Cockroach Immunotherapy in Children and Adolescents

NCT03541187 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: DAIT ICAC-28UM1AI114271NIAID CRMS ID#: 38517
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Persistent Asthma

Keywords

cockroach; immunotherapy; inner city asthma; subcutaneous immunotherapy (SCIT); Nasal Allergen Challenge (NAC)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of Immunotherapy Related Adverse Events and Number of Immunotherapy Related Serious Adverse Events in 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

  After 12 months

• Change in 12-month Responsive Dose Between Cockroach SCIT and Placebo

  After 12 months

• Change in Log-transformed German Cockroach-specific IgE From Baseline to 12 Months Between Cockroach SCIT and Placebo

  After 12 months

• Change in Log-transformed German Cockroach-specific IgG4 From Baseline to 12 Months Between Cockroach SCIT and Placebo

  After 12 months

Other Outcomes (17)

• EXPLORATORY: Composite Asthma Severity Score (CASI)-by Treatment Group

  Month 10, Month 12

• EXPLORATORY: Number of Days With Asthma Symptoms-by Treatment Group

  Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

• EXPLORATORY: Number of Nights With Asthma Symptoms-by Treatment Group

  Baseline (Pre-treatment) through Study Completion, an Average of 1 Year

Study Arms (2)

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.

Biological: German cockroach allergenic extract

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.

Biological: Placebo for German cockroach allergenic extract

Interventions

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).

Also known as: Blattella germanica allergenic extract

G. cockroach allergenic extract

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%).

Also known as: Placebo for Blattella germanica allergenic extract

Placebo

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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):
• Have a history of persistent asthma, for a minimum of 1 year before study entry:
• A diagnosis of asthma will be defined as a report by the caretaker that the subject had a clinical diagnosis of asthma made by a clinician ≥1 year ago, resulting in a prescription of preventative asthma medication, and
• Must have persistent asthma as defined by the current need for at least 88 mcg fluticasone (or the equivalent of another inhaled corticosteroid) to control asthma at the time of screening.
• At the time of randomization, the subject's asthma must be well controlled as defined by:
• A Forced Expiratory Volume in 1 second (FEV1) ≥80% predicted, and
• An Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) score ≥20.
• Is sensitive to German cockroach as documented by:
• a positive (≥3 mm greater than negative control) skin prick test result, and
• detectable German cockroach specific Immunoglobulin E (IgE) (≥ 0.35 kUA/L).
• 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.

You may not qualify if:

• 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:
• Requires a dose \>500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid,
• Has received more than 2 courses of oral or parenteral corticosteroids in the last 12 months or one course within the last 3 months prior to study entry,
• Has been treated with depot steroids within the 3 months prior to study entry,
• Has been hospitalized for asthma within the 6 months prior to study entry, or
• Has had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to study entry.
• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Inner-City Asthma Consortium: collaborator
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (11)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center - IMPACT DC

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 University

Baltimore, Maryland, 21205, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System: Division of Allergy and Immunology

Detroit, Michigan, 48202, United States

Location

St. Louis Children's Hospital: Allergy, Immunology and Pulmonary Medicine Program

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229-3039, United States

Location

University of Texas Southwestern Medical School

Dallas, Texas, 75390-8859, United States

Location

Related Publications (1)

• 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.

  PMID: 40714043 DERIVED

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• Inner-City Asthma Consortium

Results Point of Contact

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

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• 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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 30, 2018
• Study Start: July 16, 2018
• Primary Completion: June 2, 2022
• Study Completion: June 3, 2022
• Last Updated: May 22, 2023
• Results First Posted: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The aim is to share data with the public within 24 months upon completion of the study.
• Access Criteria: ImmPort public data access.

Locations

US (11)