AsthmaPhase 1/2SCITMONCT02532179

Subcutaneous Immunotherapy for Mouse in Adults

A Phase 1/2 study testing Mouse Allergenic Extract in people with Asthma and Perennial Allergic Rhinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma, Perennial Allergic Rhinitis
What is being tested?: Mouse Allergenic Extract
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 4 sitesUnited States
Study dates: Oct 2015to Oct 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

Show all 14Show fewer

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Johns Hopkins Children's Center: Department of Allergy & Immunology
Baltimore, Maryland, 21287
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Henry Ford Health System: Division of Allergy and Immunology
Detroit, Michigan, 48202
Children's National Health System
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)

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.

Read the 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).

Conditions: Asthma, Perennial Allergic Rhinitis
Being tested: Mouse Allergenic Extract
Keywords: subcutaneous immunotherapy (SCIT), glycerinated mouse allergenic extract, mouse specific IgE, mouse specific IgG and IgG4, mouse prick skin test wheal
Medical subject headings: Asthma, Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mouse Allergenic ExtractBiological
Also called mouse epithelial extract, allergenic extract of Mus musculus
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.

Study groups in NCT02532179
Study group	Role	What they receive
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. Receives: Biological: Mouse Allergenic Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Reported Adverse Events (AEs)
Frequency of any AEs tabulated by preferred event term.
Measured: 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.
Measured: Baseline (Pre-Treatment) through 24 Weeks of Treatment

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Pre-Treatment) to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Oct 2016

First posted25 Aug 2015 (estimated)
Study startOct 2015
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02532179
Sponsor's protocol ID: DAIT ICAC-26
Acronym: SCITMO
Status last verified: Feb 2018
First submitted: 21 Aug 2015
Last updated: 7 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)
ClinicalTrials.gov ID: NCT02532179
Acronym / sponsor ID: SCITMO / DAIT ICAC-26
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
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Inner-City Asthma Consortium
Study start: Oct 2015
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 25 Aug 2015 (estimated)
Results: Posted 28 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mouse Allergenic Extract	Experimental	Biological: Mouse Allergenic ExtractParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (14 listed)

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);

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mouse Allergenic ExtractAlso: mouse epithelial extract, allergenic extract of Mus musculusSubjects 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.	Biological	Mouse Allergenic Extract

Primary outcome

Number of Reported Adverse Events (AEs)
Time frame: Baseline (Pre-Treatment) through 24 Weeks of Treatment
Frequency of any AEs tabulated by preferred event term.
Number of Reported Serious Adverse Events (SAEs)
Time frame: Baseline (Pre-Treatment) through 24 Weeks of Treatment
Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation.

4 secondary outcomes

Change in Mouse-Specific IgE Antibodies
Time frame: Baseline (Pre-Treatment) through Week 24
Change in Mouse-Specific IgG Antibodies
Time frame: Baseline (Pre-Treatment) to Week 24
Change in Mouse-Specific IgG4 Antibodies
Time frame: Baseline (Pre-Treatment) to Week 24
Change in In-vitro Mouse Antigen Binding to B-cells
Time frame: Baseline (Pre-Treatment) to Week 24

Results and safety

Results posted to the registry on 28 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mouse Allergenic Extract	12	9

Primary outcome: Number of Reported Adverse Events (AEs)

Time frame: Baseline (Pre-Treatment) through 24 Weeks of Treatment. Number. Unit: Events

Measure	Mouse Allergenic Extract n = 12
Total adverse events	9
Abdominal pain	1
Vomiting	1
Injection site swelling	2
Peak expiratory flow rate decreased	2
Pruritus generalized	1
Skin lesion	1
Flushing	1

Population analysed: Intent-to-treat

Primary outcome: Number of Reported Serious Adverse Events (SAEs)

Time frame: Baseline (Pre-Treatment) through 24 Weeks of Treatment. Number. Unit: Number of SAEs

Measure	Mouse Allergenic Extract n = 12
Value	0

Population analysed: Intent-to-treat

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment through end of study (up to 24 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mouse Allergenic Extract	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
History, project and sites of the Inner-city Asthma Consortium (ICAC)Link provided by the sponsor.
Information: National Asthma Education and Prevention Program (NAEPP)Link provided by the sponsor.

Related trials for Asthma

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Wood, M.D. study chair

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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Reported Adverse Events (AEs) (time frame: Baseline (Pre-Treatment) through 24 Weeks of Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02532179.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.