A randomized, double-blind, placebo-controlled dose selection study with two RP 01 formulations evaluating anti-IgE immunotherapy in allergic patients

• Conditions: Allergy; MedDRA version: 9.1Level: LLTClassification code 10001738Term: Allergy

• Registration Number: EUCTR2007-006551-39-SE
• Lead Sponsor: Resistentia Pharmaceuticals AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Male patient aged between 18 and 60 years, inclusive.
2.Allergy to at least one of the following aero allergens; cat, dog, horse, timothy grass, birch, mugwort, house dust mite and cladosporium herbarum, verified by an elevated specific IgE level (=0,50 kU/l IgE; ImmunoCAP®).
3.Mentally competent with the ability to understand and comply with the requirement of the study
4.Signed informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergies and Respiratory tract conditions
1.Diagnosis of asthma.
2.Prior experience of an anaphylactic reaction.

Concomitant medication
3.Use of systemic corticosteroids within 2 months prior to randomisation.
4.Corticosteroids used for inhalation within 1 month prior to randomisation.
5.Use of any antibiotics within 1 month prior to randomisation.
6.Immunosuppressive treatment received within 1 month prior to randomisation.
7.Treatment with omalizumab (Xolair) within 1 year prior to randomization.
8.Allergy vaccination therapy (desensitisation immunotherapy) within 10 years prior to randomization.
9.Any other vaccination received within 3 months prior to randomisation or scheduled to receive vaccination during the first 20 weeks of the study.

Other medical history
10.History or evidence of significant cardiovascular, renal, hepatic or endocrine disease
11.Other clinical significant findings regarding health status as judged by medical history, physical examination, ECG, vital signs, clinical chemistry/hematology/urinalysis that may interfere with the study treatment.
12.Positive test for human immunodeficiency virus (HIV), Hepatitis B surface antigen tests and/or antibodies to Hepatitis C virus. (The patient should have been tested within 3 months prior to randomization.)

Other
13.Treatment with an investigational drug within 2 months prior to randomization
14.Current alcohol or drug abuse
15.Donation of blood, exceeding 450 ml, during the 3 months prior to the first administration of the investigational product.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective is to compare two different formulations of RP 01 in terms of safety, tolerability and efficacy. This will be assessed by adverse events (AEs), laboratory safety variables, expression of FceRI on blood basophiles and the specific immune response markers IgG anti-IgE and IgG anti-OSO.;Main Objective: The primary objective is to establish the maximum tolerable effective dose of RP 01 as an anti-IgE immunotherapy in allergic patients. Adverse events (AEs), laboratory safety variables and the specific immune response markers IgG anti-IgE and IgG anti-OSO will be assessed. ;Primary end point(s): Efficacy assessments included in the study are based on various specific immune response markers:<br>-Induction of IgG anti-OSO antibodies and IgG anti-IgE antibodies.<br>-Expression of FceRI on blood basophils.<br>-Induction of IgE neutralizing antibodies<br>-Levels of total IgE and free IgE.<br>-Basophil activation.<br>Bullets 3-5 represents exploratory variables.<br>