Trial Outcomes & Findings for Desensitization and Cross-Desensitization During Oral Grass or Ragweed Pollen Immunotherapy (NCT NCT02676765)
NCT ID: NCT02676765
Last Updated: 2022-03-18
Results Overview
Change in the dose of allergen eliciting a wheal 3 mm greater than negative control upon skin prick testing (PC3)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
Assessed at 2 weeks and at the end of the study (2 months)
Results posted on
2022-03-18
Participant Flow
After enrollment, allergen skin prick testing was performed to confirm sensitization to the required allergens. Of the 58 subjects enrolled, 37 were determined to lack sensitization to timothy grass pollen or ragweed pollen, plus at least one other environmental allergen. These subjects were excluded from the study prior to randomization. One subjected qualified, but was lost to follow up prior to randomizing.
Participant milestones
| Measure |
Sublingual Allergen Tablets
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sublingual Allergen Tablets
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sublingual Allergen Tablets
n=10 Participants
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
n=10 Participants
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Assessed at 2 weeks and at the end of the study (2 months)Population: One subject from placebo arm not analyzed due to missing data
Change in the dose of allergen eliciting a wheal 3 mm greater than negative control upon skin prick testing (PC3)
Outcome measures
| Measure |
Sublingual Allergen Tablets
n=10 Participants
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
n=8 Participants
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
|---|---|---|
|
Change in PC3
|
-0.2750 Change in log dilution of allergen
Interval -1.59 to -0.02
|
-0.0250 Change in log dilution of allergen
Interval -0.5275 to 0.25
|
PRIMARY outcome
Timeframe: Assessed at 2 weeks and at the end of the study (2 months)Change in the dose of allergen eliciting a 50% increase in number of basophils positive for CD63 and/or CD203c relative to negative and positive controls
Outcome measures
| Measure |
Sublingual Allergen Tablets
n=10 Participants
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
n=9 Participants
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
|---|---|---|
|
Change in Basophil Activation
|
-4.1100 Change in log dilution of allergen
Interval -7.805 to -0.705
|
0.1300 Change in log dilution of allergen
Interval -1.9275 to 2.96
|
SECONDARY outcome
Timeframe: Assessed at 2 weeks and at the end of the study (2 months)Change in the dose of an unrelated allergen eliciting a wheal 3 mm greater than negative control upon skin prick testing (PC3)
Outcome measures
| Measure |
Sublingual Allergen Tablets
n=10 Participants
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
n=9 Participants
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
|---|---|---|
|
Cross-desensitization - PC3
|
-0.0350 Change in log dilution of allergen
Interval -1.025 to 0.36
|
0.8000 Change in log dilution of allergen
Interval -0.195 to 1.5175
|
SECONDARY outcome
Timeframe: Assessed at 2 weeks and at the end of the study (2 months)Change in the dose of allergen eliciting a 50% increase in number of basophils positive for CD63 and/or CD203c relative to negative and positive controls
Outcome measures
| Measure |
Sublingual Allergen Tablets
n=10 Participants
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
n=9 Participants
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
|---|---|---|
|
Cross-desensitization - Basophil Activation
|
-0.2000 Change in log dilution of allergen
Interval -2.3825 to 0.3075
|
-0.1500 Change in log dilution of allergen
Interval -5.6625 to 0.705
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at enrollment, at 2 weeks, and at the end of the study (2 months)The percent of total serum IgE that is specific for the primary allergen will be compared to the degree (if any) of cross-desensitization seen by skin prick or basophil activation testing
Outcome measures
Outcome data not reported
Adverse Events
Sublingual Allergen Tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sublingual Allergen Tablets
n=10 participants at risk
Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.
allergen extract tablet: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
Placebo
n=9 participants at risk
Subjects will be administered placebo sublingual tablets
Placebo tablet: 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation and ear fullness
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected for a total of 2 months while subjects were on treatment/placebo.
|
0.00%
0/9 • Adverse event data was collected for a total of 2 months while subjects were on treatment/placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place