Study of rBet v1 Tablets

Rhinitis, Allergic, Seasonal Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901914
• Other study ID #: VO59.08
• Secondary ID: 2007-007869-21
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: June 26, 2013
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyPoland: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Lithuania: State Medicine Control Agency - Ministry of HealthRussia: Ministry of Health of the Russian FederationSweden: Medical Products AgencyDenmark: Danish Medicines AgencyGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birch Pollen-related Rhinoconjunctivitis
• Conjunctivitis
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• Placebo
One sublingual tablet of matching placebo daily during approximately 5.5 months
• rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
• rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
• rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months

Locations

Country	Name	City	State
Denmark	National University Hospital - Allergy Unit 4222	Copenhagen
Finland	Helsingin yliopistollinen keskussairaala	Helsinki
France	NHC, Hôpitaux Universitaires de Strasbourg	Strasbourg
Germany	Charité universitaetsmedizin	Berlin
Lithuania	Public Institution Kaunas Medical University Hospital	Kaunas
Poland	SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Lodzi	Lodz
Russian Federation	Institute of Immunology of FMBA	Moscow
Sweden	Sabina RAK	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Stallergenes	Aptuit Inc., Quintiles, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Adjusted Symptom Score		~1 month (whole birch pollen season)	No
Secondary	Average Rhinoconjunctivitis Total symptom Score		~1 month (whole birch pollen season)	No
Secondary	Rescue Medication Score		~1 month (whole birch pollen season)	No
Secondary	Average Combined Score		~1 month (whole birch pollen season)	No
Secondary	Proportion of symptom-controlled days		~1 month (whole birch pollen season)	No
Secondary	Global evaluation by the patient		after 5-6 months of treatment	No
Secondary	Immunological markers (IgE and IgG4)		6-7 months	No
Secondary	Sensitisation status		At least 6 months	No
Secondary	Lower airways symptoms		~1 month (whole birch pollen season)	No
Secondary	Safety assessments		6-7 months	Yes