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OpenTrials
Completed

NCT Number: NCT00575003

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

The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.

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Key information

Conditions

Perennial Allergy to House Dust Mite and/or Cat

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tartu University Clinic, Lungs Clinic, Tartu, Estonia

Loading trial locations.

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 rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens

Exclusion criteria

  • Clinical 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.
  • Any clinically relevant concomitant disease as judged by the investigator.
  • Pregnancy or female planning to become pregnant during the study.

Treatment and study plan

CYT003-QbG10

Drug

6 subcutaneous injections

Primary outcomes

  1. Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life

    Time frame: on 4 occations over 1 year

Secondary outcomes

  1. Safety and tolerability of the vaccine by collection of adverse events

    Time frame: at each visit

Sponsors and collaborators

Lead sponsor

Cytos Biotechnology AG

Industry

Registry information

Official study title

Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis

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.