Your session is about to expire
← Back to Search
Peanut OIT for Peanut Allergy (SOIT Trial)
Phase 1 & 2
Waitlist Available
Led By Edwin Kim, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
SOIT Trial Summary
This trial is testing if a certain immunotherapy treatment can help people with peanut allergies who have lost sensitivity during another immunotherapy trial.
Eligible Conditions
- Peanut Allergy
SOIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety)
Secondary outcome measures
Percentage of Missed Doses During the 2-stage Study Sequence (Compliance)
Percentage of Missed Doses During the Peanut Oral Immunotherapy Stage
Percentage of Participants Experiencing Gastrointestinal Adverse Events During the 2-stage Study Sequence (Safety)
+3 moreSide effects data
From 2021 Phase 1 & 2 trial • 15 Patients • NCT0325150853%
Gastrointestinal adverse events
33%
Skin adverse events
20%
Upper respiratory adverse events
13%
Lower respiratory adverse events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Peanut OIT/Dietary Peanut
SOIT Trial Design
1Treatment groups
Experimental Treatment
Group I: Peanut OIT/dietary peanutExperimental Treatment1 Intervention
Single arm study with all subjects receiving peanut OIT study drug for the 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peanut OIT
2007
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,601 Total Patients Enrolled
Edwin Kim, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
152 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Share this study with friends
Copy Link
Messenger