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FARE Peanut SLIT and Early Tolerance Induction (FARE/SLIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02304991
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : December 16, 2021
Last Update Posted : January 10, 2022
Sponsor:
Collaborators:
Food Allergy Research & Education
National Center for Complementary and Integrative Health (NCCIH)
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Peanut Hypersensitivity
Food Allergy
Food Hypersensitivity
Peanut Allergy
Interventions Drug: Liquid Peanut Extract
Drug: Placebo Glycerin SLIT
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description

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

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
Period Title: Overall Study
Started 25 25
Completed 18 15
Not Completed 7 10
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
25
 100.0%
25
 100.0%
50
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
2.2
(1.1 to 3.9)
2.4
(1.0 to 4.0)
2.2
(1.0 to 4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
13
  52.0%
9
  36.0%
22
  44.0%
Male
12
  48.0%
16
  64.0%
28
  56.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
25
 100.0%
25
 100.0%
50
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
1
   4.0%
0
   0.0%
1
   2.0%
Asian
1
   4.0%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   8.0%
2
   4.0%
White
21
  84.0%
23
  92.0%
44
  88.0%
More than one race
2
   8.0%
0
   0.0%
2
   4.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25
 100.0%
25
 100.0%
50
 100.0%
Peanut-Specific IgE  
Mean (Full Range)
Unit of measure:  kUA/L
Number Analyzed 25 participants 25 participants 50 participants
28.1
(0.3 to 180.0)
37.8
(0.8 to 113.0)
32.2
(0.3 to 180.0)
Peanut Skin Prick Test Wheal Size  
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 25 participants 25 participants 50 participants
11.0
(4.0 to 20.5)
11.2
(5.5 to 24.5)
11.1
(4.0 to 24.5)
1.Primary Outcome
Title Desensitization After 36 Months of Peanut SLIT or Placebo SLIT
Hide Description

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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description:

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

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
Overall Number of Participants Analyzed 25 25
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
4.9
(3.7 to 6.2)
2.5
(1.6 to 3.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut (Liquid Peanut Extract) SLIT, Placebo Glycerin SLIT
Comments Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Tolerance 3 Months After Discontinuing Peanut SLIT or Placebo SLIT
Hide Description

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.
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description:

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

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
Overall Number of Participants Analyzed 25 25
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
4.0
(2.6 to 5.4)
1.0
(0.0 to 1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut (Liquid Peanut Extract) SLIT, Placebo Glycerin SLIT
Comments Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgE)
Hide Description

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.
Time Frame 0 months to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis of patients with available samples.
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description:

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

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
Overall Number of Participants Analyzed 17 12
Mean (95% Confidence Interval)
Unit of Measure: kUA/L of peanut-specific IgE
-19.4
(-39.6 to 0.8)
65.2
(-6.2 to 136.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut (Liquid Peanut Extract) SLIT, Placebo Glycerin SLIT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgG4)
Hide Description

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.
Time Frame 0 months to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis of patients with available samples.
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description:

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

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
Overall Number of Participants Analyzed 17 11
Mean (95% Confidence Interval)
Unit of Measure: mg/L of peanut-specific IgG4
3.9
(1.7 to 6.1)
-0.2
(-1.8 to 1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut (Liquid Peanut Extract) SLIT, Placebo Glycerin SLIT
Comments Per protocol analysis of patients with available samples.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut Skin Prick Test)
Hide Description

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.
Time Frame 0 months to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis of patients with available samples.
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description:

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

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
Overall Number of Participants Analyzed 20 18
Mean (95% Confidence Interval)
Unit of Measure: mm
-7.7
(-9.8 to -5.6)
1.8
(-1.4 to 4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut (Liquid Peanut Extract) SLIT, Placebo Glycerin SLIT
Comments Per protocol analysis of patients with available samples.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Experiencing Serious Adverse Events With Peanut SLIT Versus Placebo SLIT
Hide Description Incidence 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.
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description:

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

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
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   4.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut (Liquid Peanut Extract) SLIT, Placebo Glycerin SLIT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Hide Arm/Group Description

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

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
All-Cause Mortality
Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      1/25 (4.00%)    
Immune system disorders     
Acute Lymphoblastic Leukemia *  0/25 (0.00%)  0 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Peanut (Liquid Peanut Extract) SLIT Placebo Glycerin SLIT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/25 (96.00%)      21/25 (84.00%)    
Gastrointestinal disorders     
Gastrointestinal *  11/25 (44.00%)  8/25 (32.00%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory *  6/25 (24.00%)  6/25 (24.00%) 
Lower respiratory *  6/25 (24.00%)  4/25 (16.00%) 
Skin and subcutaneous tissue disorders     
Skin *  20/25 (80.00%)  17/25 (68.00%) 
Oropharyngeal itch *  20/25 (80.00%)  8/25 (32.00%) 
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edwin Kim, MD, MS
Organization: University of North Carolina School of Medicine
Phone: 919-962-4960
EMail: edwinkim@email.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02304991    
Other Study ID Numbers: 14-0648
R01AT004435-07 ( U.S. NIH Grant/Contract )
First Submitted: November 21, 2014
First Posted: December 2, 2014
Results First Submitted: November 17, 2021
Results First Posted: December 16, 2021
Last Update Posted: January 10, 2022