Trial Outcomes & Findings for Walnut Oral Immunotherapy for Tree Nut Allergy (NCT NCT01546753)
NCT ID: NCT01546753
Last Updated: 2023-05-12
Results Overview
Determine in tree nut allergic subjects the effectiveness of walnut oral immunotherapy on clinical desensitization to a second tree nut ("test tree nut") causing allergy when compared to placebo treatment, as measured by the change in cumulative dose from baseline oral food challenge (OFC) to the OFC to the test tree nut at approximately 38 weeks on therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
38 weeks of therapy
Results posted on
2023-05-12
Participant Flow
Participants were recruited from allergy clinics, research databases and advertisement. Study recruitment occurred from April 2012 through September 2014.
Following consent and enrollment, screening included allergen skin testing, allergen-IgE testing, immune studies and DBPCFCs to placebo, walnut and at least one tree nut. Those meeting inclusion criteria were randomized 2:1 to blinded OIT (walnut vs. placebo) through week 38 when DBPCFCs were conducted. Unblinding of treatment assignment occurred at week 38; placebo subjects crossed over to active (walnut) OIT. OIT after week 38 was given daily as open-label treatment.
Participant milestones
| Measure |
Walnut Protein Powder
Up to 298 weeks for active treatment subjects
Walnut Protein Powder: Subjects randomized to the active treatment group begins with blinded study product (walnut) dosing utilizing a one-day oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Unblinding to treatment group occurs at week 38, and active (walnut OIT) treatment subjects will continue on open-label walnut OIT maintenance dosing daily for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
Oat Powder (placebo): Subjects randomized to the placebo (oat flour) group will undergo the same one-day desensitization protocol as the active (walnut) treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Unblinding to treatment group occurs at week 38, and placebo subjects will be crossed over to active treatment with open-label walnut OIT with the same protocol as outlined for the active treatment group for up to 298 weeks of treatment beginning with initial escalation day.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
4
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Walnut Protein Powder
Up to 298 weeks for active treatment subjects
Walnut Protein Powder: Subjects randomized to the active treatment group begins with blinded study product (walnut) dosing utilizing a one-day oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Unblinding to treatment group occurs at week 38, and active (walnut OIT) treatment subjects will continue on open-label walnut OIT maintenance dosing daily for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
Oat Powder (placebo): Subjects randomized to the placebo (oat flour) group will undergo the same one-day desensitization protocol as the active (walnut) treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Unblinding to treatment group occurs at week 38, and placebo subjects will be crossed over to active treatment with open-label walnut OIT with the same protocol as outlined for the active treatment group for up to 298 weeks of treatment beginning with initial escalation day.
|
|---|---|---|
|
Overall Study
anxiety
|
1
|
1
|
|
Overall Study
diagnosis of ulcerative colitis
|
1
|
0
|
Baseline Characteristics
Walnut Oral Immunotherapy for Tree Nut Allergy
Baseline characteristics by cohort
| Measure |
Walnut Protein Powder
n=10 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
n=4 Participants
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.7 years
n=5 Participants
|
9.2 years
n=7 Participants
|
9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
subjects with asthma
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
subjects with atopic dermatitis
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
subjects with allergic rhinitis
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 38 weeks of therapyPopulation: Participants completing the 38 week food challenge assessment were included in the analysis of primary outcome which was change in the cumulative tolerated dose during food challenge from baseline to week 38.
Determine in tree nut allergic subjects the effectiveness of walnut oral immunotherapy on clinical desensitization to a second tree nut ("test tree nut") causing allergy when compared to placebo treatment, as measured by the change in cumulative dose from baseline oral food challenge (OFC) to the OFC to the test tree nut at approximately 38 weeks on therapy.
Outcome measures
| Measure |
Walnut Protein Powder
n=8 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
n=4 Participants
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Open-label Walnut Protein Powder
This is the open-label phase of active dosing following the blinded treatment protocol through week 38. Following treatment unblinding at week 38, subjects on active treatment continued on daily maintenance treatment and those on placebo crossed over to active therapy per study protocol. All subjects in the open-label dosing phase were continued until the end of study at week 298 unless early exit criteria satisfied or the subject discontinued from the study.
|
|---|---|---|---|
|
Effectiveness of Walnut OIT on Clinical Desensitization to Test Tree Nut as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 at Oral Food Challenge
|
2.6 grams
Interval 1.55 to 3.54
|
0.05 grams
Interval -0.47 to 0.17
|
—
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: Participants completing the 38 week food challenge assessment were included in the analysis of primary outcome which was change in the cumulative tolerated dose during food challenge from baseline to week 38.
Determine in tree nut allergic subjects the effectiveness of walnut oral immunotherapy on clinical desensitization to walnut causing allergy when compared to placebo treatment, as measured by the change in cumulative dose from baseline oral food challenge (OFC) to the OFC to the walnut at approximately 38 weeks on therapy.
Outcome measures
| Measure |
Walnut Protein Powder
n=8 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
n=4 Participants
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Open-label Walnut Protein Powder
This is the open-label phase of active dosing following the blinded treatment protocol through week 38. Following treatment unblinding at week 38, subjects on active treatment continued on daily maintenance treatment and those on placebo crossed over to active therapy per study protocol. All subjects in the open-label dosing phase were continued until the end of study at week 298 unless early exit criteria satisfied or the subject discontinued from the study.
|
|---|---|---|---|
|
Evaluation of Desensitization to Walnut Protein as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 Oral Food Challenge
|
4.4 grams
Interval 3.1 to 4.9
|
0.6 grams
Interval 0.12 to 1.35
|
—
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: Participants completing the 38 week food challenge assessment were included in the analysis of primary outcome which was change in the cumulative tolerated dose during food challenge from baseline to week 38.
The percentage of subjects reaching a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut at week 38
Outcome measures
| Measure |
Walnut Protein Powder
n=8 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
n=4 Participants
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Open-label Walnut Protein Powder
This is the open-label phase of active dosing following the blinded treatment protocol through week 38. Following treatment unblinding at week 38, subjects on active treatment continued on daily maintenance treatment and those on placebo crossed over to active therapy per study protocol. All subjects in the open-label dosing phase were continued until the end of study at week 298 unless early exit criteria satisfied or the subject discontinued from the study.
|
|---|---|---|---|
|
Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Walnut Protein at Desensitization OFC at Week 38
|
6 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: Participants completing the week 38 food challenge assessment
Comparison of the number and percentage of subjects in each treatment arm reaching a cumulative protein dose of 2000mg at the week 38 (desensitization) oral food challenge to test tree nut
Outcome measures
| Measure |
Walnut Protein Powder
n=8 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
n=4 Participants
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Open-label Walnut Protein Powder
This is the open-label phase of active dosing following the blinded treatment protocol through week 38. Following treatment unblinding at week 38, subjects on active treatment continued on daily maintenance treatment and those on placebo crossed over to active therapy per study protocol. All subjects in the open-label dosing phase were continued until the end of study at week 298 unless early exit criteria satisfied or the subject discontinued from the study.
|
|---|---|---|---|
|
Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Test Tree Nut Protein at Desensitization OFC at Week 38
|
6 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 298 weeks on active treatmentPopulation: Those reaching sustained unresponsiveness to walnut and the test tree nut during open-label treatment by the end of study at week 298.
The percentage of subjects demonstrating sustained unresponsiveness to walnut and to the test tree nut by end of study. Analysis group combines both active and placebo-crossover participants during open-label extension arm through the end of study at week 298. Subjects were able to exit the study at assessment timepoints earlier than week 298 if they are able to pass the sustained unresponsiveness oral food challenge, thus the analysis included all subjects through week 298..
Outcome measures
| Measure |
Walnut Protein Powder
n=11 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Open-label Walnut Protein Powder
This is the open-label phase of active dosing following the blinded treatment protocol through week 38. Following treatment unblinding at week 38, subjects on active treatment continued on daily maintenance treatment and those on placebo crossed over to active therapy per study protocol. All subjects in the open-label dosing phase were continued until the end of study at week 298 unless early exit criteria satisfied or the subject discontinued from the study.
|
|---|---|---|---|
|
Number (Percentage) of Subjects Attaining Sustained Unresponsiveness to Walnut and Test Tree Nut Proteins at Week 298 Oral Food Challenge
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 142 weeksPopulation: Population analyzed combines active and placebo-crossover participants in the open-label phase of active walnut OIT. Change in skin test wheal size was measured from baseline to week 142 on active therapy. Baseline was defined for each arm as start of active treatment (active day=day 1; placebo arm (placebo cross-over)=week 38 (at start of active treatment period).
Evaluation of walnut OIT on the mast cell responses as measured through change in skin prick testing to walnut in participants who were treated with walnut OIT to week 142. Analysis group combines both active and placebo-crossover participants from baseline through open-label treatment phase until the end of study.
Outcome measures
| Measure |
Walnut Protein Powder
n=9 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Open-label Walnut Protein Powder
This is the open-label phase of active dosing following the blinded treatment protocol through week 38. Following treatment unblinding at week 38, subjects on active treatment continued on daily maintenance treatment and those on placebo crossed over to active therapy per study protocol. All subjects in the open-label dosing phase were continued until the end of study at week 298 unless early exit criteria satisfied or the subject discontinued from the study.
|
|---|---|---|---|
|
Change in Skin Prick Test Wheal Size From Baseline to Week 142 in Active and Placebo Cross-over Subjects Receiving Active Walnut OIT
|
3.4 mm wheal size
Interval 0.8 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 298 weeks active treatmentPopulation: All participants from study enrollment through blinded treatment phase at week 38, to open-label treatment through until exit of study, up to week 298.
Incidence of treatment-related serious adverse events during the study
Outcome measures
| Measure |
Walnut Protein Powder
n=10 Participants
146 weeks for active treatment subjects
Walnut Protein Powder: Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
Oat Powder
n=4 Participants
184 weeks for placebo
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
|
Open-label Walnut Protein Powder
n=13 Participants
This is the open-label phase of active dosing following the blinded treatment protocol through week 38. Following treatment unblinding at week 38, subjects on active treatment continued on daily maintenance treatment and those on placebo crossed over to active therapy per study protocol. All subjects in the open-label dosing phase were continued until the end of study at week 298 unless early exit criteria satisfied or the subject discontinued from the study.
|
|---|---|---|---|
|
Serious Adverse Events Related to Walnut OIT Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Walnut Protein Powder
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Oat Powder
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Open-Label Walnut Protein Powder
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Walnut Protein Powder
n=10 participants at risk
38 weeks for active treatment subjects
Walnut Protein Powder: Blinded study product dosing begins with a one-day oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks).
|
Oat Powder
n=4 participants at risk
38 weeks for placebo treatment subjects
Oat Powder (placebo): Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at \~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks).
|
Open-Label Walnut Protein Powder
n=13 participants at risk
Open-label treatment up to 298 weeks of active treatment
Unblinding to treatment assignment occurs at week 38, and active treatment subjects continue on open-label, daily maintenance dosing for up to a total of 298 weeks of active therapy. Placebo subjects are crossed over to open-label, active treatment beginning using the dosing protocol for active treatment with OFC at week 38. Active treatment for all subjects is up to week 298. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
|
|---|---|---|---|
|
Infections and infestations
Concurrent illness/condition - not dose-related
|
30.0%
3/10 • Number of events 6 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
25.0%
1/4 • Number of events 3 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
84.6%
11/13 • Number of events 98 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Immune system disorders
Pre-existing disease or condition - not dose-related
|
0.00%
0/10 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Product Issues
Concomitant medication - dose-related
|
0.00%
0/10 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/13 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Gastrointestinal disorders
Abdominal pain - not dose-related
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
General disorders
nasal congestion - dose-related
|
40.0%
4/10 • Number of events 5 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Skin and subcutaneous tissue disorders
flushing - dose related
|
10.0%
1/10 • Number of events 13 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
23.1%
3/13 • Number of events 7 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Respiratory, thoracic and mediastinal disorders
cough - dose-related
|
70.0%
7/10 • Number of events 12 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Gastrointestinal disorders
abdominal pain - dose-related
|
70.0%
7/10 • Number of events 22 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
46.2%
6/13 • Number of events 22 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Respiratory, thoracic and mediastinal disorders
throat tightness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea/sneezing - dose related
|
20.0%
2/10 • Number of events 7 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
30.8%
4/13 • Number of events 6 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Gastrointestinal disorders
mouth pruritus - dose-related
|
60.0%
6/10 • Number of events 17 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
38.5%
5/13 • Number of events 11 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Skin and subcutaneous tissue disorders
Hives - dose-related
|
30.0%
3/10 • Number of events 12 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
15.4%
2/13 • Number of events 4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Gastrointestinal disorders
vomiting - dose-related
|
10.0%
1/10 • Number of events 4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
15.4%
2/13 • Number of events 3 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
|
Respiratory, thoracic and mediastinal disorders
Throat discomfort/pruritus
|
40.0%
4/10 • Number of events 50 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
0.00%
0/4 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
53.8%
7/13 • Number of events 14 • Adverse events were collected from first participant enrollment (April 2012) through last participant exit visit (May 2018). Maximum total engagement in the study for each participant was 298 weeks of active treatment (~6 years); however, study discontinuation could occur yearly depending on study outcome measures reached for each participant.
SAE's are defined as per clinicaltrials.gov AE's included all events that were unrelated and related to OIT dosing with symptoms occurring within 2 hours of dosing or 2 hours after conclusion of study procedures (DPBCFC). Home OIT dose-related events, and treatment provided, were captured by daily, handwritten diary reporting by parents/participants AEs reported reflect entire trial with active and placebo-crossover subjects reported during blinded and open label stages
|
Additional Information
Dr. Stacie Jones
University of Arkansas for Medical Sciences
Phone: (501) 364-1060
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place