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Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

NCT04435990 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-13

No results posted yet for this study

Summary

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Conditions

  • Rhinitis, Allergic
  • Rhinoconjunctivitis
  • Asthma, Allergic

Interventions

BIOLOGICAL

10,000 MM09

Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL

BIOLOGICAL

30,000 MM09

Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL

BIOLOGICAL

Placebo subcutaneous

The same solution and presentation as the active treatment, but without active ingredients.

Sponsors & Collaborators

  • BioClever 2005 S.L.

    collaborator OTHER

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Francisco Moreno, MD · Centro Médico ASISA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT04435990 on ClinicalTrials.gov