NCT00439621

Safety Study of Anti-IgE Immunotherapy in Allergic Patients

A Randomized, Double-Blind, Placebo-Controlled Safety and Tolerability Study of Repeated Doses of Anti-IgE Immunotherapy in Allergic Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Resistentia Pharmaceuticals AB · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate safety and efficacy of three doses and two dosing regimens of RP01 as an anti-IgE immunotherapy in allergic patients.

Detailed description

Immunotherapy is based on the principle of eliciting an immune reaction in order to block the negative effect of a specific disease-causing protein. The potential to treat diseases by means of immunotherapy instead of using conventional drugs represents an attractive opportunity in a number of chronic disease areas, including asthma and allergy. Resistentia's model to treat allergic diseases, and ultimately asthma, is to use the immune system to produce antibodies against the IgE molecules themselves. The resulting anti-IgE antibodies intercept and form complexes with the IgE molecules before they can bind to the mast cells and basophils and are thus able to block any allergen-triggered inflammatory reaction. The approach works in all types of IgE-mediated allergies independently of allergen, and also in patients sensitive to multiple allergens. Comparisons: Three doses and two dosing regimes of RP01 will be compared as regards safety and effect.

Conditions

• Allergy

Interventions

Type	Name	Description
BIOLOGICAL	RP 01	Active immunotherapy

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-03-01
• Completion: 2008-08-01
• First posted: 2007-02-23
• Last updated: 2008-08-18

Locations

2 sites across 1 country: New Zealand