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Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01274429
First received: January 9, 2011
Last updated: March 21, 2014
Last verified: March 2014

January 9, 2011
March 21, 2014
December 2010
September 2016   (final data collection date for primary outcome measure)
To treat peanut-allergic subjects with POIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01274429 on ClinicalTrials.gov Archive Site
To determine the effect that POIT has on the peanut-specific cellular and humoral response in peanut-allergic subjects. [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults
Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This is a research study to test stimulation of the immune system to improve peanut allergy. The approach the investigators will use for peanut allergy is called desensitization. A person becomes desensitized to a food by taking small, increasing amounts of the food to help the body become used to the food so that it no longer causes a severe allergic reaction.

The study also looks at the safety and immune system effects of the investigational study product, peanut protein. The word "investigational" means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

This project is designed to study if peanut oral immunotherapy (POIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance.

Not Provided
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peanut Allergy
Drug: powdered peanut protein
Active peanut allergy will be confirmed in all subjects with Double Blind Placebo Controlled Food Challenge (DBPCFC) 2 gm peanut protein oral food challenge prior to entry into the study. Oral desensitization begins with the modified rush. The first dose is 0.1 mg of peanut protein, the dose is doubled every 30 minutes until a maximum of 6 mg of peanut protein. The daily dose will be given at home until the scheduled escalation visit. Subjects return for escalation visits in the Food Allergy Study Center (FACS) every two weeks. The maintenance phase begins once the subject reaches 2300mg. This dose is taken daily. The maintenance phase begins once the subject reaches 2300mg which they take daily at home. All subjects will have a Double-Blind Placebo-Controlled Food Challenge (DBPCFC) at the end of 18 months of POIT to assess for desensitization.
Experimental: Peanut protein
Intervention: Drug: powdered peanut protein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
September 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 to 50 years of age of any gender, race, or ethnicity.
  • Diagnosis of peanut allergy OR convincing clinical history of peanut allergy.
  • Detectable serum peanut -specific Immune globin E(IgE) level (CAP-FEIA ≥ 0.35 kU/L) and a positive skin prick test (SPT) to peanut.
  • Participant willing to use effective method of contraception if female for the duration of the study, not pregnant or lactating, and not planning to become pregnant.
  • Positive reaction to ≤ 2 gm peanut protein on entry challenge.

Exclusion Criteria:

  • History of severe anaphylaxis to peanut per current National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) allergic reaction toxicity grading.
  • Known sensitivity or intolerance to Oats.
  • FEV1 value <80% predicted or any clinical features of moderate or persistent asthma per 2007 National Heart Lung and Blood Institute (NHLBI) guidelines.
  • Exacerbation of asthma in the past year requiring hospitalization or greater than 1 emergency department (ED) visit for asthma in the past 6 months.
  • Use Beta-blockers, ACE inhibitors, angiotensin receptor blocker (ARB) , or calcium channel blockers, xolair, or immunological treatments.
  • Uncontrolled hypertension per JNC 7 Guidelines (BP > 145/95 seated readings on each of two or more office visits).
  • Active eosinophilic gastrointestinal disease which could be exacerbated by peanut oral immunotherapy.
  • Chronic diseases such as diabetes, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, blood disorders, or history of ischemic cardiovascular disease, or other conditions that in the opinion of the Investigator make the subject unsuitable for induction of food allergy reactions.
  • Unable to speak English.
  • Inability to discontinue antihistamines prior to food challenges and skin prick tests.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01274429
Pro00023033
Yes
Wesley Burks, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Wesley Burks, MD Duke University
University of North Carolina, Chapel Hill
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP