A randomised, double-blind, placebo-controlled, long-term Phase III study to assess the efficacy and safety of Oralgen® Grass Pollen in patients with grass pollen-related allergic rhinoconjunctivitis.
- Conditions
- Allergic Rhinoconjunctivitis due to grass pollen allergy.MedDRA version: 9.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis
- Registration Number
- EUCTR2008-004825-40-NL
- Lead Sponsor
- Artu Biologicals Europe BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Male or female patients aged 18 to 55 years (inclusive).
2. Grass pollen-related allergic rhinoconjunctivitis symptoms for at least the last 2 pollen seasons.
3. Positive skin prick test (wheal diameter more than 3 mm larger than the diluent control) and a grass pollen specific IgE value of at least Class II.
4. RRTSS of greater than or equal to 12 (maximum score 18) during the 2008 pollen season.
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
1. Positive skin prick test for environmental allergens such as house dust mites and cockroaches, and suffering from serious allergic symptoms due to exposure to these allergens during the study period.
2. A clinical history of significant symptomatic seasonal allergic rhinitis and / or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping, the grass pollen season.
3. A clinical history of significant symptomatic perennial allergic rhinitis and / or asthma caused by an allergen to which the patient is regularly exposed.
4. Patients who lack general good health as determined by past medical history, physical examination, 12-lead ECG and safety laboratory tests.
5. Abnormal spirometry: Forced Expiratory Volume in 1 second (FEV1) at least 80% of the predicted value at screening.
6. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included.
7. Use of oral steroids within 12 weeks before the screening visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term efficacy of 19,000 BU Oralgen® Grass Pollen administered daily in patients with grass pollen-related allergic rhinoconjunctivitis;Secondary Objective: To assess the long-term safety and tolerability of 19,000 BU Oralgen® Grass Pollen administered daily in patients with grass pollen-related allergic rhinoconjunctivitis;Primary end point(s): For final analysis: Difference between active and placebo during season 3 in centre-specific pollen season combined RTSS/RMS score.<br><br>For interim analysis: Difference between active and placebo during season 1 and 2, respectively, in centre-specific pollen season combined RTSS/RMS score<br><br>RTSS/RMS score: the combined score consisting of pollen season Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS)
- Secondary Outcome Measures
Name Time Method