Subcutaneous Immunotherapy for Mouse in Adults

Phase 1

Completed

• Conditions: Asthma; Perennial Allergic Rhinitis
• Interventions: Biological: Mouse Allergenic Extract

• Registration Number: NCT02532179
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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).

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-25
• Study Start: 2015-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-10-30
• Results First Submitted QC: 2017-11-27
• Results First Posted: 2017-11-28
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mouse Allergenic Extract	Mouse Allergenic Extract	Participants will receive escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol.

Primary Outcome Measures

Name	Time	Method
Number of Reported Serious Adverse Events (SAEs)	Baseline (Pre-Treatment) through 24 Weeks of Treatment	Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation.
Number of Reported Adverse Events (AEs)	Baseline (Pre-Treatment) through 24 Weeks of Treatment	Frequency of any AEs tabulated by preferred event term.

Secondary Outcome Measures

Name	Time	Method
Change in Mouse-Specific IgG4 Antibodies	Baseline (Pre-Treatment) to Week 24	Serum Immunoglobulin G4 (IgG4) is a subtype of antibody produced by the immune system. If a participant has bacterial or viral infections, the immune system will respond to that particular infection by producing IgG4 antibodies.; This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgG4 versus post-baseline mouse-specific serum IgG4. The numerator is the geometric mean post-baseline IgG4 and, the denominator is the baseline IgG4. A ratio of greater than 1 would indicate an increase in IgG4 antibodies throughout the course of the study.
Change in Mouse-Specific IgE Antibodies	Baseline (Pre-Treatment) through Week 24	Serum Immunoglobulin E (IgE) is an antibody produced by the immune system. If a participant has an allergy, the immune system will respond to that particular allergen by producing IgE antibodies. These antibodies travel to cells that release chemicals, causing allergic reactions.; This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgE versus post-baseline mouse-specific serum IgE. The numerator is the geometric mean post-baseline IgE and the denominator is baseline IgE. A ratio of greater than 1 would indicate an increase in IgE throughout the course of the study.
Change in Mouse-Specific IgG Antibodies	Baseline (Pre-Treatment) to Week 24	Serum Immunoglobulin G (IgG) is an antibody produced by the immune system. If a participant has bacterial or viral infections, the immune system will respond to that particular infection by producing IgG antibodies.; This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgG versus post-baseline mouse-specific serum IgG. The numerator is the geometric mean post-baseline IgG and, the denominator is the baseline IgG. A ratio of greater than 1 would indicate an increase in IgG throughout the course of the study.
Change in In-vitro Mouse Antigen Binding to B-cells	Baseline (Pre-Treatment) to Week 24	The plan was to analyze serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants to determine if treatment inhibits in-vitro mouse antigen binding to B-cells after 6-months of treatment with mouse SCIT, using the per protocol allergenic extract doses. However, the Sponsor cancelled pursuit of mouse immunotherapy within its program at this time due to assay development complexities and cost; thus, there are no analyses/results for this endpoint/outcome.

Trial Locations

Locations (4)

Ann and Robert Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Children's Center: Department of Allergy & Immunology; 🇺🇸 Baltimore, Maryland, United States

Henry Ford Health System: Division of Allergy and Immunology; 🇺🇸 Detroit, Michigan, United States

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States