Study of rBet v1 Tablets

NCT00901914 | Completed Phase 2

• 2 other identifiers: VO59.082007-007869-21
• Study Type: interventional
• Target: 483
• Locations: 8 countries
• Sites: 8

Brief 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.

Conditions

Birch Pollen-related Rhinoconjunctivitis; Rhinitis, Allergic, Seasonal

Keywords

Hypersensitivity; Allergy; Birch, allergy, Sublingual Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Average Adjusted Symptom Score

  ~1 month (whole birch pollen season)

Secondary Outcomes (9)

• Average Rhinoconjunctivitis Total symptom Score

  ~1 month (whole birch pollen season)

• Rescue Medication Score

  ~1 month (whole birch pollen season)

• Average Combined Score

  ~1 month (whole birch pollen season)

• Proportion of symptom-controlled days

  ~1 month (whole birch pollen season)

• Global evaluation by the patient

  after 5-6 months of treatment

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo

Biological: Placebo

2

EXPERIMENTAL

12.5 µg rBet v 1

Biological: rBet v 1

3

EXPERIMENTAL

25 µg rBet v 1

Biological: rBet v 1

4

EXPERIMENTAL

50 µg rBet v 1

Biological: rBet v 1

Interventions

Placebo BIOLOGICAL

One sublingual tablet of matching placebo daily during approximately 5.5 months

Also known as: Placebo control

1

rBet v 1 BIOLOGICAL

One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months

Also known as: rBet v 1.0101

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stallergenes Greer: lead
• Quintiles, Inc.: collaborator
• Aptuit: collaborator

Study Sites (8)

National University Hospital - Allergy Unit 4222

Copenhagen, 2100, Denmark

Location

Helsingin yliopistollinen keskussairaala

Helsinki, 00029, Finland

Location

NHC, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Charité universitaetsmedizin

Berlin, 10117, Germany

Location

Public Institution Kaunas Medical University Hospital

Kaunas, 50009, Lithuania

Location

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi

Lodz, 90-153, Poland

Location

Institute of Immunology of FMBA

Moscow, 115478, Russia

Location

Sabina RAK

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Sabina Rak, MD. PR

  Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: May 14, 2009
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 27, 2013

Record last verified: 2010-02

Locations

DE (1); LI (1); PL (1); FI (1); RU (1); FR (1); DK (1); SE (1)