific IgE (t3), c. Clinically relevant laboratory values (haematology, clinical chemistry), grade ≥2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit (Participants with laboratory values ≥ grade 2 will require retesting. Upon normalization of the out-of-range value(s), participant will be eligible).
Participants with acute allergic rhinitis or rhinoconjunctivitis due to other environmental allergens during the trial period.
Being in any relationship or dependence with the Sponsor, CRO and/or Investigator.
Inability to understand instructions/trial documents.
Participants for whom the Investigator believes that they will not comply with the protocol (participants with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as participants unwilling to give informed consent or to abide by the requirements of the protocol).
Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible).
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The clinical impact of T502 treatment will be assessed by comparing the mean daily Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2025 between the placebo and the active treatment group. The clinical impact of T502 treatment will be assessed by comparing the mean daily Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2025 between the placebo and the active treatment group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Praxis für HNO und Allergologie Dr. Yury Yarin
🇩🇪Dresden, Germany
Studienzentrum Dr. Sabine Lassmann
🇩🇪Saalfeld, Germany
MVZ Dr. Kasche und Kollegen GmbH
🇩🇪Hamburg, Germany
Praxisgemeinschaft Reiber & Partner
🇩🇪Schorndorf, Germany
HNO Praxis Dr. Thieme
🇩🇪Duisburg, Germany
Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
🇩🇪Leipzig, Germany
Zentrum für Rhinologie und Allergologie
🇩🇪Wiesbaden, Germany
Studienzentrum Dr. Christian Schlenska
🇩🇪Peine, Germany
Praxis Prof. Vent
🇩🇪Cologne, Germany
HNO-Praxis am Neckar Doctors Horn & Choudhry
🇩🇪Heidelberg, Germany
Scroll for more (13 remaining)Praxis für HNO und Allergologie Dr. Yury Yarin🇩🇪Dresden, GermanyYury YarinSite contact+4935142780555dr.yarin@googlemail.com