Study to investigate the safety of an accelarated (fast) dose escalation schedule using one strength birch pollen allergens as compared to the approved long (slow) two-dose escalation in adult and pediatric patients with allergic cold (with and w/o asthma).

A multicenter, randomized, open label clinical trial for safety evaluation of an allergen immunotherapy with an accelerated dose escalation schedule using one strength of an aluminium hydroxide adsorbed allergoid preparation of birch pollen allergens in adult and pediatric patients with moderate to severe seasonal allergic rhinitis or rhinoconjunctivitis with or without bronchial asthma. - ONSeT Birch (One strength Birch)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002317-34-DE

Enrollment

210

Registered

2021-11-19

Start date

2021-12-20

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate to severe seasonal allergic rhinitis or rhinoconjunctivitis with or w/o asthma caused by birch pollen allergens MedDRA version: 20.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853

Interventions

Product Name: Allergovit Birch Pharmaceutical Form: Suspension for injection Other descriptive name: WHITE BIRCH POLLEN ALLERGOID FORMALDEHYDE MODIFIED Concentration unit: U/ml unit(s)/millilitre Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent given from patient and if relevant parents/legal guardian(s) according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during routine management of the patient) 2. Age between 5 and = 65 years 3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by sensitization to birch pollen allergens documented by: • Positive Skin prick test (SPT) result to birch pollen allergens: - Birch pollen test solution (wheal diameter) = 3 mm and - Positive histamine-control reaction (wheal diameter) = 3 mm and - Negative NaCl 0.9%-control reaction (wheal diameter) =65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: General criteria: 1. Patients and, if relevant parents/legal guardian(s), are unable to understand and comply with the requirements of the trial, as judged by the investigator 2. Currently participation in another clinical trial or participation in any other clinical trial within 30 days prior to informed consent for this trial 3. Low adherence to trial procedures expected or inability to understand instructions/trial documents by participant and/or parents/legal guardian(s) 4. Involvement in the planning and conduct of the trial 5. Patients and, if relevant parents/legal guardian(s) is/are employee(s) of Allergopharma GmbH & Co. KG or of one of the trial sites or CRO 6. Any relationship of dependence with the sponsor or with the investigator(s) 7. Previous randomization to treatment in the present trial 8. Mentally disabled 9. Institutionalized due to an official or judicial order For female patients with childbearing potential 10. Positive urine pregnancy test or pregnant 11. Wish to become pregnant during the course of the trial 12. Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate of less than 1% per year) 13. Wish to breast feed or breast feeding Immunotherapy criteria: 14. History of a confirmed anaphylaxis after an AIT injection 15. AIT with birch pollen allergoids or allergens within the last 5 years 16. Current treatment with any kind of allergen immunotherapy (AIT) 17. AIT with unknown allergen within the last 5 years Diseases and health status: 18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy 19. Forced expiratory volume in 1 second (FEV1) < 70 % of predicted normal values according to Quanjer et al. (2012) under adequate asthma treatment according to GINA recommendation (GINA 2021) 20. Uncontrolled or partly controlled asthma according to GINA recommendation (GINA 2021) 21. Asthma exacerbation within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency unit visit requiring the use of systemic corticosteroid or change in controller medication 22. Severe acute or chronic diseases (e.g. COVID-19, chronic urticaria, mastocytosis, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys), acute viral and bacterial infections presenting with fever 23. Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease, multiple sclerosis) 24. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) 25. Recurrent seizures (e.g. febrile convulsion, untreated epilepsy) 26. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis) 27. For assessment the normal reference ranges of the central laboratory should be applied If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) will lead to exclusion of the patients (Generally, this applies to patients of all age groups in this trial). However, for laboratory values with ages specific

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the safety and tolerability of a One strength dose escalation scheme using One strength of Allergovit Birch for allergen immunotherapy (AIT) compared to the standard escalation scheme using 2 strength of Allergovit Birch in adults, adolescents, and children with allergic rhinitis/rhinoconjunctivitis caused by birch pollen allergens with or without allergic asthma on a well-controlled level ;Primary end point(s): descriptive safety variables 1) Number, incidence, time of onset, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term 2) Number, incidence, time of onset, type and intensity of AEs and serious adverse events assessed as IMP-related (by investigator) according to MedDRA primary SOC and preferred term 3) Incidence and intensity of allergic systemic reactions after injections according to the World Allergy Organization (WAO) grading system 4) Number of patients reaching the maintenance dose without dose adjustment due to adverse events 5) Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase 6) Change of vital signs and lung function measured before and after the treatment phase 7) Assessment of the overall tolerability at study end by the investigator and the patient using a 5 point Likert scale (Likert 1932) ;Timepoint(s) of evaluation of this end point: Endpoints 1 - 3 will be evaluated using cumulative data from every visit (except screening visit). Endpoint 4 will be evaluated at week 2 (Group I, One Strength) / at week 6 (Group II, Standard). Endpoints 5 and 6 will be evaluated at Screening (before IMP-injection) and Final Visit (14-28 days after last IMP-injection). Endpoint 7 will be evaluated retrospectively before the next injection, starting at Treatment-Visit 2 through the final visit.;Secondary Objective: not applicable	—

Measure

Time frame

Main Objective: to evaluate the safety and tolerability of a One strength dose escalation scheme using One strength of Allergovit Birch for allergen immunotherapy (AIT) compared to the standard escalation scheme using 2 strength of Allergovit Birch in adults, adolescents, and children with allergic rhinitis/rhinoconjunctivitis caused by birch pollen allergens with or without allergic asthma on a well-controlled level ;Primary end point(s): descriptive safety variables 1) Number, incidence, time of onset, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term 2) Number, incidence, time of onset, type and intensity of AEs and serious adverse events assessed as IMP-related (by investigator) according to MedDRA primary SOC and preferred term 3) Incidence and intensity of allergic systemic reactions after injections according to the World Allergy Organization (WAO) grading system 4) Number of patients reaching the maintenance dose without dose adjustment due to adverse events 5) Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase 6) Change of vital signs and lung function measured before and after the treatment phase 7) Assessment of the overall tolerability at study end by the investigator and the patient using a 5 point Likert scale (Likert 1932) ;Timepoint(s) of evaluation of this end point: Endpoints 1 - 3 will be evaluated using cumulative data from every visit (except screening visit). Endpoint 4 will be evaluated at week 2 (Group I, One Strength) / at week 6 (Group II, Standard). Endpoints 5 and 6 will be evaluated at Screening (before IMP-injection) and Final Visit (14-28 days after last IMP-injection). Endpoint 7 will be evaluated retrospectively before the next injection, starting at Treatment-Visit 2 through the final visit.;Secondary Objective: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): exploratory endpoint: •Serum specific IgG4 to Betula verrucosa pollen allergen extract;Timepoint(s) of evaluation of this end point: The exploratory endpoint will be evaluated at Screening and Final Visit.	—

Countries

Germany, Poland

Contacts

Public ContactClinical Development

Allergopharma GmbH & Co. KG

Christiane.Praechter@allergopharma.com+494072765614

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026