Title
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
Phase
Phase 2Lead Sponsor
Resistentia Pharmaceuticals ABStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
AllergyIntervention/Treatment
rp 01 ...Study Participants
42The 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.
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.
Inclusion Criteria: Allergy to at least one aero allergen Increased serum IgE level Exclusion Criteria: Diagnosis of asthma Recent use of systemic corticosteroids or immunosuppressive treatment Allergy vaccination therapy
