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

Cytos Biotechnology

Status and phase: Completed; Phase 2

Conditions: Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy

Treatments: Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10); Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo; Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo; Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574704

CYT005-AllQbG10 03

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate perennial allergic rhinoconjunctivitis 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

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

2

Placebo Comparator group

Treatment:

Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo

3

Experimental group

Treatment:

Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo

4

Placebo Comparator group

Treatment:

Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo