Trial Outcomes & Findings for FARE Peanut SLIT and Early Tolerance Induction (NCT NCT02304991)
NCT ID: NCT02304991
Last Updated: 2022-01-10
Results Overview
The primary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during DBPCFC after 36 months of peanut SLIT (desensitization). DBPCFC Challenge Score scale: Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
36 months
Results posted on
2022-01-10
Participant Flow
Participant milestones
| Measure |
Peanut (Liquid Peanut Extract) SLIT
After the Double-Blind, Placebo-Controlled Food Challenge (DBPCFC), subjects randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
After the Double-Blind, Placebo-Controlled Food Challenge (DBPCFC), subjects randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FARE Peanut SLIT and Early Tolerance Induction
Baseline characteristics by cohort
| Measure |
Placebo Glycerin SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
Total
n=50 Participants
Total of all reporting groups
|
Peanut (Liquid Peanut Extract) SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
2.4 years
n=7 Participants
|
2.2 years
n=5 Participants
|
2.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
25 Participants
n=5 Participants
|
|
Peanut-Specific IgE
|
37.8 kUA/L
n=7 Participants
|
32.2 kUA/L
n=5 Participants
|
28.1 kUA/L
n=5 Participants
|
|
Peanut Skin Prick Test Wheal Size
|
11.2 mm
n=7 Participants
|
11.1 mm
n=5 Participants
|
11.0 mm
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero
The primary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during DBPCFC after 36 months of peanut SLIT (desensitization). DBPCFC Challenge Score scale: Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7.
Outcome measures
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Desensitization After 36 Months of Peanut SLIT or Placebo SLIT
|
4.9 score on a scale
Interval 3.7 to 6.2
|
2.5 score on a scale
Interval 1.6 to 3.3
|
SECONDARY outcome
Timeframe: 39 monthsPopulation: Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero
A secondary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). DBPCFC Challenge Score scale: Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7.
Outcome measures
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Tolerance 3 Months After Discontinuing Peanut SLIT or Placebo SLIT
|
4.0 score on a scale
Interval 2.6 to 5.4
|
1.0 score on a scale
Interval 0.0 to 1.9
|
SECONDARY outcome
Timeframe: 0 months to 36 monthsPopulation: Per protocol analysis of patients with available samples.
The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization. Peanut-specific IgE measured at baseline and at completion of peanut SLIT (36 months). Change in IgE reported in kUA/L.
Outcome measures
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=17 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=12 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgE)
|
-19.4 kUA/L of peanut-specific IgE
Interval -39.6 to 0.8
|
65.2 kUA/L of peanut-specific IgE
Interval -6.2 to 136.5
|
SECONDARY outcome
Timeframe: 0 months to 36 monthsPopulation: Per protocol analysis of patients with available samples.
The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization. Peanut-specific IgG4 measured at baseline and at completion of peanut SLIT (36 months). Change in IgG4 reported in mg/L.
Outcome measures
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=17 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=11 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgG4)
|
3.9 mg/L of peanut-specific IgG4
Interval 1.7 to 6.1
|
-0.2 mg/L of peanut-specific IgG4
Interval -1.8 to 1.5
|
SECONDARY outcome
Timeframe: 0 months to 36 monthsPopulation: Per protocol analysis of patients with available samples.
The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization. Peanut-skin prick test measured at baseline and at completion of peanut SLIT (36 months). Change in skin prick test reported in mm wheal diameter.
Outcome measures
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=20 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=18 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut Skin Prick Test)
|
-7.7 mm
Interval -9.8 to -5.6
|
1.8 mm
Interval -1.4 to 4.9
|
SECONDARY outcome
Timeframe: 39 monthsIncidence of all serious adverse events from initial enrollment through the end of the 3 month avoidance period reported as the number of participants experiencing a serious adverse event.
Outcome measures
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=25 Participants
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events With Peanut SLIT Versus Placebo SLIT
|
0 Participants
|
1 Participants
|
Adverse Events
Peanut (Liquid Peanut Extract) SLIT
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo Glycerin SLIT
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=25 participants at risk
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=25 participants at risk
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Immune system disorders
Acute Lymphoblastic Leukemia
|
0.00%
0/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
Other adverse events
| Measure |
Peanut (Liquid Peanut Extract) SLIT
n=25 participants at risk
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Liquid Peanut Extract: 5000mcg/ml peanut protein
|
Placebo Glycerin SLIT
n=25 participants at risk
After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.
Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin
|
80.0%
20/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
68.0%
17/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
|
Gastrointestinal disorders
Gastrointestinal
|
44.0%
11/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
32.0%
8/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory
|
24.0%
6/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
24.0%
6/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory
|
24.0%
6/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
16.0%
4/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
|
Skin and subcutaneous tissue disorders
Oropharyngeal itch
|
80.0%
20/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
32.0%
8/25 • Adverse event data was collected beginning with completion of the qualifying DBPCFC and enrollment in the study through the completion of the tolerance DBPCFC at the 39 month study time point.
|
Additional Information
Edwin Kim, MD, MS
University of North Carolina School of Medicine
Phone: 919-962-4960
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place