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

Novartis

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Placebo; Drug: QAX576

Study type: Interventional

Funder types: Industry

Identifiers

NCT00584584

CQAX576A2104

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: QAX576

2

Placebo Comparator group

Treatment:

Drug: Placebo