Safety Study of Anti-IgE Immunotherapy in Allergic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439621
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : August 18, 2008
Information provided by:
Resistentia Pharmaceuticals AB

February 22, 2007
February 23, 2007
August 18, 2008
February 2007
March 2008   (Final data collection date for primary outcome measure)
Adverse Events [ Time Frame: 0-12 months ]
Adverse Events throughout the 1 year study
Complete list of historical versions of study NCT00439621 on Archive Site
Immune kinetic parameters [ Time Frame: 0-12 months ]
Immune kinetic parameters throughout the 1 year study
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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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
New Zealand
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Resistentia Pharmaceuticals AB
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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