This trial is active, not recruiting.

Condition allergic rhinoconjunctivitis
Treatments oralgen, placebo control
Phase phase 3
Sponsor Artu Biologicals
Start date December 2008
End date August 2011
Trial size 374 participants
Trial identifier NCT00812799, AB0801


This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
Subjects will receive 19.000 BU grass pollen extract daily sublingually
oralgen Grass pollen extract
19.000 BU daily
(Placebo Comparator)
Subjects will receive matching placebo control daily sublingually
placebo control placebo control
placebo control

Primary Outcomes

Difference between active and placebo-group based on combined RTSS and RMS score
time frame: third season

Secondary Outcomes

Difference between active and placebo based on RTSS score
time frame: third season

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - male or female - grass pollen related rhinoconjunctivitis symptoms for at least the last 2 pollen seasons - positive skin prick test RRTSS greater or equal to 12 during the 2008 season - signed informed consent Exclusion Criteria: - positive skin prick test for other environmental allergens and suffering from serious allergic symptoms - clinical history of significant symptomatic allergic rhinitis due to tree/weed pollen which potentially overlap the grass pollen season - clinical history of symptomatic perennial allergic rhinitis caused by an allergen to which the patient is regularly exposed - lacking of good health - abnormal spirometry - lower respiratory tract infection - asthma requiring treatment other than beta-2 agonists - oral steroids within 12 weeks before screening - regular contraindications for use of immunotherapy

Additional Information

Official title 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
Description Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by Artu Biologicals.