Salvage Peanut Oral Immunotherapy Study

NCT03251508 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 17-0195
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization during a peanut immunotherapy trial.

Conditions

Peanut Allergy

Keywords

Peanut

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety)

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

  12 months

Secondary Outcomes (6)

• Percentage of Missed Doses During the 2-stage Study Sequence (Compliance)

  12 months

• Percentage of Participants Experiencing Treatment-emergent Adverse Events During the Peanut Oral Immunotherapy Stage

  6 months

• Percentage of Missed Doses During the Peanut Oral Immunotherapy Stage

  6 months

• Percentage of Participants Utilizing Emergency Epinephrine Use During the 2-Stage Study Sequence (Safety)

  12 months

• Percentage of Participants Experiencing Gastrointestinal Adverse Events During the 2-stage Study Sequence (Safety)

  12 months

Study Arms (1)

Peanut OIT/dietary peanut

EXPERIMENTAL

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.

Drug: Peanut OIT

Interventions

Peanut OIT DRUG

Participants will be given increasing doses of the peanut flour as peanut oral immunotherapy (OIT) with increasing doses every 2 weeks over a period of 3 months up to a 300 mg target dose. This 300 mg peanut OIT maintenance dose is then continued daily for 3 months. Participants will then introduce dietary peanut of approximately 300 mg of peanut protein and continue daily ingestion for an additional 6 months.

Also known as: Peanut flour

Peanut OIT/dietary peanut

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut.
• Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from patient or parent/guardian (if \< 18 years) with participant's assent.

You may not qualify if:

• Current participation in an interventional study for peanut allergy
• History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
• Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
• Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2)
• Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
• Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions.
• Pregnancy or lactation.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Edwin Kim, MD, MS
• Organization: UNC Food Allergy Initiative

edwinkim@email.unc.edu

919-537-3193

Study Officials

• Edwin Kim, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 16, 2017
• Study Start: January 3, 2018
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: January 30, 2023
• Results First Posted: January 30, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)