A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00812799
• Date of registration: 19/12/2008
• Prospective Registration: No
• Primary sponsor: Artu Biologicals
• Public title: A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis
• Scientific 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
• Date of first enrolment: December 2008
• Target sample size: 374
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00812799
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, France, Germany, Netherlands, Poland, United Kingdom

Contacts

• Name: Folkert Roossien
• Affiliation: Artu-Biologicals Europe B.V.

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Allergic Rhinoconjunctivitis

Intervention(s)

Other: placebo control

Drug: Oralgen

Primary Outcome(s)

Difference between active and placebo-group based on combined RTSS and RMS score [Time Frame: third season]

Secondary Outcome(s)

Difference between active and placebo based on RTSS score [Time Frame: third season]

Secondary ID(s)

AB0801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors