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| Name | Class |
|---|---|
| Inner-City Asthma Consortium | NETWORK |
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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mouse-Specific IgE Antibodies | 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wood, M.D. | Johns Hopkins Children's Center: Department of Allergy & Immunology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Health System | Washington D.C. | District of Columbia | 20010 | United States | ||
| Ann and Robert Lurie Children's Hospital of Chicago |
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| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| History, project and sites of the Inner-city Asthma Consortium (ICAC) | View source |
| Information: National Asthma Education and Prevention Program (NAEPP) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mouse Allergenic Extract | Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician's discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mouse Allergenic Extract | Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician's discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Reported Adverse Events (AEs) | Frequency of any AEs tabulated by preferred event term. | Intent-to-treat | Posted | Number | Events | Baseline (Pre-Treatment) through 24 Weeks of Treatment |
|
Enrollment through end of study (up to 24 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mouse Allergenic Extract | Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 w/v glycerinated mouse allergenic extract, with proceeding administration of additional dosage at study clinician's discretion, for up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation would continue until maximum study dose is achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants would receive one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site swelling | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2016 | Oct 25, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D014508 | Urea |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Baseline (Pre-Treatment) through Week 24 |
| Change in Mouse-Specific IgG Antibodies | 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. | Baseline (Pre-Treatment) to Week 24 |
| Change in Mouse-Specific IgG4 Antibodies | 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. | Baseline (Pre-Treatment) to Week 24 |
| Change in In-vitro Mouse Antigen Binding to B-cells | 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. | Baseline (Pre-Treatment) to Week 24 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Johns Hopkins Children's Center: Department of Allergy & Immunology | Baltimore | Maryland | 21287 | United States |
| Henry Ford Health System: Division of Allergy and Immunology | Detroit | Michigan | 48202 | United States |
| View source |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mouse-Specific Serum Immunoglobulin E (IgE) Levels | 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 antibodies called IgE. These antibodies travel to cells that release chemicals, which cause allergic reactions. We collect mouse-specific serum IgE at baseline and compare with post-baseline IgE in order to determine immune modulation over time. The higher the IgE present in the serum sample, the more likely there is to be a presence of a clinical allergy to the mouse allergen. | Geometric Least Squares Mean | Standard Deviation | kU/L |
|
| Mouse-Specific Serum Immunoglobulin G (IgG) Levels | 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 antibodies called IgG. We collect mouse-specific serum IgG at baseline and compare with post-baseline IgG in order to determine immune modulation over time. The higher the IgG present in the serum sample, the more likely there is to be a presence of a clinical allergy to the mouse allergen. | Geometric Least Squares Mean | Standard Deviation | kU/L |
|
| Mouse-Specific Serum Immunoglobulin G4 (IgG4) Levels | Serum Immunoglobulin G4 (IgG4) is a certain 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 antibodies called IgG4. We collect mouse-specific serum IgG4 at baseline and compare with post-baseline IgG4 in order to determine immune modulation over time. The higher the IgG4 present in the serum sample, the more likely there is to be a presence of a clinical allergy to the mouse allergen. | Geometric Least Squares Mean | Standard Deviation | kU/L |
|
|
|
| Primary | Number of Reported Serious Adverse Events (SAEs) | Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation. | Intent-to-treat | Posted | Number | Number of SAEs | Baseline (Pre-Treatment) through 24 Weeks of Treatment |
|
|
|
| Secondary | Change in Mouse-Specific IgE Antibodies | 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. | Intent-to-treat | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Ratio | Baseline (Pre-Treatment) through Week 24 |
|
|
|
|
| Secondary | Change in Mouse-Specific IgG Antibodies | 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. | Intent-to-treat | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Ratio | Baseline (Pre-Treatment) to Week 24 |
|
|
|
|
| Secondary | Change in Mouse-Specific IgG4 Antibodies | 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. | Intent-to-treat | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Ratio | Baseline (Pre-Treatment) to Week 24 |
|
|
|
|
| Secondary | Change in In-vitro Mouse Antigen Binding to B-cells | 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. | No analysis conducted: Sponsor's decision to not pursue assay development in this study. | Posted | Baseline (Pre-Treatment) to Week 24 |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Peak expiratory flow rate decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |