Safety Study of Anti-IgE Immunotherapy in Allergic Patients
- Conditions
- Allergy
- Interventions
- Biological: RP 01
- Registration Number
- NCT00439621
- Lead Sponsor
- Resistentia Pharmaceuticals AB
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
- Allergy to at least one aero allergen
- Increased serum IgE level
- Diagnosis of asthma
- Recent use of systemic corticosteroids or immunosuppressive treatment
- Allergy vaccination therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 RP 01 - 1 RP 01 - 2 RP 01 - 3 RP 01 -
- Primary Outcome Measures
Name Time Method Adverse Events 0-12 months
- Secondary Outcome Measures
Name Time Method Immune kinetic parameters 0-12 months
Trial Locations
- Locations (1)
P3 Research
🇳🇿Wellington, New Zealand