FARE Peanut SLIT and Early Tolerance Induction

NCT02304991 | Completed Phase 2 Results DMC

• 2 other identifiers: 14-0648R01AT004435-07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. \[Time Frame: Baseline, 36 months\] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. \[Time Frame: Baseline, 39 months\]

Conditions

Peanut Hypersensitivity; Food Allergy; Food Hypersensitivity; Peanut Allergy

Keywords

Peanut; Food Allergy

Outcome Measures

Primary Outcomes (1)

• Desensitization After 36 Months of Peanut SLIT or Placebo SLIT

  The primary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during DBPCFC after 36 months of peanut SLIT (desensitization). DBPCFC Challenge Score scale: Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7.

  36 months

Secondary Outcomes (5)

• Tolerance 3 Months After Discontinuing Peanut SLIT or Placebo SLIT

  39 months

• Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgE)

  0 months to 36 months

• Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgG4)

  0 months to 36 months

• Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut Skin Prick Test)

  0 months to 36 months

• Number of Participants Experiencing Serious Adverse Events With Peanut SLIT Versus Placebo SLIT

  39 months

Study Arms (2)

Peanut (liquid peanut extract) SLIT

EXPERIMENTAL

After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.

Drug: Liquid Peanut Extract

Placebo Glycerin SLIT

PLACEBO COMPARATOR

After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.

Drug: Placebo Glycerin SLIT

Interventions

Liquid Peanut Extract DRUG

5000mcg/ml peanut protein

Also known as: SLIT

Peanut (liquid peanut extract) SLIT

Placebo Glycerin SLIT DRUG

pure glycerinated saline solution with caramel coloring to match color

Also known as: SLIT

Placebo Glycerin SLIT

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent from participant's parent/guardian.
• Age 12-48 months of either sex, any race, any ethnicity.
• A peanut allergy diagnosis with a convincing clinical history of peanut allergy and a serum peanut-specific IgE \[UniCAP\] \> 0.35 kUA/L AND a positive skin prick test to peanut (\>3 mm than the negative control) OR are sensitized to peanut (based on a serum IgE \[UniCAP\] to peanut of \> 5 kUA/L) AND a positive skin prick test to peanut (\> 3 mm than the negative control) and no known history of ingestion of peanut.
• A positive DBPCFC to 1000 mg of peanut at enrollment.

You may not qualify if:

• History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or peripheral capillary oxygen saturation (SpO2) \< 92% at any stage, hypotension, confusion, collapse or loss of consciousness).
• Participation in any interventional study for the treatment of food allergy in the past 6 months.
• Known oat, wheat, or glycerin allergy.
• Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease.
• Severe asthma (2007 NHLBI Criteria Steps 5 or 6 - Appendix 2).
• Inability to discontinue antihistamines for skin testing and DBPCFCs.
• Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year.
• Use of beta-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 make the subject unsuitable for induction of food reactions.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Food Allergy Research & Education: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Edwin Kim, MD, MS
• Organization: University of North Carolina School of Medicine

edwinkim@email.unc.edu

919-962-4960

Study Officials

• Wesley Burks, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 10, 2022
• Results First Posted: December 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)