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Recruiting Phase 3 NCT04898283

Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

Trial Parameters

Condition Rhinitis, Allergic
Sponsor Inmunotek S.L.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 180
Sex ALL
Min Age 12 Years
Max Age 65 Years
Start Date 2021-05-31
Completion 2026-10
Interventions
10,000 MG01 +10,000 T52130,000 MG01 +10,000 T521Placebo subcutaneous

Brief Summary

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.

Eligibility Criteria

Inclusion Criteria: 1. Written informed consent. 2. Aged between 12 and 65, both genders 3. Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis according to ARIA classification, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen. 4. Subjects with a positive skin prick-test (wheal size \>5 mm diameter) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to one of the molecular components of the mixture and to a cupressaceae extract. In addition, the largest diameter of the papules must be greater than or equal to that of the histamine. 5. Specific IgE \> 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite). 6. Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result

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