Trial Outcomes & Findings for The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery (NCT NCT02103270)

Results Overview

Number of Participants with No Clinical Reactivity to Peanuts

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

Week 117 - Number of participants with no clinical reactivity to peanuts

Results posted on

2019-09-04

Participant Flow

All arms undergo an Initial Dose Escalation (IDE) Day and updosing regimen with a maintenance phase of OIT or placebo to a maximum of 4,000 mg protein daily, as peanut flour, in the OIT groups, and to a maximum of an equivalent amount of oat flour for the placebo group.

At Week 104, individuals that reach criteria will, based on the randomization, either stop therapy with peanut and be switched to oat flour or will maintain on 300 mg peanut protein per day and all placebo subjects decreased to the equivalent volume of oat flour to optimize the blind. All subjects were evaluated every 13 weeks with DBPCFCs.

Participant milestones

Participant milestones
Measure	Peanut-4000 Oral immunotherapy with peanut discontinuation arm	Peanut-300 Oral immunotherapy with low dose peanut continuation arm	Placebo Comparator: Oat Flour 600 mg Placebo received oat flour
Overall Study STARTED	60	35	25
Overall Study COMPLETED	51	29	1
Overall Study NOT COMPLETED	9	6	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peanut 4000 n=60 Participants Oral immunotherapy with peanut discontinuation arm	Peanut 300 n=35 Participants Oral immunotherapy with low dose peanut continuation arm.	Placebo Comparator: Oat Flour 600 mg n=25 Participants Placebo received oat flour	Total n=120 Participants Total of all reporting groups
Age, Continuous	10 years n=5 Participants	11 years n=7 Participants	11 years n=5 Participants	11 years n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	23 Participants n=7 Participants	19 Participants n=5 Participants	81 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	34 Participants n=7 Participants	24 Participants n=5 Participants	109 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	60 participants n=5 Participants	35 participants n=7 Participants	25 participants n=5 Participants	120 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 117 - Number of participants with no clinical reactivity to peanuts

Number of Participants with No Clinical Reactivity to Peanuts

Outcome measures

Outcome measures
Measure	Peanut 4000 n=60 Participants Oral immunotherapy with peanut discontinuation arm	Peanut 300 n=35 Participants Oral immunotherapy with low dose peanut continuation arm.	Placebo Comparator: Oat Flour 600 mg n=25 Participants Placebo received oat flour
Passing the Week 117 DBPCFC to Peanut	21 participants	19 participants	1 participants

SECONDARY outcome

Timeframe: Week 130

Secondary endpoint: Passing the DBPCFC to peanut at 130 weeks

Outcome measures

Outcome measures
Measure	Peanut 4000 n=60 Participants Oral immunotherapy with peanut discontinuation arm	Peanut 300 n=35 Participants Oral immunotherapy with low dose peanut continuation arm.	Placebo Comparator: Oat Flour 600 mg n=25 Participants Placebo received oat flour
Passing the DBPCFC to Peanut at Week 130	12 participants	15 participants	1 participants

Adverse Events

Peanut-4000

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Peanut-300

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Comparator: Oat Flour 600 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peanut-4000 n=60 participants at risk Oral immunotherapy with peanut discontinuation arm	Peanut-300 n=35 participants at risk Oral immunotherapy with low dose peanut continuation arm	Placebo Comparator: Oat Flour 600 mg n=25 participants at risk Placebo received oat flour
Gastrointestinal disorders eosinophilic esophagitis	1.7% 1/60 • Number of events 1 • 2 years Safety outcomes determined by Common Terminology Criteria.	0.00% 0/35 • 2 years Safety outcomes determined by Common Terminology Criteria.	0.00% 0/25 • 2 years Safety outcomes determined by Common Terminology Criteria.
General disorders anaphylaxis with moderate hypotension	0.00% 0/60 • 2 years Safety outcomes determined by Common Terminology Criteria.	2.9% 1/35 • Number of events 1 • 2 years Safety outcomes determined by Common Terminology Criteria.	0.00% 0/25 • 2 years Safety outcomes determined by Common Terminology Criteria.

Other adverse events

Adverse event data not reported

Additional Information

Dr Andres Alvarez Pinzon, Director of Regulatory Affairs and Translational Medicine

The Sean N. Parker Center for Allergy Research at Stanford

Phone: 9544465645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place