Asthma Clinical Trial
Official title:
A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)
This is an open label trial of mouse allergenic extract administered by subcutaneous
injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:
- the safety of this therapy when given by injection
- biomarkers of the immune response and
- whether the therapy would be effective in treating allergic asthma.
The primary objective of the study is to assess if treatment with mouse subcutaneous
immunotherapy (SCIT), using the per protocol allergenic extract doses, is safe. This will be
done by determining the rate of related adverse events and serious adverse events in the
course of treatment.
Secondary objectives include:
- determination of whether a 24 week treatment with mouse SCIT, using the per protocol
allergenic extract doses, will induce a 3-fold increase in mouse-specific serum
immunoglobulin E (IgE)
- determination of whether a 24 week treatment with mouse SCIT, using the per protocol
allergenic extract doses, will induce changes in the serum levels of mouse-specific
immunoglobulin G (IgG) and immunoglobulin subclass 4 (IgG4).
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