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

Cytos Biotechnology

Status and phase: Completed; Phase 2

Conditions: Rhinoconjunctivitis; Allergies

Treatments: Drug: CYT003-QbG10; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800332

CYT003-QbG10 09

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: CYT003-QbG10

2

Experimental group

Treatment:

Drug: CYT003-QbG10

3

Placebo Comparator group

Treatment:

Drug: Placebo