Overview

This trial has been completed.

Conditions asthma, perennial allergic rhinitis
Treatment mouse allergenic extract
Phase phase 1/phase 2
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Inner-City Asthma Consortium
Start date October 2015
End date October 2016
Trial size 50 participants
Trial identifier NCT02532179, DAIT ICAC-26

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
mouse allergenic extract mouse epithelial 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.

Primary Outcomes

Measure
Number of Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline through 24 weeks of treatment

Secondary Outcomes

Measure
Change in Mouse Specific IgE
time frame: Baseline to Week 24
Change in Mouse Specific IgG and IgG4
time frame: Baseline to Week 24
Change in Mouse Prick Skin Test Wheal
time frame: Baseline to Week 24

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).