A randomized, double-blind, placebo-controlled dose selection study with two RP 01 formulations evaluating anti-IgE immunotherapy in allergic patients

INTERVENTION: Product Name: RP 01 Pharmaceutical Form: Solution for injection Current Sponsor code: RES 08 Other descriptive name: OSO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.4‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: RP 01 Pharmaceutical Form: Solution for injection Current Sponsor code: RES 08 Other descriptive name: OSO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.6‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: RP 01‐B Pharmaceutical Form: Solution for injection Current Sponsor code: RES 08 Other descriptive name: OSO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.1‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: RP 01‐B Pharmaceutical Form: Solution for injection Current Sponsor code: RES 08 Other descriptive name: OSO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.4‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: RP 01‐B Pharmaceutical Form: Solution for injection Current Sponsor code: RES 08 Other descriptive name: OSO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.6‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use CONDITION: Allergy ; MedDRA version: 9.1 Level: LLT Classification code 10001738 Term: Allergy PRIMARY OUTCOME: Main Objective: The primary objective is to establish the maximum tolerable effective dose of RP 01 as an anti‐IgE immunotherapy in allergic patients. Adverse events (AEs), laboratory safety variables and the specific immune response markers IgG anti‐IgE and IgG anti‐OSO will be assessed. Primary end point(s): Efficacy assessments included in the study are based on various specific immune response markers:; ‐ Induction of IgG anti‐OSO antibodies and IgG anti‐IgE antibodies.; ‐ Expression of FceRI on blood basophils.; ‐ Induction of IgE neutralizing antibodies; ‐ Levels of total IgE and free IgE.; ‐ Basophil activation.; Bullets 3‐5 represents exploratory variables.; Secondary Objective: The secondary objective is to compare two different formulations of RP 01 in terms of safety, tolerability and efficacy. This will be assessed by adverse events (AEs), laboratory safety variables, expression of FceRI on blood basophiles and the specific immune response markers IgG anti‐IgE and IgG anti‐OSO. INCLUSION CRITERIA: 1. Male patient aged between 18 and 60 years, inclusive. 2. Allergy to at least one of the following aero allergens; cat, dog, horse, timothy grass, birch, mugwort, house dust mite and cladosporium herbarum, verified by an elevated specific IgE level (=0,50 kU/l IgE; ImmunoCAP®). 3. Mentally competent with the ability to understand and comply with the requirement of the study 4. Signed informed consent to participate in the study 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range