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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00439621
Enrollment
42
Registered
2007-02-23
Start date
2007-02-28
Completion date
2008-08-31
Last updated
2008-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

immunotherapy, allergy

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.

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.

Interventions

BIOLOGICALRP 01

Active immunotherapy

Sponsors

Resistentia Pharmaceuticals AB
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Adverse Events0-12 months

Secondary

MeasureTime frame
Immune kinetic parameters0-12 months

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026