Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy

Phase 2

Completed

• Conditions: Grass Pollen Allergy
• Interventions: Biological: BM32; Biological: Placebo

• Registration Number: NCT01445002
• Lead Sponsor: Biomay AG

Brief Summary

The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:

* skin prick testing

* grass pollen inhalation challenge

* antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-30
• Study Start: 2011-10
• Study First Posted: 2011-10-03
• Primary Completion: 2012-03
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• History of seasonal allergic rhinitis from grass pollen
• Normal electrocardiogram
• Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
• Positive skin prick test for grass pollen at or within 12 months preceding screening visit
• Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit

Exclusion Criteria

• Pregnant or lactating females
• Females with childbearing potential not using medically acceptable birth control
• Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
• Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
• Current or recent participation in another clinical trial
• SIT for grass pollen allergy in the last two years prior to study
• Past or present disease, which may affect outcome of the trial, judged by investigator
• Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies
• Suspected hypersensitivity to any ingredients of study medication
• Use of prohibited medication prior to screening and throughout study
• depot corticosteroids (12 weeks)
• oral corticosteroids (8 weeks)
• inhaled corticosteroids (4 weeks)
• Allergic symptoms at the time of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BM32 high dose	BM32	3 subcutaneous injections of BM32 over a time span of 8 weeks
Placebo	Placebo	3 subcutaneous injections over a time span of 8 weeks
BM32 low dose	BM32	3 subcutaneous injections of 10 micrograms in a time span of 8 weeks
BM32 medium dose	BM32	3 subcutaneous injections of 20 micrograms in a time span of 8 weeks

Primary Outcome Measures

Name	Time	Method
Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen	Baseline and 14 weeks	Difference in the total Nasal Symptom Score (TNSS) between spending 6 hrs in the Vienna Challenge Chamber (VCC) at screening and spending 6 hrs in the VCC four weeks after the last subcutaneous injection of BM32.

Secondary Outcome Measures

Name	Time	Method
Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen	Baseline and 14 weeks
Minimum effective dose for reduction of Global symptom Score upon inhalation challenge with grass pollen	Baseline and 4 weeks after final s.c. injection
Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen	Baseline and 14 weeks
Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing	Baseline and 14 weeks
Difference in FEV1 and FEV/FVC between screening and completion of vaccination	Baseline and 14 weeks
Frequency of local reactions to treatment	average of 8 weeks from 1st to last injection
Change in allergy specific total IgG	Baseline and average of 12 weeks after randomization
Change in allergy specific IgE	Baseline and average of 12 weeks after randomization
Frequency of systemic reactions to treatment	average of 8 weeks from 1st to last injection
Severity of local reactions to treatment	Average of 8 weeks from 1st to last injection
Severity of systemic reactions to treatment	Average of 8 weeks from 1st to last injection
Frequency of adverse events	average of 14 weeks from 1st injection

Trial Locations

Locations (1)

Allergy Center Vienna West; 🇦🇹 Vienna, Austria