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

Biomay

Status and phase: Completed; Phase 2

Conditions: Grass Pollen Allergy

Treatments: Biological: Placebo; Biological: BM32

Study type: Interventional

Funder types: Industry

Identifiers

NCT01445002

CS-BM32-002

2011-003368-64 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 4 patient groups, including a placebo group

BM32 low dose

Experimental group

Description:

3 subcutaneous injections of 10 micrograms in a time span of 8 weeks

Treatment:

Biological: BM32

Biological: BM32

Biological: BM32

BM32 medium dose

Experimental group

Description:

3 subcutaneous injections of 20 micrograms in a time span of 8 weeks

Treatment:

Biological: BM32

Biological: BM32

Biological: BM32

BM32 high dose

Experimental group

Description:

3 subcutaneous injections of BM32 over a time span of 8 weeks

Treatment:

Biological: BM32

Biological: BM32

Biological: BM32

Placebo

Placebo Comparator group

Description:

3 subcutaneous injections over a time span of 8 weeks

Treatment:

Biological: Placebo