Trial Outcomes & Findings for Subcutaneous Immunotherapy for Mouse in Adults (NCT NCT02532179)
NCT ID: NCT02532179
Last Updated: 2018-03-07
Results Overview
Frequency of any AEs tabulated by preferred event term.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline (Pre-Treatment) through 24 Weeks of Treatment
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
|
9
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Pregnancy
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1
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Overall Study
Subject received depot steroid injection
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1
|
Baseline Characteristics
Subcutaneous Immunotherapy for Mouse in Adults
Baseline characteristics by cohort
| Measure |
Mouse Allergenic Extract
n=12 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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12 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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27.3 years
STANDARD_DEVIATION 7.54 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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9 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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2 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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12 participants
n=5 Participants
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Mouse-Specific Serum Immunoglobulin E (IgE) Levels
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2.34 kU/L
STANDARD_DEVIATION 0.45 • n=5 Participants
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Mouse-Specific Serum Immunoglobulin G (IgG) Levels
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1.23 kU/L
STANDARD_DEVIATION 0.20 • n=5 Participants
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Mouse-Specific Serum Immunoglobulin G4 (IgG4) Levels
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0.08 kU/L
STANDARD_DEVIATION 0.35 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Pre-Treatment) through 24 Weeks of TreatmentPopulation: Intent-to-treat
Frequency of any AEs tabulated by preferred event term.
Outcome measures
| Measure |
Mouse Allergenic Extract
n=12 Participants
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.
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|---|---|
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Number of Reported Adverse Events (AEs)
Total adverse events
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9 Events
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Number of Reported Adverse Events (AEs)
Abdominal pain
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1 Events
|
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Number of Reported Adverse Events (AEs)
Vomiting
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1 Events
|
|
Number of Reported Adverse Events (AEs)
Injection site swelling
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2 Events
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Number of Reported Adverse Events (AEs)
Peak expiratory flow rate decreased
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2 Events
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Number of Reported Adverse Events (AEs)
Pruritus generalized
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1 Events
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Number of Reported Adverse Events (AEs)
Skin lesion
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1 Events
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Number of Reported Adverse Events (AEs)
Flushing
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1 Events
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PRIMARY outcome
Timeframe: Baseline (Pre-Treatment) through 24 Weeks of TreatmentPopulation: Intent-to-treat
Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation.
Outcome measures
| Measure |
Mouse Allergenic Extract
n=12 Participants
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.
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|---|---|
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Number of Reported Serious Adverse Events (SAEs)
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0 Number of SAEs
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SECONDARY outcome
Timeframe: Baseline (Pre-Treatment) through Week 24Population: Intent-to-treat
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.
Outcome measures
| Measure |
Mouse Allergenic Extract
n=12 Participants
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.
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|---|---|
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Change in Mouse-Specific IgE Antibodies
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3 Ratio
Interval 2.09 to 4.29
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SECONDARY outcome
Timeframe: Baseline (Pre-Treatment) to Week 24Population: Intent-to-treat
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.
Outcome measures
| Measure |
Mouse Allergenic Extract
n=12 Participants
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.
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|---|---|
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Change in Mouse-Specific IgG Antibodies
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3.82 Ratio
Interval 2.77 to 5.25
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SECONDARY outcome
Timeframe: Baseline (Pre-Treatment) to Week 24Population: Intent-to-treat
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.
Outcome measures
| Measure |
Mouse Allergenic Extract
n=12 Participants
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.
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|---|---|
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Change in Mouse-Specific IgG4 Antibodies
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6.55 Ratio
Interval 3.87 to 11.06
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SECONDARY outcome
Timeframe: Baseline (Pre-Treatment) to Week 24Population: No analysis conducted: Sponsor's decision to not pursue assay development in this study.
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.
Outcome measures
Outcome data not reported
Adverse Events
Mouse Allergenic Extract
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mouse Allergenic Extract
n=12 participants at risk
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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|---|---|
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General disorders
Injection site swelling
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16.7%
2/12 • Number of events 2 • Enrollment through end of study (up to 24 weeks)
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Gastrointestinal disorders
Abdominal Pain
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8.3%
1/12 • Number of events 1 • Enrollment through end of study (up to 24 weeks)
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Gastrointestinal disorders
Vomiting
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8.3%
1/12 • Number of events 1 • Enrollment through end of study (up to 24 weeks)
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Skin and subcutaneous tissue disorders
Pruritus generalised
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8.3%
1/12 • Number of events 1 • Enrollment through end of study (up to 24 weeks)
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Investigations
Peak expiratory flow rate decreased
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16.7%
2/12 • Number of events 2 • Enrollment through end of study (up to 24 weeks)
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Skin and subcutaneous tissue disorders
Skin lesion
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8.3%
1/12 • Number of events 1 • Enrollment through end of study (up to 24 weeks)
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Vascular disorders
Flushing
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8.3%
1/12 • Number of events 1 • Enrollment through end of study (up to 24 weeks)
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Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place