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

NCT05400811 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-11-18

No results posted yet for this study

Summary

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

Conditions

  • House Dust Mite Allergy
  • Perennial Allergic Rhinitis
  • Allergic Rhinoconjunctivitis
  • Allergic 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.

Sponsors & Collaborators

  • BioClever 2005 S.L.

    collaborator OTHER

  • NTS hub S.L

    collaborator UNKNOWN

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Ana Isabel Tabar Purroy, MD. PhD · Hospital of Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-07-31
Completion
2025-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05400811 on ClinicalTrials.gov