Completed

NCT Number: NCT00574223

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

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

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Key information

Conditions

Perennial Allergic Rhinoconjunctivitis Dust Mite Allergy House Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cytos Biotechnology (Sponsor's Headquarter)

Schlieren, CH-8952, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-placebo

Drug

subcutaneous injections at 8 visits

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

Sponsors and collaborators

Lead sponsor

Cytos Biotechnology AG

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Dec 17, 2007
Registry last updated: Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed