Safety Study of Anti-IgE Immunotherapy in Allergic Patients

August 13, 2008 updated by: Resistentia Pharmaceuticals AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Tauranga, New Zealand
        • P3 Research
      • Wellington, New Zealand
        • P3 Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: RP 01
Active immunotherapy
Experimental: 2
Biological: RP 01
Active immunotherapy
Experimental: 3
Biological: RP 01
Active immunotherapy
Placebo Comparator: 4
Biological: RP 01
Active immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 0-12 months
0-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Immune kinetic parameters
Time Frame: 0-12 months
0-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Resistentia Pharmaceuticals AB

Investigators

  • Study Director: Vidar Wendel-Hansen, MD, PhD, Resistentia Pharmaceuticals AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 18, 2008

Last Update Submitted That Met QC Criteria

August 13, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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