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

Artu Biologicals Europe B.V.0 个研究点开始时间: 2008年6月24日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Artu Biologicals Europe B.V.