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The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery (POISED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103270
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Kari Christine Nadeau, MD PhD, Stanford University

Brief Summary:

Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period

Secondary Objectives:

  • Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals.
  • Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Peanut Protein 4,000mg Drug: Oat Flour Drug: Peanut Protein 300 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Single Center, Placebo Controlled Clinical Study in Desensitization vs Tolerance Induction in Peanut Allergy Subjects
Actual Study Start Date : April 2014
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Placebo Comparator: Oat Flour 600 mg
Arm C that is maintained on placebo (oat flour) throughout the study; this arm will receive 600 mg oat flour beginning on week 104. This will be true even if a subject in the placebo group meets criteria at week 104
Drug: Oat Flour
Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).

Active Comparator: Peanut Protein 4,000mg
Arm A on peanut OIT until week 104 (maintenance) and once meeting criteria [i.e. 1) on OIT treatment for minimum 104 weeks, 2) taking daily maintenance dose of 4,000 mg protein for at least 13 weeks, 3) no severe reactions to home dosing from Week 91-Week 104, and 4) no reactions at the Week 104 DBPCFC] will be assigned to avoid peanut (i.e. will consume 600 mg oat flour daily) and will proceed to tolerance and desensitization phase.
Drug: Peanut Protein 4,000mg
Arm A will be defined as "clinically tolerant" if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria (Appendix 4). Individuals in Arm A who meet the definition of "clinically tolerant" will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity.
Other Name: Peanut Flour

Drug: Oat Flour
Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).

Active Comparator: Peanut Protein 300 mg
Arm B on peanut OIT until week 104 and once meeting criteria specified in description of Arm A, will be assigned to be maintained on 300 mg peanut protein (i.e. 600 mg peanut flour) daily and will proceed to the tolerance and desensitization testing phase.
Drug: Oat Flour
Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).

Drug: Peanut Protein 300 mg
Arm B will be defined as "desensitized" to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study).
Other Name: Peanut Flour




Primary Outcome Measures :
  1. Passing the Week 117 DBPCFC to Peanut [ Time Frame: Week 117 - Number of participants with no clinical reactivity to peanuts ]
    Number of Participants with No Clinical Reactivity to Peanuts


Secondary Outcome Measures :
  1. Passing the DBPCFC to Peanut at Week 130 [ Time Frame: Week 130 ]
    Secondary endpoint: Passing the DBPCFC to peanut at 130 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject and/or parent guardian must be able to understand and provide informed consent and/or assent as applicable.
  • Peanut-allergic subjects between the ages of 7-55 years old.
  • Sensitivity to peanut allergen as documented by a positive skin prick test result (5 mm or greater diameter wheal relative to negative control) within 10 months preceding enrollment.
  • Allergy to peanut based on a double-blind placebo-controlled oral food challenge (DBPCFC) (see Appendix 4 for scoring details) failed at a dose ≤500 mg with peanut protein within 10 months preceding enrollment.
  • All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
  • Subjects must plan to remain in the study area during the trial.
  • Subjects must be trained on the proper use of the EpiPen (see Appendix 6) to be allowed to enroll in the study.
  • Subjects with other food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study.
  • Use of birth control by female subjects of child-bearing potential

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • History of cardiovascular disease
  • History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis) requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the Principal Investigator, would represent a risk to the subject's health or safety in this study or the subject's ability to comply with the study protocol
  • History of eosinophilic gastrointestinal disease
  • Current participation in any other interventional study
  • Subject is on 'build-up phase" of immunotherapy to another allergen (i.e., has not reached maintenance dosing)
  • Severe asthma (2007 NHLBI Criteria Steps 5 or 6) at time of enrollment
  • • Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal remedies) for atopic and/or non-atopic disease within 90 days preceding Initial Dose Escalation Day (IDED) or at any time after the IDED
  • Inability to discontinue antihistamines for the initial day of escalation, skin testing or OFCs
  • Use of omalizumab within the past six months, or current use of other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids)
  • Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  • Pregnancy or lactation
  • History of sensitivity to oat
  • History of severe anaphylaxis to peanut with symptoms including hypotension requiring fluid resuscitation and/or the need for mechanical ventilation
  • Use of investigational drugs within 24 weeks of participation
  • Past or current medical problems or findings from physical assessment or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103270


Locations
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United States, California
Sean N. Parker Center for Allergy Research at Stanford University
Mountain View, California, United States, 94040
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Kari C Nadeau, MD PhD Stanford University
  Study Documents (Full-Text)

Documents provided by Kari Christine Nadeau, MD PhD, Stanford University:
Study Protocol  [PDF] January 24, 2018
Informed Consent Form  [PDF] January 9, 2019
Statistical Analysis Plan  [PDF] January 1, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kari Christine Nadeau, MD PhD, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02103270    
Other Study ID Numbers: AADCRC-STAN-001
First Posted: April 3, 2014    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate