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Safety Study of Anti-IgE Immunotherapy in Allergic Patients

R

Resistentia Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Allergy

Treatments

Biological: RP 01

Study type

Interventional

Funder types

Industry

Identifiers

NCT00439621
2006-24

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

42 participants in 4 patient groups, including a placebo group

1
Experimental group
Treatment:
Biological: RP 01
2
Experimental group
Treatment:
Biological: RP 01
3
Experimental group
Treatment:
Biological: RP 01
4
Placebo Comparator group
Treatment:
Biological: RP 01

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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