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.

INTERVENTION: 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: 8000045‐25‐2 Other descriptive name: ALLERGENS, POLLEN & PLANT EXTRACT Concentration unit: U unit(s) Concentration type: range Concentration number: 100‐6000 CONDITION: 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 version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855 ; MedDRA version: 20.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: 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. 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) Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: After database lock SECONDARY OUTCOME: Secondary end point(s): Not applicable Timepoint(s) of evaluation of this end point: Not applicable 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 < 2 mm (negative control) • Immunoassay result for specific IgE = 0.70 kU/L to grass pollen 5. At least 1 month symptoms of allergic rhinitis or rhinoconjunctivitis in May to August triggered by grass pollen exposure over the last two seasons. 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) 6. In case of bronchial asthma at entry: confirmed diagnosis of asthma according to GINA guideline