Safety Study of Anti-IgE Immunotherapy in Allergic Patients

NCT ID: NCT00439621

Last Updated: 2008-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-08-31

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.

Conditions

Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

RP 01

Intervention Type: BIOLOGICAL

Active immunotherapy

2

Group Type: EXPERIMENTAL

RP 01

Intervention Type: BIOLOGICAL

Active immunotherapy

3

Group Type: EXPERIMENTAL

RP 01

Intervention Type: BIOLOGICAL

Active immunotherapy

4

Group Type: PLACEBO_COMPARATOR

RP 01

Intervention Type: BIOLOGICAL

Active immunotherapy

Interventions

RP 01

Active immunotherapy

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Resistentia Pharmaceuticals AB

INDUSTRY

Sponsor Role: lead

Principal Investigators

Vidar Wendel-Hansen, MD, PhD

Role: STUDY_DIRECTOR

Resistentia Pharmaceuticals AB

Locations

P3 Research

Tauranga, , New Zealand

P3 Research

Wellington, , New Zealand

Countries

New Zealand

Other Identifiers

2006-24

Identifier Type: -

Identifier Source: org_study_id