A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

Cytos Biotechnology AG100 enrolled

Overview

The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Perennial Allergic Rhinoconjunctivitis House Dust Mite Allergy

Interventions

CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)DRUG

subcutaneous injections at 8 visits

House dust mite allergen extract in combination with CYT003-QbG10-placeboDRUG

subcutaneous injections at 8 visits

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens Exclusion Criteria: * Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments * Use of any concomitant medication that could affect the patient's study treatment response or assessment results

Locations (1)

Cytos Biotechnology (Sponsor's Headquarter)

Schlieren, Switzerland

Outcomes

Primary Outcomes

Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life

Time frame: about 1.5 hours on 4 occasions over 1 year

Secondary Outcomes

Safety and tolerability of the study treatment by collection of adverse events

Time frame: about 30 min. at each visit

Data from ClinicalTrials.gov

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