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NOT YET RECRUITING
NCT05641272
PHASE2/PHASE3

Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract

Sponsor: Inmunotek S.L.

View on ClinicalTrials.gov

Summary

Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma. The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).

Official title: Prospective, Randomised, DBPC Clinical Trial to Evaluate the Efficacy and Safety of Polymerized and Mannan Conjugated Allergen Extract of Dermatophagoides for the Treatment of Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

Key Details

Gender

All

Age Range

12 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-11-01

Completion Date

2026-12-01

Last Updated

2023-10-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

3,000 MM09

Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 3.000 UTm/mL for sublingual immunotherapy.

BIOLOGICAL

9,000 MM09

Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 9.000 UTm/mL for sublingual immunotherapy.

OTHER

Placebo sublingual

The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.

Locations (1)

Fundación CIDEA

Buenos Aires, Paraguay, Argentina