Subcutaneous Immunotherapy for Mouse in Adults

NCT02532179 | Completed Phase 1 Results DMC

• 1 other identifier: DAIT ICAC-26
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (2)

• Number of Reported Adverse Events (AEs)

  Frequency of any AEs tabulated by preferred event term.

  Baseline (Pre-Treatment) through 24 Weeks of Treatment

• Number of Reported Serious Adverse Events (SAEs)

  Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation.

  Baseline (Pre-Treatment) through 24 Weeks of Treatment

Secondary Outcomes (4)

• Change in Mouse-Specific IgE Antibodies

  Baseline (Pre-Treatment) through Week 24

• Change in Mouse-Specific IgG Antibodies

  Baseline (Pre-Treatment) to Week 24

• Change in Mouse-Specific IgG4 Antibodies

  Baseline (Pre-Treatment) to Week 24

• Change in In-vitro Mouse Antigen Binding to B-cells

  Baseline (Pre-Treatment) to Week 24

Study Arms (1)

Mouse Allergenic Extract

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.

Biological: Mouse Allergenic Extract

Interventions

Mouse Allergenic Extract 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.

Also known as: mouse epithelial extract, allergenic extract of Mus musculus

Mouse Allergenic Extract

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Inner-City Asthma Consortium: collaborator

Study Sites (4)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Ann and Robert Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

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

Baltimore, Maryland, 21287, United States

Location

Henry Ford Health System: Division of Allergy and Immunology

Detroit, Michigan, 48202, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• History, project and sites of the Inner-city Asthma Consortium (ICAC)
• Information: National Asthma Education and Prevention Program (NAEPP)

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic, Perennial

Interventions

Urea

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Robert Wood, M.D.

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 7, 2018
• Results First Posted: November 28, 2017

Record last verified: 2018-02

Locations

US (4)