A clinical study conducted in several test centers to investigate the safety of an accelerated high dose escalation schedule for an immune therapy in patients with hayfever with or without asthma.

A multicentre, randomized, open label clinical trial for safety evaluation of an accelerated high dose escalation schedule with one strength for an allergen immunotherapy with an aluminium hydroxide adsorbed allergoid preparation of 6-Grasses in patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without asthma. - ONSeT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000754-19-DE

Enrollment

Registered

2017-05-11

Start date

2017-11-09

Completion date

Unknown

Last updated

2018-10-15

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

Conditions

Patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without asthma MedDRA version: 20.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 100000004870 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 MedDRA vers

Interventions

Trade Name: Allergovit® 6-Grasses Product Name: Allergovit® 6-Grasses Product Code: 553a/91a-b Pharmaceutical Form: Suspension for injection INN or Proposed INN: Allergovit® 6-grasses CAS Number: 8000

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient) 2. Legally competent male or female outpatient 3. Age between 18 to = 65 years 4. IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by grass pollen documented by: • Skin prick test (SPT): • wheal for grass pollen = 3 mm in diameter • Histamine wheal = 3 mm (positive control) • NaCl reaction =65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: General criteria: 1. Patient is unable to understand and comply with the requirements of the trial, as judged by the investigator 2. Currently participating in any other clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial 3. Low compliance or inability to understand instructions/trial documents 4. Involvement in the planning and conduct of the trial 5. Employee of Allergopharma GmbH & Co. KG or of one of the trial sites 6. Any relationship of dependence with the sponsor or with the investigator 7. Previous randomization to treatment in the present trial 8. Mentally disabled 9. Institutionalized due to an official or judicial order For females with childbearing potential (i.e. females who are not chemically or surgically sterilized or females who are not post-menopausal): 10. Positive pregnancy test or pregnant 11. Use of an unacceptable or unreliable contraceptive method during the trial, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year) 12. Wish to breast feed or breast feeding 13. Wish to become pregnant during the course of the trial Immunotherapy criteria: 14. History of a confirmed anaphylaxis after an AIT injection 15. AIT with grass pollen within the last 5 years 16. Current treatment with any kind of immunotherapy 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 (ECSC) under adequate asthma treatment according to GINA guidelines (GINA, 2017) 20. Uncontrolled or partly controlled asthma according to GINA guidelines (GINA, 2017) 21. Acute asthma attack within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency visit 22. Rhinoconjunctival atopic symptoms for 20 years or longer 23. Severe acute or chronic diseases (e.g. chronic urticaria, mastocytose, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys) 24. 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) 25. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) 26. Recurrent seizures (e.g. febrile convulsion, untreated epilepsy) 27. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis) 28. 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). For assessment the normal ranges of the central laboratory should be applied. Medications: 29. Use of beta-blockers (locally or systemically), ACE inhibitors 30. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension) 31. Completion or ongoing treatment with anti-IgE-antibody 32. Completion or ongoing long-term treatment with tranquilizer or other psychoactive drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this therapeutic phase II trial is to evaluate the safety and tolerability of an accelerated high dose escalation schedule with one strength for allergen immunotherapy with Allergovit® 6-Grasses compared to the standard escalation schedule with two strengths. Adult patients with rhinitis or rhinoconjunctivitis caused by grass pollen, with or without allergic asthma on a well controlled level, will be enrolled. ;Secondary Objective: Not applicable;Primary end point(s): The aim of the trial is to obtain information about the safety and tolerability of an accelerated dose escalation schedule with one strength for allergen immunotherapy with Allergovit® 6-Grasses. The following descriptive safety variables will be considered: • 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 • Number, incidence, time of onset, type and intensity of AEs and serious adverse events assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term • Incidence and intensity of allergic systemic reactions after injections according to the World Allergy Organization (WAO) grading system (see Section 18.4) • Number of patients reaching the maintenance dose without dose adjustment due to adverse events • Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase • Change of vital signs and lung function measured before and after the treatment phase • Assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932);Timepoint(s) of evaluation of this end point: After database lock	—

Measure

Time frame

Main Objective: The main objective of this therapeutic phase II trial is to evaluate the safety and tolerability of an accelerated high dose escalation schedule with one strength for allergen immunotherapy with Allergovit® 6-Grasses compared to the standard escalation schedule with two strengths. Adult patients with rhinitis or rhinoconjunctivitis caused by grass pollen, with or without allergic asthma on a well controlled level, will be enrolled. ;Secondary Objective: Not applicable;Primary end point(s): The aim of the trial is to obtain information about the safety and tolerability of an accelerated dose escalation schedule with one strength for allergen immunotherapy with Allergovit® 6-Grasses. The following descriptive safety variables will be considered: • 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 • Number, incidence, time of onset, type and intensity of AEs and serious adverse events assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term • Incidence and intensity of allergic systemic reactions after injections according to the World Allergy Organization (WAO) grading system (see Section 18.4) • Number of patients reaching the maintenance dose without dose adjustment due to adverse events • Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase • Change of vital signs and lung function measured before and after the treatment phase • Assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932);Timepoint(s) of evaluation of this end point: After database lock

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Germany, Poland, Russian Federation, Spain

Contacts

Public ContactDr. Kirsten Plückhahn

Allergopharma GmbH & Co. KG

kirsten.plueckhahn@allergopharma.com00494072765470

Outcome results

None listed

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