Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis

PHASE3UnknownINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

December 31, 2022

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2025

Conditions
House Dust Mite AllergyPerennial Allergic RhinitisAllergic RhinoconjunctivitisAllergic Asthma
Interventions
BIOLOGICAL

MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for subcutaneous administration.

BIOLOGICAL

MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for sublingual administration.

BIOLOGICAL

MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 9.000 UTm/mL for sublingual administration.

BIOLOGICAL

Placebo subcutaneous

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

BIOLOGICAL

Placebo sublingual

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

Trial Locations (16)

12540

Hospital Universitario de la Plana, Vila-real

15006

Hospital Universitario A Coruña, A Coruña

29004

Hopital Quirón Salud Málaga, Málaga

29005

Clinica del Dr.Pérez Estrada Cornejo, Málaga

29010

Hospital Universitario Regional de Málaga, Málaga

31008

Hospital Universitario de Navarra, Pamplona

36071

Complexo Hospitalario Universitario de Pontevedra, Pontevedra

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

46026

Hospital Univeristario y Politécnico La Fe, Valencia

52006

Clínica RUSADIR, Melilla

03203

Hospital Universitario de Elche, Elche

07800

Policlínica Nuestra Sra del Rosario, Ibiza Town

08950

Hospital Sant Joan de Déu, Esplugues de Llobregat

08227

Hospital de Terrassa, Terrassa

03010

Hospital General Universitario de Alicante, Alicante

03015

Centro Médico Quiron Salud Alicante, Alicante

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

BioClever 2005 S.L.

OTHER

collaborator

NTS hub S.L

UNKNOWN

lead

Inmunotek S.L.

INDUSTRY

NCT05400811 - Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis | Biotech Hunter | Biotech Hunter