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Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen

NCT04891237 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-05-07

No results posted yet for this study

Summary

Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive

Conditions

  • Rhinitis, Allergic
  • Rhinoconjunctivitis
  • Asthma, Allergic

Interventions

BIOLOGICAL

10,000 MG01 + 10,000 T517

Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

BIOLOGICAL

30,000 MG01 + 10,000 T517

Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

OTHER

Placebo

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

Sponsors & Collaborators

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Irán Sánchez · Private Site

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
2021-06-14
Primary Completion
2026-01-31
Completion
2027-01-31

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 NCT04891237 on ClinicalTrials.gov