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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574223

CYT005-AllQbG10 04

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: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

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

Arm 2

Placebo Comparator group

Treatment:

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