Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI114271 | U.S. NIH Grant/Contract | View source | |
| NIAID CRMS ID#: 38517 | Other Identifier | DAIT NIAID |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Inner-City Asthma Consortium | NETWORK |
| Rho Federal Systems Division, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Scientific evidence has shown that, over the past two decades, the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma.
The primary objective of the study is to determine if the response to nasal allergen challenge (NAC) will be changed with treatment with cockroach subcutaneous immunotherapy (SCIT) treatment.
This is a 1:1 randomized, double-masked (blind), placebo-controlled, multicenter trial with 2 treatment arms:
Eighty participants 8 to 17 years of age who are sensitized to cockroach, have asthma, and a positive cockroach Nasal Allergen Challenge (NAC) before treatment randomization will be enrolled.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G. cockroach allergenic extract | Experimental | Subcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm. -Up to 2 doses of the assigned SCIT treatment will be given weekly during dose escalation, separated by a minimum of 2 days. After maintenance dose is achieved, participants will receive three maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. |
|
| Placebo | Placebo Comparator | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 14 years of age will be randomized to this treatment arm. -Up to 2 doses of the assigned SCIT treatment will be given weekly during dose escalation, separated by a minimum of 2 days. Once the maintenance dose is achieved, participants will receive three maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| German cockroach allergenic extract | Biological | Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo | The study's primary endpoint is the mean TNSS change from baseline to 12 months, calculated as the difference between baseline and 12-month mean TNSS up to baseline responsive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling mean TNSS difference with factors for treatment arm, site, and baseline mean TNSS. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome. | After 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Immunotherapy Related Adverse Events and Number of Immunotherapy Related Serious Adverse Events in the Course of Treatment. | Summary tables will present the total number of Immunotherapy related adverse event within the course of treatment. | After 12 months |
| Change in Area Under the Curve (AUC) Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| EXPLORATORY: Composite Asthma Severity Score (CASI)-by Treatment Group | The Composite Asthma Severity Index (CASI) is a comprehensive severity scale combining multiple facets of asthma severity: impairment, risk, and treatment. The CASI score ranges from 0 to 20 points, with higher scores indicating higher levels of severity, and includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. |
Inclusion Criteria:Subject(s)
And/or parent guardian must be able to understand and provide informed consent;
Age at date of recruitment (e.g., screening): 8 to 17 years of age
Have a primary place of residence in one of the pre-selected recruitment census tracts (Reference: Inner-City Asthma Consortium):
--Note: Subjects who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly-funded health insurance will qualify for inclusion.
Have a history of persistent asthma, for a minimum of 1 year before study entry:
At the time of randomization, the subject's asthma must be well controlled as defined by:
Is sensitive to German cockroach as documented by:
Have no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo;
Have a positive cockroach nasal challenge, as defined by reaching a Total Nasal Symptom Score (TNSS) of ≥6 or a sneezing score of 3 at dose 2 or above during the challenge before randomization; and
Have documentation of current medical insurance with prescription coverage at randomization.
Exclusion Criteria:Subject(s)
Unable or unwilling to give written informed consent or comply with the study protocol;
That is pregnant or lactating;
That are post-menarcheal females must be abstinent or use a medically acceptable birth control method throughout their participation in the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
That cannot perform spirometry and peak flow at treatment randomization;
That have an asthma severity classification at the time of treatment randomization of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
Does not have access to a phone (needed for scheduling appointments);
Has received allergen immunotherapy (Sublingual Immunotherapy [SLIT] or Subcutaneous Immunotherapy [SCIT]) in the last 12 months or, who plan to initiate or resume allergen immunotherapy during the study;
Has received biologic therapy (e.g., anti-Immunoglobulin E [IgE], anti-IL-4, anti-IL-5) within 6 months of study entry;
Has received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study;
Has past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may:
Who have nasal polyps or other major structural abnormalities in their nasal cavities as assessed by anterior rhinoscopy,
Who meet any of the following criteria are not eligible for enrollment and may not be reassessed:
That plan to move from the area during the study period,
Have a history of anaphylaxis grade 3 or higher as defined by World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System,
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 product or pose additional risk to the subject,
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator,
Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Wood, MD | Johns Hopkins Children's Center: Department of Allergy & Immunology | Study Chair |
| Edward M. Zoratti, MD | Henry Ford Health System: Division of Allergy and Immunology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Children's National Medical Center - IMPACT DC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42006155 | Derived | Dunaway LE, Da Silva Antunes R, Pomes A, Altman MC, Glesner J, Benson B, Cho K, Zoratti EM, Wood RA, Little FF, Pongracic JA, Hershey GKK, Sherenian MG, Chambliss JM, Gill MA, Liu AH, Lamm C, Kattan M, Bacharier LB, Sheehan WJ, Busse P, Togias A, Wheatley LM, Becker PM, Visness CM, Busse WW, Sette A, Jackson DJ. Correlates of cockroach nasal challenge responsiveness among sensitized urban children with asthma. J Allergy Clin Immunol Glob. 2026 Mar 18;5(3):100684. doi: 10.1016/j.jacig.2026.100684. eCollection 2026 May. | |
| 40714043 |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
Not provided
Participant level data access will be made available to the public at some point in the future via the mechanism of the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Not provided
The aim is to share data with the public within 24 months upon completion of the study.
ImmPort public data access.
Not provided
Recruited 308 participants with the goal of enrolling 80 participants into this trial. Each participant received a 12 month treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cockroach SCIT | Subcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. German cockroach allergenic extract: Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2021 | Feb 3, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo for German cockroach allergenic extract | Biological | Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
|
|
The Total Nasal Symptom Score (TNSS) Area under the curve (AUC) will be calculated separately at baseline and 12 months for each subject using the trapezoidal rule and divided by their baseline reactive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling AUC TNSS with factors for treatment arm, site, and baseline TNSS AUC. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome. |
| After 12 months |
| Change in 12-month Responsive Dose Between Cockroach SCIT and Placebo | The 12-month responsive dose is being calculated as the first dose that triggers a reaction of TNSS (Total Nasal Symptom Score) greater than or equal to 6 or a sneeze score of 3, whichever occurs first, in a sequence of up to 9 doses. To estimate the hazard ratio and 95% confidence interval, we are conducting an analysis using Cox regression with censoring, while controlling for the baseline responsive dose and site. Participants who do not experience a reaction before reaching the last dose will be considered right-censored. | After 12 months |
| Change in Log-transformed German Cockroach-specific IgE From Baseline to 12 Months Between Cockroach SCIT and Placebo | The difference in log-transformed German Cockroach-specific IgE between baseline and 12 months is being modeled using ANCOVA with factors for treatment arm, site, and the respective log-transformed IgE baseline as covariates. For each treatment group, we present least square means (LSmeans) and their associated standard errors (SEs). We report the difference in LSmeans between the treatment and placebo groups, along with the associated 95% confidence interval (CI) and p-value. | After 12 months |
| Change in Log-transformed German Cockroach-specific IgG4 From Baseline to 12 Months Between Cockroach SCIT and Placebo | The difference in log-transformed German Cockroach-specific IgG4 between baseline and 12 months is being modeled using ANCOVA with factors for treatment arm, site, and the respective log-transformed IgG4 baseline as covariates. For each treatment group, we present least square means (LSmeans) and their associated standard errors (SEs). We report the difference in LSmeans between the treatment and placebo groups, along with the associated 95% confidence interval (CI) and p-value. | After 12 months |
| Month 10, Month 12 |
| EXPLORATORY: Number of Days With Asthma Symptoms-by Treatment Group | Defined by the presence of wheezing or tightness in the chest, or cough. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Number of Nights With Asthma Symptoms-by Treatment Group | Defined by participant waking up during the night due to the presence of wheezing or tightness in the chest, or cough. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Number of Days With Albuterol Use-by Treatment Group | Albuterol is a bronchodilator used for asthma control. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Number of Nights With Albuterol use-by Treatment Group | Albuterol is a bronchodilator used for asthma control. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Asthma Treatment step-by Treatment Group | Defined by medication requirements for asthma control. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Number of Asthma exacerbations-by Treatment Group | Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the study. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Spirometry Measurement: Forced Expiratory Volume in 1 Second (FEV1)-by Treatment Group | FEV1 is air volume exhaled in 1 second during spirometry and is a measure of asthma severity. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Comparison of Rhinitis Symptom severity-by Treatment Group | Measured using the Modified Rhinitis Symptom Utility Index. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Comparison of Rhinitis Treatment step-by Treatment Group | Defined by medication requirements for rhinitis control. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Change in German Cockroach-Specific Serum IgG Over Time-by Treatment Group | Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Change in German Cockroach-Specific Component Allergens Over time-by Treatment Group | Including but not limited to the following component allergens: Bla g 1, Bla g 2, Bla g 4, Bla g 5 and Per a 7. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Change in Cockroach Skin Test Reactivity Over Time-by Treatment Group | As a measure of response to cockroach immunotherapy. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Change in Cockroach-Specific Blocking Antibodies Over Time-by Treatment Group | To explore serum measurement(s) of in-vitro cockroach antigen binding to B-cells. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Change in Cockroach-Specific T Cell Response-by Treatment Group | Limited to Part A only: Peripheral blood mononuclear cells (PBMCs) will be evaluated for the magnitude and phenotype of the Cockroach (CR)-specific T cell response to CR immunotherapy. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Change in Peripheral Blood Mononuclear Cells (PBMCs) Gene Expression Response to Cockroach (CR) Stimulation Over Time-by Treatment Group | To identify the changes in PBMC gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| EXPLORATORY: Change in Nasal Lavage Gene Expression Over Time-by Treatment Group | To identify the changes in nasal lavage gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group. | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Ann and Robert Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Henry Ford Health System: Division of Allergy and Immunology | Detroit | Michigan | 48202 | United States |
| St. Louis Children's Hospital: Allergy, Immunology and Pulmonary Medicine Program | St Louis | Missouri | 63110 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229-3039 | United States |
| University of Texas Southwestern Medical School | Dallas | Texas | 75390-8859 | United States |
| Derived |
| da Silva Antunes R, Sutherland A, Abawi A, Frazier A, Pomes A, Glesner J, Slater JE, Mindaye ST, Cho K, Zhou G, Ozanne MV, Calatroni A, Visness CM, Altman MC, Wood RA, O'Connor GT, Pongracic JA, Khurana Hershey GK, Kercsmar CM, Gruchalla RS, Gill M, Searing D, Liu AH, Zoratti E, Kattan M, Busse PJ, Sheehan W, Bacharier LB, Teach SJ, Wheatley LM, Togias A, Busse WW, Jackson DJ, Sette A. Cockroach immunotherapy modulates dominant T-cell responses independent of allergen extract content. J Allergy Clin Immunol. 2025 Nov;156(5):1303-1313. doi: 10.1016/j.jaci.2025.07.011. Epub 2025 Jul 24. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Inner-City Asthma Consortium | View source |
| FG001 | Placebo | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat population with available data
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cockroach SCIT | Subcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. German cockroach allergenic extract: Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467). |
| BG001 | Placebo | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Caretaker completed high school | Measure of Primary Caretaker completed high school | Count of Participants | Participants |
| |||||||||||||||
| Annual household income (<15k) | Category of annual household income that falls below $15,000 per year. | Count of participants with an annual household income that falls below $15,000 per year. | Count of Participants | Participants |
| ||||||||||||||
| Cockroach-specific IgE at Baseline | Cockroach-specific IgE Category at Baseline | Insufficient blood volume led to missing data for 2 participants. | Median | Inter-Quartile Range | kUA/L |
| |||||||||||||
| Cockroach-specific IgG4 at Baseline | Cockroach-specific IgG4 at screening | Insufficient blood volume led to missing data for 2 participants. | Median | Inter-Quartile Range | ng/mL |
| |||||||||||||
| NAC responsive dose at baseline | Subjects receive increasing doses of allergens, administered at defined time intervals (every 10-20 minutes) until they react to a dose. A reactive dose is determined when the Total Nasal Symptom Score exceeds 6 or if the subject sneezes 5 or more times. The Total Nasal Symptom Score (TNSS), with a possible score range of 0-12, is the sum of three participant-assessed symptom scores for rhinorrhea, nasal congestion, and nasal itching, as well as a staff-monitored sneezing count. Each symptom is rated on a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. | Count of Participants | 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 | Change in Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo | The study's primary endpoint is the mean TNSS change from baseline to 12 months, calculated as the difference between baseline and 12-month mean TNSS up to baseline responsive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling mean TNSS difference with factors for treatment arm, site, and baseline mean TNSS. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome. | All participants who are randomized, received at least one dose of study treatment, and receive at least one dose during the 12-month NAC. | Posted | Least Squares Mean | Standard Error | score on a scale | After 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Immunotherapy Related Adverse Events and Number of Immunotherapy Related Serious Adverse Events in the Course of Treatment. | Summary tables will present the total number of Immunotherapy related adverse event within the course of treatment. | All participants who sign consent and undergo study procedures at Screening. | Posted | Number | Adverse Events | After 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Area Under the Curve (AUC) Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo | The Total Nasal Symptom Score (TNSS) Area under the curve (AUC) will be calculated separately at baseline and 12 months for each subject using the trapezoidal rule and divided by their baseline reactive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling AUC TNSS with factors for treatment arm, site, and baseline TNSS AUC. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome. | All participants who are randomized, received at least one dose of study treatment, and receive at least one dose during the 12-month NAC. | Posted | Least Squares Mean | Standard Error | score on a scale | After 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 12-month Responsive Dose Between Cockroach SCIT and Placebo | The 12-month responsive dose is being calculated as the first dose that triggers a reaction of TNSS (Total Nasal Symptom Score) greater than or equal to 6 or a sneeze score of 3, whichever occurs first, in a sequence of up to 9 doses. To estimate the hazard ratio and 95% confidence interval, we are conducting an analysis using Cox regression with censoring, while controlling for the baseline responsive dose and site. Participants who do not experience a reaction before reaching the last dose will be considered right-censored. | All participants who are randomized, received at least one dose of study treatment, and receive at least one dose during the 12-month NAC. | Posted | Count of Participants | Participants | After 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Log-transformed German Cockroach-specific IgE From Baseline to 12 Months Between Cockroach SCIT and Placebo | The difference in log-transformed German Cockroach-specific IgE between baseline and 12 months is being modeled using ANCOVA with factors for treatment arm, site, and the respective log-transformed IgE baseline as covariates. For each treatment group, we present least square means (LSmeans) and their associated standard errors (SEs). We report the difference in LSmeans between the treatment and placebo groups, along with the associated 95% confidence interval (CI) and p-value. | All participants who are randomized, received at least one dose of study treatment, and receive at least one dose during the 12-month NAC. | Posted | Least Squares Mean | Standard Error | Log(kuA/L) | After 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Log-transformed German Cockroach-specific IgG4 From Baseline to 12 Months Between Cockroach SCIT and Placebo | The difference in log-transformed German Cockroach-specific IgG4 between baseline and 12 months is being modeled using ANCOVA with factors for treatment arm, site, and the respective log-transformed IgG4 baseline as covariates. For each treatment group, we present least square means (LSmeans) and their associated standard errors (SEs). We report the difference in LSmeans between the treatment and placebo groups, along with the associated 95% confidence interval (CI) and p-value. | All participants who are randomized, received at least one dose of study treatment, and receive at least one dose during the 12-month NAC. | Posted | Least Squares Mean | Standard Error | Log(ng/mL) | After 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Composite Asthma Severity Score (CASI)-by Treatment Group | The Composite Asthma Severity Index (CASI) is a comprehensive severity scale combining multiple facets of asthma severity: impairment, risk, and treatment. The CASI score ranges from 0 to 20 points, with higher scores indicating higher levels of severity, and includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. | Not Posted | Month 10, Month 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Number of Days With Asthma Symptoms-by Treatment Group | Defined by the presence of wheezing or tightness in the chest, or cough. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Number of Nights With Asthma Symptoms-by Treatment Group | Defined by participant waking up during the night due to the presence of wheezing or tightness in the chest, or cough. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Number of Days With Albuterol Use-by Treatment Group | Albuterol is a bronchodilator used for asthma control. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Number of Nights With Albuterol use-by Treatment Group | Albuterol is a bronchodilator used for asthma control. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Asthma Treatment step-by Treatment Group | Defined by medication requirements for asthma control. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Number of Asthma exacerbations-by Treatment Group | Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the study. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Spirometry Measurement: Forced Expiratory Volume in 1 Second (FEV1)-by Treatment Group | FEV1 is air volume exhaled in 1 second during spirometry and is a measure of asthma severity. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Comparison of Rhinitis Symptom severity-by Treatment Group | Measured using the Modified Rhinitis Symptom Utility Index. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Comparison of Rhinitis Treatment step-by Treatment Group | Defined by medication requirements for rhinitis control. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Change in German Cockroach-Specific Serum IgG Over Time-by Treatment Group | Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Change in German Cockroach-Specific Component Allergens Over time-by Treatment Group | Including but not limited to the following component allergens: Bla g 1, Bla g 2, Bla g 4, Bla g 5 and Per a 7. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Change in Cockroach Skin Test Reactivity Over Time-by Treatment Group | As a measure of response to cockroach immunotherapy. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Change in Cockroach-Specific Blocking Antibodies Over Time-by Treatment Group | To explore serum measurement(s) of in-vitro cockroach antigen binding to B-cells. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Change in Cockroach-Specific T Cell Response-by Treatment Group | Limited to Part A only: Peripheral blood mononuclear cells (PBMCs) will be evaluated for the magnitude and phenotype of the Cockroach (CR)-specific T cell response to CR immunotherapy. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Change in Peripheral Blood Mononuclear Cells (PBMCs) Gene Expression Response to Cockroach (CR) Stimulation Over Time-by Treatment Group | To identify the changes in PBMC gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EXPLORATORY: Change in Nasal Lavage Gene Expression Over Time-by Treatment Group | To identify the changes in nasal lavage gene expression response to cockroach stimulation over time and compare those changes between the treated (German cockroach allergenic extract ) and untreated (placebo) group. | Not Posted | Baseline (Pre-treatment) through Study Completion, an Average of 1 Year | Participants |
Adverse events (including SAEs) were collected from the time of obtaining informed consent until 30 days after a participant completed study participation or until 30 days after the participant prematurely withdrew or was withdrawn from the study.
The same as clinicaltrials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cockroach SCIT | Subcutaneous immunotherapy (SCIT): German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. German cockroach allergenic extract: Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467). | 0 | 40 | 2 | 40 | 34 | 40 |
| EG001 | Placebo | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). | 0 | 42 | 0 | 42 | 35 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Peak expiratory flow rate decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2022 | Feb 3, 2023 | SAP_001.pdf |
Not provided
|
| ≥ 12 years |
|
|
|
|
|
|
|
|
|
|
Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
|
|
| OG001 | Placebo | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
|
|
|
| OG001 | Placebo | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
|
|
|
| OG001 | Placebo | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
|
|
|
| OG001 | Placebo | Subcutaneous immunotherapy (SCIT): Placebo for German cockroach allergenic extract. 40 participants 8 to 17 years of age will be randomized to this treatment arm. -In the first stage of dose escalation, up to 2 doses of the assigned SCIT treatment will be given weekly, separated by a minimum of 2 days. During the second phase of dose escalation, up to 1 dose of the assigned SCIT treatment will be given weekly, separated by a minimum of 5 days. After maintenance dose is achieved, participants will receive two additional maintenance level-doses spaced approximately 2 weeks apart, followed by maintenance injections every 4 weeks for the remainder of the treatment period. The treatment is for a period of 12 months. Placebo for German cockroach allergenic extract: Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%). |
|
|
|