Subcutaneous Immunotherapy for Mouse in Adults

NCT ID: NCT02532179

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-10-31

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).

Conditions

Asthma; Perennial Allergic Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mouse Allergenic Extract

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

mouse epithelial extract; allergenic extract of Mus musculus

Eligibility Criteria

Inclusion Criteria

Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participants are ineligible if they:

• Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
• Cannot perform spirometry at Screening;
• Have an asthma severity classification at Recruitment of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:

• Requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid;
• Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months;
• Have been treated with depot steroids within the last 12 months;
• Have been hospitalized for asthma within the 6 months prior to recruitment;
• Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment.
• Do not have access to a phone (needed for scheduling appointments);
• Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study;
• Have previously been treated with anti-IgE therapy within 1 year of recruitment;
• Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study;
• Refuses to sign the Epinephrine Auto-injector Training Form.

Exclusion Criteria

Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:

• Do not primarily speak English;
• Plan to move from the area during the study period;
• Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined per protocol;
• Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant;
• Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical);
• Have not received the seasonal Flu (Influenza) Vaccine if enrolling December through March.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inner-City Asthma Consortium

NETWORK

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Wood, M.D.

Role: STUDY_CHAIR

Johns Hopkins Children's Center: Department of Allergy & Immunology

Locations

Children's National Health System

Washington D.C., District of Columbia, United States

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/clinical-trials/inner-city-asthma-consortium

History, project and sites of the Inner-city Asthma Consortium (ICAC)

http://www.nhlbi.nih.gov/about/org/naepp

Information: National Asthma Education and Prevention Program (NAEPP)

Other Identifiers

DAIT ICAC-26

Identifier Type: -

Identifier Source: org_study_id