MedDataX Logo

Safety Study of Anti-IgE Immunotherapy in Allergic Patients

NCT ID: NCT00439621

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

immunotherapy allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

RP 01

Intervention Type BIOLOGICAL

Active immunotherapy

2

Group Type EXPERIMENTAL

RP 01

Intervention Type BIOLOGICAL

Active immunotherapy

3

Group Type EXPERIMENTAL

RP 01

Intervention Type BIOLOGICAL

Active immunotherapy

4

Group Type PLACEBO_COMPARATOR

RP 01

Intervention Type BIOLOGICAL

Active immunotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RP 01

Active immunotherapy

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Resistentia Pharmaceuticals AB

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vidar Wendel-Hansen, MD, PhD

Role: STUDY_DIRECTOR

Resistentia Pharmaceuticals AB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

P3 Research

Tauranga, , New Zealand

Site Status

P3 Research

Wellington, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

New Zealand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-24

Identifier Type: -

Identifier Source: org_study_id