A multi-centre, randomised, double blind, placebo controlled study to determine the optimal effective and safe dose of Pollinex Quattro Grass 1.0 mL (Allergy Therapeutics, (UK) Ltd.) for the treatment of patients with seasonal allergic rhinoconjunctivitis due to grass pollen.

INTERVENTION: Product Name: Pollinex Quattro Grass 1.0 mL (300 SU/mL) Pharmaceutical Form: Suspension for injection INN or Proposed INN: MODIFIED ALLERGEN TYROSINE‐ADSORBED Other descriptive name: GRASS POLLEN MODIFIED ALLERGEN TYROSINE‐ADSORBED Concentration unit: SU/ml Standardised Unit(s)/millilitre (Deprecated) Concentration type: equal Concentration number: 300‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: Pollinex Quattro Grass 1.0 mL (800 SU/mL) Pharmaceutical Form: Suspension for injection INN or Proposed INN: GRASS POLLEN MODIFIED ALLERGEN TYROSINE‐ADSORBED Other descriptive name: GRASS POLLEN MODIFIED ALLERGEN TYROSINE‐ADSORBED Concentration unit: SU/ml Standardised Unit(s)/millilitre (Deprecated) Concentration type: equal Concentration number: 800‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: Pollinex Quattro Grass 1.0 mL (900 SU/mL) Pharmaceutical Form: Suspension for injection INN or Proposed INN: GRASS POLLEN MODIFIED ALLERGEN TYROSINE‐ADSORBED Other descriptive name: GRASS POLLEN MODIFIED ALLERGEN TYROSINE‐ADSORBED Concentration unit: SU/ml Standardised Unit(s)/millilitre (Deprecated) Concentration type: equal Concentration number: 900‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: Pollinex Quattro Grass 1.0 mL (2000 SU/mL) Pharmaceutical Form: Suspension for injection INN or Proposed INN: GRASS POLLEN MODIFIED ALLERGEN TYROSINE‐ADSORBED Other descriptive name: GRASS POLLEN MODIFIED ALLERGEN TYROSINE‐ADSORBED Concentration unit: SU/ml Standardised Unit(s)/millilitre (Deprecated) Concentration type: equal Concentration number: 2000‐ Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use Product Name: Pollinex Quattro Grass 1.0 mL (2700 SU/m CONDITION: Grass pollen‐induced seasonal allergic rhinoconjunctivitis ; MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 Therapeutic area: Body processes [G] ‐ Immune system processes [G12] PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the dose‐response of Pollinex Quattro Grass 1.0 mL in patients with grass pollen‐induced rhinoconjunctivitis. Primary end point(s): The primary efficacy endpoint is the post‐treatment TSS following CPT. Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of different doses of Pollinex Quattro Grass 1.0 mL in patients with grass pollen‐induced rhinoconjunctivitis. Timepoint(s) of evaluation of this end point: Day 81 to 89 depending on visit 2 day SECONDARY OUTCOME: Secondary end point(s): Efficacy: ; The secondary efficacy endpoints are: ; 1. Change from baseline to post‐treatment TSS following CPT. ; 2. Number of additional allergen concentration steps required to elicit a positive CPT (i.e. TSS = 6, ; adjusted for reference eye score) post‐treatment. INCLUSION CRITERIA: 1. Understands the implications of trial participation, provided in local language in the written informed consent form (ICF), and demonstrates willingness to comply with instructions and to attend the required study visits and has signed the informed consent. 2. Male or female aged 18 to 50 years inclusive at the time of signing Informed Consent. 3. Female patients are allowed to participate in the study if they are: a. Not of childbearing potential defined as: post‐menopausal (defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause) or, ; 3. Change in total Immunoglobulin E (IgE), grass specific IgE, grass specific immunoglobulin G(IgG)4, and specific IgE/total IgE ratio between screening and post‐treatment. Timepoint(s) of evaluation of this end point: Day 81 to 89 depending on visit 2 day b. Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study screening) or, c. Non‐pregnant, non‐lactating with negative urinary pregnancy test at all visits leading up to randomization and who use at least one of the following effective contraceptive methods:

Epistemonikos ID: 62e819c30a2eeecc17ba3f7f1751bf6d17a38917
First added on: Aug 23, 2024