A prospective, randomized, double-blind placebo-controlled multicentre study with 10 000 mTU/mL mannan-conjugated birch pollen allergoids administered subcutaneously to patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
- Conditions
- Treatment of birch pollen-induced allergic rhinitis or rhinoconjunctivitis.MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2021-002252-36-DE
- Lead Sponsor
- Inmunotek S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 360
Patients must meet all of the following inclusion criteria in order to participate in this study:
•Signed and dated Informed Consent Form by a legally competent patient,
•Female, male or diverse patients aged 18 to 64 years,
•Being in good physical and mental health,
•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*),
•For females: non-pregnant, non-lactating with adequate contraception as defined in chapter VI.1, or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]),
•Having the diagnosis of birch pollen allergy based on all the following criteria:
-A medical history of moderate to severe allergic rhinoconjunctivitis for birch pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA),
-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,
-Specific IgE against birch pollen allergens (minimum CAP class 3 or higher, =3.5 kU/L),
•Being treated with anti-allergic medication for at least 2 seasons prior to enrolment,
•For asthmatic patients: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2021),
•FEV1 =80% of the patient’s reference value or Peak Expiratory Flow (PEF) =80% of the patients´ individual optimal value (for asthmatic patients only).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
•Previous immunotherapy with birch pollen allergens within the last 5 years,
•Ongoing immunotherapy with birch pollen allergens or any other allergens,
•Patients with acute allergic rhinoconjunctivitis due to other environmental allergens during the study period,
•Patients with a sensitization to other environmental allergens (e.g., house dust mites, cat dander, dog dander) and whose CAP class of the respective allergen specific IgE is equal or higher than for birch pollen specific IgE,
•Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
•Inability to understand instructions/study documents,
•Patients who do not have access to a smartphone/tablet (iOS or Android)#,
•History of severe systemic reactions and/or anaphylaxis, including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc.,
•Patients who have a suspected or symptoms of a SARS-COV-2 infection, who have had contact with a confirmed case of COVID-19.
•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 2021) during the treatment period,
•Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) <80% of the patient’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the patients’ individual optimal value,
•History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening,
•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 – see Chapter Non-allowed drugs and procedures”,
•Use of systemic immunosuppressive medications (e.g., methotrexate or cyclosporine A) or blood transfusion one month before screening,
•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 an adequate contraceptive method,
•Administration of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within a defined time period preceding the trial (screening visit), as defined in the protocol, exception made for routine (previously prescribed) control medication for asthmatic patients,
•Clinically relevant laborator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method