Study of rBet v1 Tablets

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00901914
• Date of registration: 28/04/2009
• Prospective Registration: No
• Primary sponsor: Stallergenes
• Public title: Study of rBet v1 Tablets
• Scientific title: A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis
• Date of first enrolment: October 2008
• Target sample size: 483
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00901914
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Denmark, Finland, France, Germany, Lithuania, Poland, Russian Federation, Sweden

Contacts

• Name: Sabina Rak, MD. PR
• Affiliation: Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2
pollen seasons

- Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to
birch pollen with wheal diameter greater than 3 mm and specific IgE levels > 0.70
kU/L (birch pollen and rBet v 1)

- Patients asymptomatic to all other allergens during the birch pollen season

- RRTSS during the previous pollen season = 12 out of a maximum possible score of 18

- Patients with an FEV1 = 80% of the predicted value

- Female patients with no childbearing potential

- Female patients of childbearing potential are eligible if they are not sexually
active or if they use a medically accepted contraceptive method and have a negative
urine pregnancy test, and are willing and able to sign written informed consent
stating that they will use appropriate contraception and not plan a pregnancy during
this study

- Patients able to be compliant with respect to the completion of the daily record card
and taking of the investigational products

- Patients having provided signed informed consent

Exclusion Criteria:

- Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to
non-birch-related allergens

- Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust
mites

- Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog
allergens, and living with these animals at home or at risk of frequent contacts with
these animals (family, friends etc.) during the course of the study

- Patients who previously received desensitisation treatment to birch pollen and/or
another Betulaceae sp. within the previous 10 years

- Patients with asthma (except birch seasonal asthma in which case the patient could be
included in the study)

- Patients with any nasal or oral condition that could interfere with efficacy or
safety assessments (such as nasal polyposis or oral inflammation)

- Patients with a past or current disease, which as judged by the investigator, may
affect the patient's participation in or outcome of this study

- Any disease or condition which would place a patient at undue risk by being included
in the study (according to the investigator's opinion)

- Usual contra-indications of immunotherapy such as concomitant local or systemic
beta-blocker therapy and/or immunosuppressive drugs

- Patients with ongoing treatment by immunotherapy with another allergen

- Patients treated with inhaled/systemic steroids within 4 weeks prior to Screening, or
with long acting systemic corticosteroids 12 weeks before Screening

- Patients under continuous corticotherapy or undergoing chronic treatment with
H2-antihistamine drugs

- Known hypersensitivity to mannitol

- Pregnancy, breast-feeding/lactation or sexually active women of childbearing
potential who are not using a medically accepted contraceptive method

- Patients with a history of drug or alcohol abuse



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rhinitis, Allergic, Seasonal

Birch Pollen-related Rhinoconjunctivitis

Intervention(s)

Biological: Placebo

Biological: rBet v 1

Primary Outcome(s)

Average Adjusted Symptom Score [Time Frame: ~1 month (whole birch pollen season)]

Secondary Outcome(s)

Average Combined Score [Time Frame: ~1 month (whole birch pollen season)]

Safety assessments [Time Frame: 6-7 months]

Immunological markers (IgE and IgG4) [Time Frame: 6-7 months]

Proportion of symptom-controlled days [Time Frame: ~1 month (whole birch pollen season)]

Average Rhinoconjunctivitis Total symptom Score [Time Frame: ~1 month (whole birch pollen season)]

Lower airways symptoms [Time Frame: ~1 month (whole birch pollen season)]

Global evaluation by the patient [Time Frame: after 5-6 months of treatment]

Sensitisation status [Time Frame: At least 6 months]

Rescue Medication Score [Time Frame: ~1 month (whole birch pollen season)]

Secondary ID(s)

2007-007869-21

VO59.08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Quintiles

Aptuit Inc.