Trial Outcomes & Findings for Salvage Peanut Oral Immunotherapy Study (NCT NCT03251508)

NCT ID: NCT03251508

Last Updated: 2023-01-30

Results Overview

Percentage of participants experiencing an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut ingestion

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-01-30

Participant Flow

Participant milestones

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut Subjects receiving peanut flour oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Peanut Oral Immunotherapy (Months 1-6) STARTED	15
Peanut Oral Immunotherapy (Months 1-6) COMPLETED	11
Peanut Oral Immunotherapy (Months 1-6) NOT COMPLETED	4
Dietary Peanut (Months 7-12) STARTED	11
Dietary Peanut (Months 7-12) COMPLETED	10
Dietary Peanut (Months 7-12) NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Salvage Peanut Oral Immunotherapy Study

Baseline characteristics by cohort

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=15 Participants Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Age, Categorical <=18 years	15 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6.9 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 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	0 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	15 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	15 Participants n=5 Participants
Prior Immunotherapy Study Peanut Oral Immunotherapy (OIT)	5 Participants n=5 Participants
Prior Immunotherapy Study Peanut Sublingual Immunotherapy (SLIT)	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Percentage of participants experiencing an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut ingestion

Outcome measures

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=15 Participants Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety)	60 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Evaluation of patient compliance with a 2-stage peanut oral immunotherapy (OIT) and dietary peanut protocol as measured by the percentage of doses missed over the entire 2-stage study protocol sequence.

Outcome measures

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=5103 immunotherapy & dietary peanut doses Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Percentage of Missed Doses During the 2-stage Study Sequence (Compliance)	1.2 percentage of missed doses

SECONDARY outcome

Timeframe: 6 months

Evaluation of peanut oral immunotherapy (OIT) safety measured by the percentage of participants experiencing an adverse event related to peanut OIT during the peanut oral immunotherapy (OIT) stage of the 2-stage Peanut Oral Immunotherapy/Dietary Peanut protocol.

Outcome measures

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=15 Participants Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Percentage of Participants Experiencing Treatment-emergent Adverse Events During the Peanut Oral Immunotherapy Stage	60 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Evaluation of patient compliance measured by the percentage of doses missed during the peanut oral immunotherapy (OIT) stage of the 2-stage Peanut Oral Immunotherapy/Dietary Peanut protocol.

Outcome measures

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=2863 oral immunotherapy doses Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Percentage of Missed Doses During the Peanut Oral Immunotherapy Stage	2.1 percentage of missed doses

SECONDARY outcome

Timeframe: 12 months

Percentage of participants utilizing epinephrine for treatment of an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut

Outcome measures

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=15 Participants Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Percentage of Participants Utilizing Emergency Epinephrine Use During the 2-Stage Study Sequence (Safety)	0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Percentage of participants experiencing a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut

Outcome measures

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=15 Participants Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Percentage of Participants Experiencing Gastrointestinal Adverse Events During the 2-stage Study Sequence (Safety)	53.33 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Percentage of participants withdrawing from the study due to a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut

Outcome measures

Measure	Open-label Peanut Oral Immunotherapy/Dietary Peanut n=15 Participants Subjects receiving peanut oral immunotherapy (OIT) up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Percentage of Participants Withdrawing During the 2-stage Study Sequence Due to Gastrointestinal Adverse Events (Safety)	13.33 percentage of participants

Adverse Events

Open-label Peanut OIT/Dietary Peanut

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open-label Peanut OIT/Dietary Peanut n=15 participants at risk Subjects receiving peanut OIT up to maintenance dose of 300 mg over initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.
Skin and subcutaneous tissue disorders Skin adverse events	33.3% 5/15 • Adverse events were captured from the time of signing consent through the completion of 12 month treatment protocol. Dose escalation symptoms were recorded by study coordinators. Home OIT and dietary peanut symptoms were reported by parents through home diaries.
Respiratory, thoracic and mediastinal disorders Upper respiratory adverse events	20.0% 3/15 • Adverse events were captured from the time of signing consent through the completion of 12 month treatment protocol. Dose escalation symptoms were recorded by study coordinators. Home OIT and dietary peanut symptoms were reported by parents through home diaries.
Respiratory, thoracic and mediastinal disorders Lower respiratory adverse events	13.3% 2/15 • Adverse events were captured from the time of signing consent through the completion of 12 month treatment protocol. Dose escalation symptoms were recorded by study coordinators. Home OIT and dietary peanut symptoms were reported by parents through home diaries.
Gastrointestinal disorders Gastrointestinal adverse events	53.3% 8/15 • Adverse events were captured from the time of signing consent through the completion of 12 month treatment protocol. Dose escalation symptoms were recorded by study coordinators. Home OIT and dietary peanut symptoms were reported by parents through home diaries.

Additional Information

Edwin Kim, MD, MS

UNC Food Allergy Initiative

Phone: 919-537-3193

Email: edwinkim@email.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place