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
  Purpose

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 Intervention Phase
Allergy
Biological: RP 01
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Resistentia Pharmaceuticals AB:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune kinetic parameters [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: February 2007
Study Completion Date: August 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00439621     History of Changes
Other Study ID Numbers: 2006-24
Study First Received: February 22, 2007
Last Updated: August 13, 2008
Health Authority: New Zealand: Medsafe

Keywords provided by Resistentia Pharmaceuticals AB:
immunotherapy
allergy

ClinicalTrials.gov processed this record on October 20, 2014