Study on the efficacy and safety of three different doses of Lais Ambrosia tablets in patients with allergic rhinoconjunctivitis to pollen of Ambrosia

INTERVENTION: Product Name: Lais Ambrosia tablets 300 UA Product Code: NA Pharmaceutical Form: Orodispersible tablet INN or Proposed INN: AMBROSIA ARTEMISIIFOLIA L. CAS Number: NA Current Sponsor code: NA Other descriptive name: monomeric allergoid from ragweed pollen extract Concentration unit: U unit(s) Concentration type: equal Concentration number: 300‐ Product Name: Lais Ambrosia tablets 1000 UA Product Code: NA Pharmaceutical Form: Orodispersible tablet INN or Proposed INN: AMBROSIA ARTEMISIIFOLIA L. CAS Number: NA Current Sponsor code: NA Other descriptive name: monomeric allergoid from ragweed pollen extract Concentration unit: U unit(s) Concentration type: equal Concentration number: 1000‐ Product Name: Lais Ambrosia tablets 2000 UA Product Code: NA Pharmaceutical Form: Orodispersible tablet INN or Proposed INN: AMBROSIA ARTEMISIIFOLIA L. CAS Number: NA Current Sponsor code: NA Other descriptive name: monomeric allergoid from ragweed pollen extract Concentration unit: U unit(s) Concentration type: equal Concentration number: 2000‐ CONDITION: rhinoconjunctivitis allergic to ragweed pollen ; MedDRA version: 14.1 Level: PT Classification code 10054928 Term: Allergy to plants System Organ Class: 10021428 ‐ Immune system disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: to assess the efficacy and safety of treatment with sublingual specific immunotherapy (antiallergic vaccination) with allergoid monomeric ragweed (Ambrosia LAIS) in three different doses in patients with rhinoconjunctivitis to ragweed pollen Primary end point(s): The efficacy of immunotherapy with sublingual tablets allergoid LAIS Ambrosia will be assessed through the measurement of individual variation in specific nasal provocation test (NPT) performed with Ambrosia Allerkin Secondary Objective: to document the safety of treatment with LAIS Ambrosia (incidence of adverse events) Timepoint(s) of evaluation of this end point: ‐ basal assesment before the randomization (same day of the first IMP administration) SECONDARY OUTCOME: Secondary end point(s): Incidence of Adverse Events Timepoint(s) of evaluation of this end point: Randomizzation visit (basal, pre‐treatment),V2 after 30 +/‐ 2 dd since V1, V3 after 90 +/‐ 7 dd since V1 and V4 after 120 +/‐ 7 dd since V1. INCLUSION CRITERIA: ‐Signed Informed Consent ‐Male or female patients aged between 18 and 75 years with a documented history of at least two years of rhinitis and / or moderate to severe allergic rhinoconjunctivitis to ragweed pollen seasonal allergic asthma with or without controlled. ‐clinically relevant sensitization to ragweed pollen ‐Positive clinical history to ragweed pollen ‐Availability to attend the study visits requested by the protocol during the study participation ‐Negative Pregnancy Urinary test (if female in fertile age) ‐If woman is of fertile age, she has been using a highly efficacious method of birth control for at least one month before the study enrolment and agrees to continue the use for the entire duration of the study. ‐Capable to fully understand the protocol and be compliant to the instructions reported in the protocol itself. ‐Positive response to the TPN test. Are the trial subjects under 18? no Number of subjects for this age range: 0

Epistemonikos ID: 9c1805d32956f24ecf0933c021bdb1e100924976
First added on: Aug 22, 2024