NCT02532179

Subcutaneous Immunotherapy for Mouse in Adults

A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Asthma
• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	Mouse Allergenic Extract	Subjects will receive escalating doses of glycerinated mouse allergenic extract administered subcutaneously up to a maximum study dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol., per protocol.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-08-25
• Last updated: 2018-03-07
• Results posted: 2017-11-28

Locations

4 sites across 1 country: United States