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

Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00574223

Enrollment

100

Registered

2007-12-17

Start date

2007-11-30

Completion date

2009-03-31

Last updated

2009-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

House Dust Mite Allergy, Perennial Allergic Rhinoconjunctivitis

Brief summary

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

Interventions

DRUGCYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)

subcutaneous injections at 8 visits

DRUGHouse dust mite allergen extract in combination with CYT003-QbG10-placebo

subcutaneous injections at 8 visits

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life	about 1.5 hours on 4 occasions over 1 year

Secondary

Measure	Time frame
Safety and tolerability of the study treatment by collection of adverse events	about 30 min. at each visit

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026