Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal … (NCT01490411) | Clinical Trial Compass
CompletedPhase 2
Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis
Germany37 participantsStarted 2010-10
Plain-language summary
The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is a vaccine that works by exposing your immune system to something that resembles birch. This vaccine may help to lessen your allergy symptoms during the natural birch season.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
Patients must meet all of the following to be eligible for enrollment:
* Is a male or female, aged 18 to 65 years, inclusive.
* Has a clinical history of allergic rhinitis to birch pollen at least during each of the last 2 years.
* Has a birch pollen specific IgE result (EAST) greater than 0.75 kU/L on blood sample drawn at Visit 1.
* Has a positive skin prick test to birch allergen(s) at Visit 1, with a wheal diameter of at least 4 mm.
* Has minimum qualifying symptom scores at Visit 2.
* Patients with sensitization to cat epithelia, dog epithelia, Dermatophagoides farinae or Dermatophagoides pteronyssinus as per the skin prick test and/or EAST, may be included if sensitization is not clinically relevant.
* Meets the concomitant medication restrictions described in the protocol.
* Is normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.
* Is willing and able to give signed informed consent, and must have provided this consent.
* Is willing and able to attend required study visits.
Exclusion Criteria:
A patient will not be included in this study if any of the following criteria apply:
For female subjects:
* Female subjects with childbearing potential (i.e., females are not chemically or surgically sterilised or females who are not post-menopausal) with a positive pregnancy test at Visit 1.
* Female subjects with a negative pregnancy test at enrolment and not willi…
What they're measuring
1
Relative efficacy of four different doses compared to placebo.