Trial Outcomes & Findings for Food Allergen OIT for Shrimp and Cashew (NCT NCT03504774)
NCT ID: NCT03504774
Last Updated: 2024-03-26
Results Overview
Expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks, reported as the percentage of allergen specific (reactive) cells.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
baseline and 52 week
Results posted on
2024-03-26
Participant Flow
Participants with an allergy to Cashew or Shrimp were enrolled. The study was to examine the efficacy of oral immunotherapy regimen overtime, without comparisons between allergen groups.
58 participants consented and assessed for eligibility. 2 participants withdrew consent and 4 participants screen failed, and were not allocated to treatment.
Participant milestones
| Measure |
Cashew Oral Immunotherapy
Participants, ages 7 to 55 years, inclusive, with an allergy to Cashew, received updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo Double Blind-Placebo Controlled-Food Challenge (DBPCFC). After week 52, participants will avoid the allergen (withdrawal phase) for 6 weeks and will come back for DBPCFC at week 58.
|
Shrimp Oral Immunotherapy
Participants, ages 7 to 55 years, inclusive, with an allergy to Shrimp, received an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. After week 52, participants will avoid the allergen (withdrawal phase) for 6 weeks and will come back for DBPCFC at week 58.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
12
|
|
Overall Study
Enrolled for the Intention-to-Treat Analysis
|
40
|
12
|
|
Overall Study
Assigned to Build-up and Maintenance
|
40
|
12
|
|
Overall Study
Had Week 52 Desensitization DBPCFC
|
27
|
8
|
|
Overall Study
Had Week 58 Sustained Unresponsiveness DBPCFC
|
26
|
8
|
|
Overall Study
COMPLETED
|
26
|
8
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
| Measure |
Cashew Oral Immunotherapy
Participants, ages 7 to 55 years, inclusive, with an allergy to Cashew, received updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo Double Blind-Placebo Controlled-Food Challenge (DBPCFC). After week 52, participants will avoid the allergen (withdrawal phase) for 6 weeks and will come back for DBPCFC at week 58.
|
Shrimp Oral Immunotherapy
Participants, ages 7 to 55 years, inclusive, with an allergy to Shrimp, received an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. After week 52, participants will avoid the allergen (withdrawal phase) for 6 weeks and will come back for DBPCFC at week 58.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
11
|
3
|
|
Overall Study
failed wk 52 DBPCFC
|
1
|
0
|
Baseline Characteristics
Food Allergen OIT for Shrimp and Cashew
Baseline characteristics by cohort
| Measure |
Cashew Oral Immunotherapy
n=40 Participants
Participants with an allergy to Cashew.
|
Shrimp Oral Immunotherapy
n=12 Participants
Participants with an allergy to Shrimp.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Age, Continuous
|
14 years
n=113 Participants
|
23.5 years
n=163 Participants
|
14 years
n=160 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
27 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
25 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
46 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
22 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
18 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
9 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=113 Participants
|
12 Participants
n=163 Participants
|
52 Participants
n=160 Participants
|
|
History of Asthma
|
19 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
26 Participants
n=160 Participants
|
|
History of Allergic Rhinitis
|
28 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
37 Participants
n=160 Participants
|
|
History of Atopic Dermatitis
|
24 Participants
n=113 Participants
|
6 Participants
n=163 Participants
|
30 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: baseline and 52 weekPopulation: participants with baseline and week 52 CD28 expression data
Expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks, reported as the percentage of allergen specific (reactive) cells.
Outcome measures
| Measure |
Cashew Oral Immunotherapy
n=25 Participants
Participants with an allergy to Cashew.
|
Shrimp Oral Immunotherapy
n=8 Participants
Participants with an allergy to Shrimp.
|
All Participants
n=33 Participants
Participants with allergy to Cashew / Shrimp
|
|---|---|---|---|
|
Expression of CD28 in the CD4+ Allergen Specific (CD154+)
baseline
|
99 percentage of allergen reactive cells
Interval 88.7 to 100.0
|
98.9 percentage of allergen reactive cells
Interval 88.7 to 100.0
|
99 percentage of allergen reactive cells
Interval 88.7 to 100.0
|
|
Expression of CD28 in the CD4+ Allergen Specific (CD154+)
week 52
|
100 percentage of allergen reactive cells
Interval 95.5 to 100.0
|
97.7 percentage of allergen reactive cells
Interval 93.8 to 100.0
|
99.5 percentage of allergen reactive cells
Interval 93.8 to 100.0
|
SECONDARY outcome
Timeframe: baseline, week 52 and week 58Population: participants with baseline, week 52, or week 58 CD28 expression
Expression of CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58, reported as the percentage of allergen specific (reactive) cells.
Outcome measures
| Measure |
Cashew Oral Immunotherapy
n=25 Participants
Participants with an allergy to Cashew.
|
Shrimp Oral Immunotherapy
n=8 Participants
Participants with an allergy to Shrimp.
|
All Participants
n=33 Participants
Participants with allergy to Cashew / Shrimp
|
|---|---|---|---|
|
Expression of CD28+ Allergen Specific (CD154+) T-cells
baseline
|
99 percentage of allergen reactive cells
Interval 88.7 to 100.0
|
98.9 percentage of allergen reactive cells
Interval 88.7 to 100.0
|
99 percentage of allergen reactive cells
Interval 88.7 to 100.0
|
|
Expression of CD28+ Allergen Specific (CD154+) T-cells
week 52
|
100 percentage of allergen reactive cells
Interval 95.5 to 100.0
|
97.7 percentage of allergen reactive cells
Interval 93.8 to 100.0
|
99.5 percentage of allergen reactive cells
Interval 93.8 to 100.0
|
|
Expression of CD28+ Allergen Specific (CD154+) T-cells
week 58
|
100 percentage of allergen reactive cells
Interval 93.8 to 100.0
|
99.2 percentage of allergen reactive cells
Interval 93.0 to 100.0
|
100 percentage of allergen reactive cells
Interval 93.0 to 100.0
|
SECONDARY outcome
Timeframe: baseline, week 52, and week 58Population: participants who had baseline, week 52, or week 58 Luminex data
Expression of the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58. Data were collected for IFN-gamma, IL-4 and IL-10 via Luminex assay. Data collection was planned for receptor diversity in allergen specific T cell CDR3b as compared to non-specific T cells, and TGF beta, but these data were not collected. The median value (with full range) of mean fluorescence intensity across participants is reported for each time point.
Outcome measures
| Measure |
Cashew Oral Immunotherapy
n=27 Participants
Participants with an allergy to Cashew.
|
Shrimp Oral Immunotherapy
n=8 Participants
Participants with an allergy to Shrimp.
|
All Participants
n=35 Participants
Participants with allergy to Cashew / Shrimp
|
|---|---|---|---|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IL-4 at week 58
|
33.5 mean fluorescence intensity
Interval 18.0 to 86.0
|
30 mean fluorescence intensity
Interval 21.5 to 38.5
|
32.5 mean fluorescence intensity
Interval 18.0 to 86.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IL-10 at baseline
|
36.5 mean fluorescence intensity
Interval 21.0 to 52.0
|
36.5 mean fluorescence intensity
Interval 26.0 to 42.0
|
36.5 mean fluorescence intensity
Interval 21.0 to 52.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IL-10 at week 52
|
38.5 mean fluorescence intensity
Interval 26.5 to 75.0
|
38.5 mean fluorescence intensity
Interval 26.0 to 46.5
|
38.5 mean fluorescence intensity
Interval 26.0 to 75.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IFN-gamma at baseline
|
53 mean fluorescence intensity
Interval 42.0 to 134.0
|
53.8 mean fluorescence intensity
Interval 46.0 to 78.0
|
53 mean fluorescence intensity
Interval 42.0 to 134.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IFN-gamma at week 52
|
56 mean fluorescence intensity
Interval 33.5 to 128.0
|
61.2 mean fluorescence intensity
Interval 47.0 to 100.0
|
60 mean fluorescence intensity
Interval 33.5 to 128.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IFN-gamma at week 58
|
53 mean fluorescence intensity
Interval 33.0 to 248.0
|
58 mean fluorescence intensity
Interval 44.0 to 72.0
|
55 mean fluorescence intensity
Interval 33.0 to 248.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IL-4 at baseline
|
33 mean fluorescence intensity
Interval 18.0 to 55.0
|
30.2 mean fluorescence intensity
Interval 26.5 to 41.0
|
32 mean fluorescence intensity
Interval 18.0 to 55.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IL-4 at week 52
|
32 mean fluorescence intensity
Interval 15.0 to 74.0
|
34 mean fluorescence intensity
Interval 22.0 to 46.5
|
33 mean fluorescence intensity
Interval 15.0 to 74.0
|
|
Expression of the Mechanistic Markers Vis Luminex Assay
IL-10 at week 58
|
37 mean fluorescence intensity
Interval 29.0 to 61.0
|
36.2 mean fluorescence intensity
Interval 25.0 to 55.0
|
37 mean fluorescence intensity
Interval 25.0 to 61.0
|
SECONDARY outcome
Timeframe: baseline, week 52, and week 58Population: participants who had baseline, week 52, or week 58 Flow cytometry data
Expression of the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58. Data were collected for GPR15 via flow cytometry resulting in mean fluorescence intensity. Data collection was planned for receptor diversity in allergen specific T cell CDR3b as compared to non-specific T cells, and TGF beta, but these data were not collected. The median value (with full range) of mean fluorescence intensity across participants is reported for each time point.
Outcome measures
| Measure |
Cashew Oral Immunotherapy
n=24 Participants
Participants with an allergy to Cashew.
|
Shrimp Oral Immunotherapy
n=8 Participants
Participants with an allergy to Shrimp.
|
All Participants
n=32 Participants
Participants with allergy to Cashew / Shrimp
|
|---|---|---|---|
|
Expression of the Mechanistic Marker Via Flow Cytometry
GPR15 at baseline
|
1801 mean fluorescence intensity
Interval 0.0 to 39861.0
|
1585 mean fluorescence intensity
Interval 1402.0 to 5029.0
|
1664 mean fluorescence intensity
Interval 0.0 to 39861.0
|
|
Expression of the Mechanistic Marker Via Flow Cytometry
GPR15 at week 52
|
1778 mean fluorescence intensity
Interval 0.0 to 10041.0
|
1922 mean fluorescence intensity
Interval 1230.0 to 5616.0
|
1798 mean fluorescence intensity
Interval 0.0 to 10041.0
|
|
Expression of the Mechanistic Marker Via Flow Cytometry
GPR15 at week 58
|
1441 mean fluorescence intensity
Interval 0.0 to 33037.0
|
2715 mean fluorescence intensity
Interval 1251.0 to 32643.0
|
1609 mean fluorescence intensity
Interval 0.0 to 33037.0
|
Adverse Events
Cashew Oral Immunotherapy
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Shrimp Oral Immunotherapy
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cashew Oral Immunotherapy
n=40 participants at risk
Participants with an allergy to Cashew.
|
Shrimp Oral Immunotherapy
n=12 participants at risk
Participants with an allergy to Shrimp.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
Other adverse events
| Measure |
Cashew Oral Immunotherapy
n=40 participants at risk
Participants with an allergy to Cashew.
|
Shrimp Oral Immunotherapy
n=12 participants at risk
Participants with an allergy to Shrimp.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal Muscle Pain
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Injury, poisoning and procedural complications
ankle injury
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Injury, poisoning and procedural complications
Ankles and left knee hurt when running
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Atopic Dermatitis Flare
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Body Soreness
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Bump on cheek
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Bump on lip
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Blood and lymphatic system disorders
Cervical lymphadenopathy
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
25.0%
3/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Discomfort
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Ear and labyrinth disorders
Ear pressure
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Blood and lymphatic system disorders
enlarged lymph node - status post-vaccination
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Eye disorders
Conjunctivitis
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Eye disorders
Photophobia
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Injury, poisoning and procedural complications
Food poisoning
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Edema face
|
17.5%
7/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
16.7%
2/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Fatigue
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Fever
|
7.5%
3/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Abdominal pain
|
62.5%
25/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
25.0%
3/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
5/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
16.7%
2/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
10/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Gastroenteritis (Stomach flu)
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Itchy mouth/throat/lips/tongue
|
80.0%
32/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
66.7%
8/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Stomach pain
|
17.5%
7/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Toothache
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
7/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Heartburn (Acid Reflux)
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Gum Soreness
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Vascular disorders
Hand Swelling
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Infections and infestations
Otitis media
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Infections and infestations
Upper respiratory infection
|
22.5%
9/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
33.3%
4/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Infections and infestations
Wound infection
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Injury, poisoning and procedural complications
Burn
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Injury, poisoning and procedural complications
Fracture
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
itchy skin
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Ear and labyrinth disorders
itchy ears
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Eye disorders
itchy eyes
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Eye disorders
Itchy/Red/Eyes
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Musculoskeletal and connective tissue disorders
Jaw Tightness/Ache
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Lightheadedness
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Malaise
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Infections and infestations
Mild conjunctival infection
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
General disorders
Muscle Soreness
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
25.0%
3/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Psychiatric disorders
Agitation
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Psychiatric disorders
Depression
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
4/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
16.7%
2/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.0%
6/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
7.5%
3/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
25.0%
3/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal Allergies
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Eczema Flare
|
12.5%
5/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
16.7%
2/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Poison Oak
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
6/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
16.7%
2/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.5%
9/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
41.7%
5/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
17.5%
7/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
33.3%
4/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Sour taste/reflux
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Stomach Cramps due to Period
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Stomach discomfort
|
7.5%
3/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Stomach Discomfort (No Pain)
|
17.5%
7/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Respiratory, thoracic and mediastinal disorders
stuffy and runny nose
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Tenesmus
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Throat Discomfort
|
12.5%
5/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Throat Discomfort, Change in Breathing
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Throat Tingling
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
tingling sensation of mouth
|
0.00%
0/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
8.3%
1/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Musculoskeletal and connective tissue disorders
TMJ
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Tongue Tingling
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Transient lesion on tongue
|
5.0%
2/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Gastrointestinal disorders
Transient Throat Discomfort
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
|
Vascular disorders
Flushing
|
2.5%
1/40 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
0.00%
0/12 • 64 weeks (58 weeks of OIT and food challenge plus 6 weeks follow up)
|
Additional Information
Sayantani B. Sindher, MD
Stanford University School of Medicine
Phone: 650-521-7237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place