Trial Outcomes & Findings for Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study (NCT NCT03345160)

NCT ID: NCT03345160

Last Updated: 2021-10-29

Results Overview

Number of participants who reported symptoms which were collected as AEs using CTCAE v4.0.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: up to 52 weeks
• Results posted on: 2021-10-29

Participant Flow

Participant milestones

Measure	Peanut Flour: Open Label Peanut OIT This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut oral immunotherapy (OIT) study Peanut Flour: open label oral immunotherapy
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study

Baseline characteristics by cohort

Measure	Peanut Flour: Open Label Peanut OIT n=7 Participants This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study Peanut Flour: open label oral immunotherapy
Age, Categorical <=18 years	7 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	7.6 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 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	6 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	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 52 weeks

Number of participants who reported symptoms which were collected as AEs using CTCAE v4.0.

Outcome measures

Measure	Peanut Flour: Open Label Peanut OIT n=7 Participants This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study Peanut Flour: open label oral immunotherapy
Number of Participants With Treatment-related Adverse Events (AEs)	7 Participants

SECONDARY outcome

Timeframe: up to 52 weeks

Population: Data reported for each participant.

This measure assessed the amount of peanut protein [in milligrams (mg)] tolerated by each participant at the end-of-treatment peanut challenge.

Outcome measures

Measure	Peanut Flour: Open Label Peanut OIT n=7 Participants This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study Peanut Flour: open label oral immunotherapy
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge Participant 1	4000 mg
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge Participant 2	4000 mg
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge Participant 3	4000 mg
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge Participant 4	4000 mg
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge Participant 5	4000 mg
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge Participant 6	4000 mg
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge Participant 7	2000 mg

Adverse Events

Peanut Flour: Open Label Peanut OIT

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Peanut Flour: Open Label Peanut OIT n=7 participants at risk This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study Peanut Flour: open label oral immunotherapy
General disorders Mild allergic reaction-Initial Dose Escalation	57.1% 4/7 • Number of events 4 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
General disorders Mild allergic reaction-Dosing related	100.0% 7/7 • Number of events 158 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Gastrointestinal disorders Gastroenteritis	14.3% 1/7 • Number of events 3 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	14.3% 1/7 • Number of events 5 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders influenza	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Ear and labyrinth disorders Otitis Media	42.9% 3/7 • Number of events 3 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders Rhinitis	28.6% 2/7 • Number of events 3 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
General disorders Fever	28.6% 2/7 • Number of events 6 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Number of events 3 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Eye disorders Allergic Conjunctivitis	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Skin and subcutaneous tissue disorders Eczema Flare	28.6% 2/7 • Number of events 4 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Gastrointestinal disorders Vomiting-not associated with dosing	42.9% 3/7 • Number of events 4 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders Strept Throat	14.3% 1/7 • Number of events 2 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
General disorders Nausea-not associated with dosing	28.6% 2/7 • Number of events 4 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders Pneumonia	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Musculoskeletal and connective tissue disorders Wrist Fracture	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
General disorders Allergic Reaction -not related to dosing	14.3% 1/7 • Number of events 2 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders Sinusitis	28.6% 2/7 • Number of events 3 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Ear and labyrinth disorders Otitis Externa	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Musculoskeletal and connective tissue disorders Back pain-related to a fall	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Skin and subcutaneous tissue disorders Rash-not related to dosing	14.3% 1/7 • Number of events 2 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
General disorders Dehydration	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Gastrointestinal disorders GERD-not related to dosing	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Respiratory, thoracic and mediastinal disorders Sore Throat	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • 52 weeks All 7 subjects reported mild symptoms with at least one IP administration. These reactions were collected and reported as AEs. These allergic reactions were expected.

Additional Information

Dr. Robert Wood

Johns Hopkins School of Medicine

Phone: 410-919-7617

Email: RWood@JHMI.edu

Results disclosure agreements

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