Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy

Cytos Biotechnology AG300 enrolled

Overview

The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Rhinoconjunctivitis Allergies

Interventions

CYT003-QbG10DRUG

subcutaneous injection

PlaceboDRUG

subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens * Further criteria as defined in the study protocol Exclusion Criteria: * Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments * Clinically relevant perennial allergy/-ies other than house dust mites allergy * Contraindication to any study test or procedure * Further criteria as defined in the study protocol

Locations (8)

Cytos Investigator Sites

Paide, Tartu, Tallin, Rakvere, Estonia

Cytos Investigator Sites

Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach, Germany

Cytos Investigator Sites

Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen, Germany

Cytos Investigator Sites

N. Faliro, Hiraklion, Athens, Greece

Outcomes

Primary Outcomes

Rhinoconjunctivitis symptom and medication scores

Time frame: Pre- / Post-Treatment

Data from ClinicalTrials.gov

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