Clinical trial NCT02532179: Subcutaneous Immunotherapy for Mouse in Adults
Official title: A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Asthma
Perennial Allergic Rhinitis
Keywords: subcutaneous immunotherapy (SCIT)
glycerinated mouse allergenic extract
mouse specific IgE
mouse specific IgG and IgG4
mouse prick skin test wheal
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Inner-City Asthma Consortium
First posted: 2015-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Reported Adverse Events (AEs)
timeFrame: Baseline (Pre-Treatment) through 24 Weeks of Treatment
measure: Number of Reported Serious Adverse Events (SAEs)
timeFrame: Baseline (Pre-Treatment) through 24 Weeks of Treatment
Secondary outcomes:
measure: Change in Mouse-Specific IgE Antibodies
timeFrame: Baseline (Pre-Treatment) through Week 24
measure: Change in Mouse-Specific IgG Antibodies
timeFrame: Baseline (Pre-Treatment) to Week 24
measure: Change in Mouse-Specific IgG4 Antibodies
timeFrame: Baseline (Pre-Treatment) to Week 24
measure: Change in In-vitro Mouse Antigen Binding to B-cells
timeFrame: Baseline (Pre-Treatment) to Week 24
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Chicago
country: United States
facility: Ann and Robert Lurie Children's Hospital of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center: Department of Allergy & Immunology
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System: Division of Allergy and Immunology
state: Michigan
Study officials:
affiliation: Johns Hopkins Children's Center: Department of Allergy & Immunology
name: Robert Wood, M.D.
role: STUDY_CHAIR
References: