- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439621
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
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Tauranga, New Zealand
- P3 Research
-
Wellington, New Zealand
- P3 Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Active immunotherapy
|
Experimental: 2
|
Active immunotherapy
|
Experimental: 3
|
Active immunotherapy
|
Placebo Comparator: 4
|
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
Sponsor
Investigators
- Study Director: Vidar Wendel-Hansen, MD, PhD, Resistentia Pharmaceuticals AB
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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