A double-blind, randomised, placebo controlled, phase I/IIa dose escalation study to investigate the safety and tolerability of Oralgen Birch Pollen immunotherapy in patients with allergic rhinoconjunctivitis

Conditions: Allergic rhinoconjunctivitis
MedDRA version: 9.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis

Registration Number: EUCTR2008-003861-17-SE

Lead Sponsor: Artu Biologicals Europe B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Male and female between 18 and 60 years of age (inclusive).
- History of birch pollen induced allergy with moderate to severe rhinoconjunctivitis symptoms for at least two seasons.
- RRTSS of greater than or equal to 10 out of a maximal score of 18
- Birch pollen specific RAST of at least class 2.
- Positive skin prick test (i.e. wheal diameter equal to or more than (=) 3 mm larger than the diluent control) for birch pollen.
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

- Other clinically relevant allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments. Patients with allergic rhinoconjunctivitis due to allergens to which the patient is not exposed to during the study are allowed into the study.
- Use of oral steroids within 12 weeks before the screening visit.
- Treatment with beta-blockers or continuous inhalsed or systemic corticosteroid therapy.
- Previous immunotherapy treatment with tree pollen extracts within the last five years or immunotherapy with any other allergen extract within the last two years.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety and tolerability of Oralgen Birch Pollen in patients with allergic rhinoconjunctivitis.;Secondary Objective: ;Primary end point(s): safety and tolerability assessed as adverse events, hematology and biochemistry laboratory parameters, urinalysis, 12-Lead ECG, vital signs (blood pressure, pulse and respiration rate) and physical examination.

Secondary Outcome Measures