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
Conditions
Interventions
Trade Name: Allergovit® 6-Grasses
Product Name: Allergovit® 6-Grasses
Product Code: 553a/91a-b
Pharmaceutical Form: Suspension for injection
Sponsors
Allergopharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent given from patient and 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 the routine management of the patient) 2. Age between 5 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General criteria: 1. Parents/legal guardian(s) are 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 by parents/legal guardian(s) 4. Involvement in the planning and conduct of the trial 5. Parent/legal guardian is 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 female patients with childbearing potential 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 according to Quanjer (Quanjer et al. 2012) 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. 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) 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. For adolescents: If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolesce
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. Children and adolescents 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 ContactStudy Start-up Country Specialist
Clinipace Worldwide (Accovion S.L.)
Outcome results
None listed