Clinical Trials Logo
  1. Home
  2. Allergic Rhinitis
  3. NCT00584584
  4. Details
NCT00584584 Clinical Trial

An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever

Allergic Rhinitis Clinical Trial

Official title:
A Proof of Concept Study of the Effects of QAX576 (an Interleukin-13 Monoclonal Antibody) on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00584584
Other study ID # CQAX576A2104
Secondary ID
Status Completed
Phase Phase 2
First received December 21, 2007
Last updated February 22, 2017
Start date December 2007

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- History of allergic rhinitis.

Exclusion Criteria:

- Respiratory disease other than mild intermittent asthma.

- Received immunotherapy in past 3 years.

- History of clinically significant drug allergy.

- History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.

- History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• QAX576

• Placebo

Locations
Country Name City State
Germany Novartis Investigator Site Hannover
United Kingdom Novartis Investigator Site London

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Markers of allergic inflammation in the nose measured over 5-8 days post-dose. throughout the study
Secondary - Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose. throughout the study
See also
  Status Clinical Trial Phase
Recruiting NCT05080322 - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis Phase 4
Recruiting NCT06028490 - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis. Phase 2
Completed NCT04388358 - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation N/A
Recruiting NCT04202263 - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline Phase 2
Completed NCT04078009 - Standardising Nasal Allergen Challenge in Adult With Hay Fever N/A
Completed NCT03644680 - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study N/A
Completed NCT04541004 - Adolescent Mite Allergy Safety Evaluation Phase 3
Recruiting NCT05378594 - HDM and Silver Birch NAC Standardisation N/A
Not yet recruiting NCT05684380 - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER) Phase 3
Completed NCT02943720 - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen Phase 2
Completed NCT02910401 - Clinical Response to Rhinovirus Challenge Phase 2
Not yet recruiting NCT01014325 - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy Phase 3
Completed NCT02556801 - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy Phase 2
Completed NCT02352168 - Airway Inflammation in Children With Allergic Rhinitis and Intervention N/A
Not yet recruiting NCT02233426 - Effect of Hypertonic Solutions on Allergic Rhinitis Patients N/A
Completed NCT01918956 - PURETHAL Birch RUSH Study Phase 4
Completed NCT01946035 - Alpha-Blockers in Allergic Rhinitis (MAN 01) Phase 4
Completed NCT01682070 - SUBLIVAC FIX Phleum Pratense DT/DRF Phase 2
Recruiting NCT01454492 - The Relationship Between Allergic Rhinitis and Geographic Tongue N/A
Completed NCT01438463 - PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis Phase 2

External Links