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| ID | Type | Description | Link |
|---|---|---|---|
| FARE | Other Identifier | Food Allergy Research and Education |
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The purpose of this study is to determine if walnut oral immunotherapy can be used in participants allergic to tree nuts to reduce tree nut allergy and induce changes in the participant's immune system.
Randomized, placebo controlled, Phase 1-2 study conducted at Arkansas Children's Hospital Research Institute (ACHRI) in tree nut allergic participants, ages 6-45 years with randomization following a 2:1 (active:placebo) format. The overall objectives were to evaluate the efficacy of walnut oral immunotherapy (WOIT) for induction of desensitization to walnut (secondary outcome) and a test tree nut (primary outcome) when compared to placebo after 38 weeks of treatment as assessed by double-blind, placebo-controlled food challenges (DBPCFC) to walnut and a test tree nut in tree nut allergic participants (defined by allergic reaction to \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walnut Protein Powder | Experimental | 38 weeks on active walnut powder on blinded treatment phase |
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| Oat Powder | Placebo Comparator | 38 weeks on placebo (oat) powder during blinded treatment phase |
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| Open-label Walnut Protein Powder | Other | Open-label treatment with walnut protein powder up to week 298 of total treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walnut Protein Powder | Drug | Blinded study product dosing begins with a 1-day oral desensitization protocol to walnut for subjects in the active arm. Starting at 0.1 mg protein and increasing to a maximum of 6 mg or until allergic symptoms develop. Subjects continue daily dosing of blinded OIT (walnut) with build-up every 2 weeks to a maximum daily dose of 1500mg at week 34, followed by 4 weeks of daily maintenance dosing. OFC to walnut and second tree nut occurs at week 38 then treatment is unblinded and open-label maintenance dosing occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 38 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Desensitization to Walnut Protein as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 Oral Food Challenge | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie M Jones, MD | University of Arkansas for Medical Sciences / Arkansas Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19577283 | Background | Jones SM, Pons L, Roberts JL, Scurlock AM, Perry TT, Kulis M, Shreffler WG, Steele P, Henry KA, Adair M, Francis JM, Durham S, Vickery BP, Zhong X, Burks AW. Clinical efficacy and immune regulation with peanut oral immunotherapy. J Allergy Clin Immunol. 2009 Aug;124(2):292-300, 300.e1-97. doi: 10.1016/j.jaci.2009.05.022. Epub 2009 Jul 3. | |
| 19477496 |
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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.
Participants were recruited from allergy clinics, research databases and advertisement. Study recruitment occurred from April 2012 through September 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Walnut Protein Powder | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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. | Posted | Median | Inter-Quartile Range | grams | 38 weeks of therapy |
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Walnut Protein Powder | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concurrent illness/condition - not dose-related | Infections and infestations | not used | Systematic Assessment |
Small sample size High screen failure rate High level of oropharyngeal symptoms Anxiety resulting in early termination Dosing fatigue with daily dosing Requirement for multiple food challenges in multi-tree nut assessment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stacie Jones | University of Arkansas for Medical Sciences | (501) 364-1060 | JonesStacieM@uams.edu |
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| ID | Term |
|---|---|
| D021184 | Nut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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Subjects will be randomized in a 2:1 ratio to either active treatment (final dose 1500mg walnut protein (WP), n=20) or placebo (n=10). Subjects will do a 1-day desensitization to enable subjects to tolerate 6 mg of WP or placebo (initial day escalation). After the initial escalation day obtaining at least 1.5mg and up to 6mg of WP or placebo, dosing build-up will be every 2 wks thru dose 24 (34 wks). A maintenance dose will be given for 4 wks, then a 5g protein OFC to walnut & a 5g protein OFC to a 2nd tree nut (~38 wks), then the study will be unblinded. Placebo subjects that fail the OFC will cross-over to active treatment and escalate to 1500mg target dose. Subjects will be followed for 298 wks (~6 yrs) total on active treatment including an OFC (both on & off therapy) to walnut and 2nd tree nut at 142 wk & end of study. Subjects with reduced serum specific IgE to <5kU/L to walnut and 2nd tree nut at yearly visits before the end of study at 298 wks are eligible for a tolerance OFC.
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| Oat Powder (placebo) | Drug | Blinded study product dosing begins with a one-day oral desensitization protocol with placebo (oat) powder. Subjects in the placebo group will undergo the same protocol as those in the active group with placebo OIT dosing. Unblinding to treatment assignment will occur after the 38 week oral food challenge. Placebo subjects will cross-over to active, open-label treatment with walnut powder after the 38 week oral food challenge. beginning with initial escalation day, through build-up and maintenance dosing per the same protocol sequence as noted for active, walnut powder. Subjects will complete an oral food challenge to walnut and the second tree nut at week 38 then will continue on long-term, open-label maintenance dosing until the end of study using same protocol design. |
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| Open-label Walnut Protein Powder | Drug | Open-label treatment phase begins after the 38 week oral food challenge with unblinding of treatment assignment. For those on active treatment, daily maintenance dosing occurs for up to a total of 298 weeks. For those on placebo treatment, cross-over to active, open-label treatment occurs using the same active treatment protocol. Placebo-crossover subjects will complete an oral food challenge to walnut and the second tree nut at week 38 of active therapy then continue on long-term, open-label maintenance dosing until the end of study using same protocol design. All subjects may reach a qualifying IgE to walnut/second tree nut early and will undergo an OFCs on and 4 weeks off OIT. All subjects will have OFCs on and 4 weeks off OIT at week 142 and at week 298, unless both walnut/second tree nut OFCs are passed at previous OFC prompting addition of these foods into the diet. |
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| 38 weeks |
| Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Walnut Protein at Desensitization OFC at Week 38 | The percentage of subjects reaching a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut at week 38 | 38 weeks |
| Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Test Tree Nut Protein at Desensitization OFC at Week 38 | 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 | 38 weeks |
| Number (Percentage) of Subjects Attaining Sustained Unresponsiveness to Walnut and Test Tree Nut Proteins at Week 298 Oral Food Challenge | 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.. | up to 298 weeks on active treatment |
| Change in Skin Prick Test Wheal Size From Baseline to Week 142 in Active and Placebo Cross-over Subjects Receiving Active Walnut OIT | 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. | 142 weeks |
| Serious Adverse Events Related to Walnut OIT Treatment | Incidence of treatment-related serious adverse events during the study | 298 weeks active treatment |
| Hofmann AM, Scurlock AM, Jones SM, Palmer KP, Lokhnygina Y, Steele PH, Kamilaris J, Burks AW. Safety of a peanut oral immunotherapy protocol in children with peanut allergy. J Allergy Clin Immunol. 2009 Aug;124(2):286-91, 291.e1-6. doi: 10.1016/j.jaci.2009.03.045. Epub 2009 May 27. |
| 21093029 | Background | Kulis M, Li Y, Lane H, Pons L, Burks W. Single-tree nut immunotherapy attenuates allergic reactions in mice with hypersensitivity to multiple tree nuts. J Allergy Clin Immunol. 2011 Jan;127(1):81-8. doi: 10.1016/j.jaci.2010.09.014. Epub 2010 Nov 18. |
| 21377034 | Background | Varshney P, Jones SM, Scurlock AM, Perry TT, Kemper A, Steele P, Hiegel A, Kamilaris J, Carlisle S, Yue X, Kulis M, Pons L, Vickery B, Burks AW. A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response. J Allergy Clin Immunol. 2011 Mar;127(3):654-60. doi: 10.1016/j.jaci.2010.12.1111. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| subjects with asthma | Number | participants |
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| subjects with atopic dermatitis | Number | participants |
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| subjects with allergic rhinitis | Number | participants |
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| OG001 | 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. |
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| Secondary | Evaluation of Desensitization to Walnut Protein as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 Oral Food Challenge | 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. | 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. | Posted | Median | Inter-Quartile Range | grams | 38 weeks |
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| Secondary | Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Walnut Protein at Desensitization OFC at Week 38 | The percentage of subjects reaching a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut at week 38 | 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. | Posted | Count of Participants | Participants | 38 weeks |
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| Secondary | Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Test Tree Nut Protein at Desensitization OFC at Week 38 | 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 | Participants completing the week 38 food challenge assessment | Posted | Count of Participants | Participants | 38 weeks |
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| Secondary | Number (Percentage) of Subjects Attaining Sustained Unresponsiveness to Walnut and Test Tree Nut Proteins at Week 298 Oral Food Challenge | 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.. | Those reaching sustained unresponsiveness to walnut and the test tree nut during open-label treatment by the end of study at week 298. | Posted | Count of Participants | Participants | up to 298 weeks on active treatment |
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| Secondary | Change in Skin Prick Test Wheal Size From Baseline to Week 142 in Active and Placebo Cross-over Subjects Receiving Active Walnut OIT | 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. | 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). | Posted | Median | Inter-Quartile Range | mm wheal size | 142 weeks |
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| Secondary | Serious Adverse Events Related to Walnut OIT Treatment | Incidence of treatment-related serious adverse events during the study | 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. | Posted | Count of Participants | Participants | 298 weeks active treatment |
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| 0 |
| 10 |
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Oat Powder | 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). | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Open-Label Walnut Protein Powder | 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. | 0 | 13 | 0 | 13 | 11 | 13 |
| Pre-existing disease or condition - not dose-related | Immune system disorders | not used | Non-systematic Assessment |
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| Concomitant medication - dose-related | Product Issues | not used | Non-systematic Assessment | Dose-related, AE-related epinephrine use |
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| Abdominal pain - not dose-related | Gastrointestinal disorders | not used | Non-systematic Assessment |
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| nasal congestion - dose-related | General disorders | not used | Non-systematic Assessment |
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| flushing - dose related | Skin and subcutaneous tissue disorders | not used | Non-systematic Assessment | Symptoms related to OIT dose |
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| cough - dose-related | Respiratory, thoracic and mediastinal disorders | not used | Non-systematic Assessment | Symptoms related to OIT dose |
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| abdominal pain - dose-related | Gastrointestinal disorders | not used | Non-systematic Assessment |
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| throat tightness | Respiratory, thoracic and mediastinal disorders | not used | Non-systematic Assessment | Symptoms related to OIT dose |
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| rhinorrhea/sneezing - dose related | Respiratory, thoracic and mediastinal disorders | not used | Non-systematic Assessment | Symptoms related to OIT dose |
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| mouth pruritus - dose-related | Gastrointestinal disorders | not used | Non-systematic Assessment | Symptoms related to OIT dose |
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| Hives - dose-related | Skin and subcutaneous tissue disorders | not used | Non-systematic Assessment | Symptoms related to OIT dose |
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| vomiting - dose-related | Gastrointestinal disorders | not used | Non-systematic Assessment | Symptoms related to OIT dose |
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| Throat discomfort/pruritus | Respiratory, thoracic and mediastinal disorders | not used | Non-systematic Assessment | Symptoms related to dosing |
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