Trial Outcomes & Findings for Boiled Peanut Oral Immunotherapy (NCT NCT04090203)
NCT ID: NCT04090203
Last Updated: 2024-09-19
Results Overview
The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
18 weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Boiled Peanut Powder
Boiled Peanut Powder
Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Boiled Peanut Oral Immunotherapy
Baseline characteristics by cohort
| Measure |
Boiled Peanut Powder
n=8 Participants
Boiled Peanut Powder
Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.
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|---|---|
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Age, Categorical
<=18 years
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8 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: All participants who enrolled in the study.
The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval.
Outcome measures
| Measure |
Boiled Peanut Powder
n=8 Participants
Boiled Peanut Powder
Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.
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|---|---|
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Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.
|
75 percentage of participants
Interval 40.0 to 100.0
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Adverse Events
Boiled Peanut Powder
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Boiled Peanut Powder
n=8 participants at risk
Boiled Peanut Powder
Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.
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|---|---|
|
Immune system disorders
Anaphylaxis - Hives; redness and swelling of eyes; cough; difficulty breathing
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing and wheezing
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Globus sensation; audible change in voice; dysphagia
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
Other adverse events
| Measure |
Boiled Peanut Powder
n=8 participants at risk
Boiled Peanut Powder
Boiled Peanut Powder: Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
|
37.5%
3/8 • Number of events 9 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain, Diarrhea
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Abdominal Pain, Facial Flushing, Head Pain, Pruritus, Malaise
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain, Non-Cardiac Chest Pain
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain, Upset Stomach, Reflux
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Belching
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Cough, Urticaria, Lip/Mouth Pruritus, Vomiting
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough, Wheezing
|
37.5%
3/8 • Number of events 3 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
2/8 • Number of events 8 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Eczema, Pruritus
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema, Pruritus
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Skin and subcutaneous tissue disorders
Eyelid Dysfunction (Redness/Swelling)
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Facial Rash, Mucositis Oral
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Infections and infestations
Fever, Vomiting
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Lip/Mouth Pruritus
|
12.5%
1/8 • Number of events 48 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Lip/Mouth Pruritus, Abdominal Pain, Throat Pruritus
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Lip/Mouth Pruritus, Eye Pruritus, Vomiting
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Lip/Mouth Pruritus, Nausea
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Lip/Mouth Pruritus, Rash Maculo-Papular
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Lip/Mouth Pruritus, Throat Pruritus
|
12.5%
1/8 • Number of events 2 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Lip/Mouth Pruritus, Throat Pruritus, Nausea
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Nasal Congestion, Urticaria
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 6 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8 • Number of events 3 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Pruritus, Cough
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
General disorders
Rhinitis
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
General disorders
Rhinitis, Nasal Congestion
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
25.0%
2/8 • Number of events 2 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Ear and labyrinth disorders
Serous Otitis
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Throat Pruritus
|
12.5%
1/8 • Number of events 11 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Urticaria
|
25.0%
2/8 • Number of events 2 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Urticaria, Cough
|
12.5%
1/8 • Number of events 2 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Urticaria, Eye Pruritus, Nasal Congestion
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Urticaria, Periorbital Edema
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Urticaria, Rash Maculo-Papular
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 7 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Vomiting, Abdominal Pain
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Gastrointestinal disorders
Vomiting, Nasal Congestion, Chest Wall Pain
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
|
Immune system disorders
Vomiting, Urticaria
|
12.5%
1/8 • Number of events 1 • All reportable events will be recorded with start dates occurring any time after informed consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation could last for a maximum of up to 35 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place