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Safety Study of Anti-IgE Immunotherapy in Allergic Patients

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ClinicalTrials.gov Identifier: NCT00439621
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : August 18, 2008
Sponsor:
Information provided by:
Resistentia Pharmaceuticals AB

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.

Condition or disease Intervention/treatment Phase
Allergy Biological: RP 01 Phase 2

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  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Safety and Tolerability Study of Repeated Doses of Anti-IgE Immunotherapy in Allergic Patients
Study Start Date : February 2007
Primary Completion Date : March 2008
Study Completion Date : August 2008

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



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 0-12 months ]

Secondary Outcome Measures :
  1. Immune kinetic parameters [ Time Frame: 0-12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439621


Locations
New Zealand
P3 Research
Tauranga, New Zealand
P3 Research
Wellington, New Zealand
Sponsors and Collaborators
Resistentia Pharmaceuticals AB
Investigators
Study Director: Vidar Wendel-Hansen, MD, PhD Resistentia Pharmaceuticals AB

ClinicalTrials.gov Identifier: NCT00439621     History of Changes
Other Study ID Numbers: 2006-24
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008

Keywords provided by Resistentia Pharmaceuticals AB:
immunotherapy
allergy