Safety Study of Anti-IgE Immunotherapy in Allergic Patients

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439621
• Other study ID #: 2006-24
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2007
• Last updated: August 13, 2008
• Start date: February 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: Resistentia Pharmaceuticals AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• RP 01
Active immunotherapy

Locations

Country	Name	City	State
New Zealand	P3 Research	Tauranga
New Zealand	P3 Research	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Resistentia Pharmaceuticals AB

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		0-12 months	Yes
Secondary	Immune kinetic parameters		0-12 months	Yes