Safety Study of Anti-IgE Immunotherapy in Allergic Patients

This study has been completed.
Sponsor:
Information provided by:
Resistentia Pharmaceuticals AB
ClinicalTrials.gov Identifier:
NCT00439621
First received: February 22, 2007
Last updated: August 13, 2008
Last verified: August 2008

February 22, 2007
August 13, 2008
February 2007
March 2008   (final data collection date for primary outcome measure)
Adverse Events [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
Adverse Events throughout the 1 year study
Complete list of historical versions of study NCT00439621 on ClinicalTrials.gov Archive Site
Immune kinetic parameters [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
Immune kinetic parameters throughout the 1 year study
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Allergy
Biological: RP 01
Active immunotherapy
  • Experimental: 1
    Intervention: Biological: RP 01
  • Experimental: 2
    Intervention: Biological: RP 01
  • Experimental: 3
    Intervention: Biological: RP 01
  • Placebo Comparator: 4
    Intervention: Biological: RP 01
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
August 2008
March 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00439621
2006-24
Yes
Not Provided
Resistentia Pharmaceuticals AB
Not Provided
Study Director: Vidar Wendel-Hansen, MD, PhD Resistentia Pharmaceuticals AB
Resistentia Pharmaceuticals AB
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP