Mechanisms of Desensitization During Peanut Oral Immunotherapy

NCT01814241 | Completed Phase 2 Results DMC

• 2 other identifiers: 13-0900R01AI068074
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to attempt to understand how desensitization works in peanut allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify the early changes in the desensitization process the immune cells undergo to become desensitized to the peanut protein.

Conditions

Food Hypersensitivity

Keywords

Peanut allergy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Develop Desensitization

  The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.

  40 weeks

Secondary Outcomes (1)

• Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped

  4 weeks

Other Outcomes (3)

• Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut

  44 weeks

• Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge

  44 weeks

• Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge

  44 weeks

Study Arms (1)

Open label peanut OIT

EXPERIMENTAL

Open label orally ingested peanut flour with maintenance dose of 1450mg

Drug: Open label peanut OIT

Interventions

Open label peanut OIT DRUG

Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.

Also known as: Peanut flour

Open label peanut OIT

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4 to up to 12 years of age of any gender, race, or ethnicity.
• Minimum weight 16 kg at the time of enrollment.
• Physician diagnosis of peanut allergy OR convincing clinical history of an allergic reaction to peanut.
• Detectable serum peanut -specific IgE level (CAP-FEIA ≥ 0.35 kU/L) and a positive SPT (wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control.)
• Allergic reaction to ≤ 1 gm peanut protein during a blinded oral challenge test conducted at screening (e.g., a double-blinded, placebo-controlled food challenge \[DBPCFC\]).
• Written informed consent from parent/guardian.
• Written assent from subject if applicable
• Consumption of oat-containing product within 90 days prior to enrollment

You may not qualify if:

• History of allergic reaction to peanut consistent with severe anaphylaxis (defined as hypotension/shock; or neurologic impairment).
• Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes.
• Active eosinophilic gastrointestinal disease in the past 2 years
• Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1
• Inhalant allergen immunotherapy that has not yet reached maintenance dosing.
• Asthma defined as moderate or severe persistent by National Asthma Education and Prevention Program Expert Panel Guidelines (e.g. asthma that requires more than fluticasone 440 mcg or its equivalent daily for adequate control).
• Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation.
• Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1.
• Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, Systemic corticosteroid therapy of up to a total of three weeks is allowed.
• Use of investigational drug in 90 days prior to visit -1.
• Plan to use any investigational drug during the study period.
• The presence of any medical condition that the investigator deems incompatible with participation in the trial.
• Inability to speak English.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Edwin Kim, Director of the UNC Food Allergy Initiative
• Organization: University of North Carolina at Chapel Hill

edwinkim@email.unc.edu

919-843-9087

Study Officials

• Wesley Burks, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• Edwin Kim, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 1, 2018
• Results First Posted: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)