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Trial record 5 of 10 for:    AADCRC

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University
ClinicalTrials.gov Identifier:
NCT02103270
First received: March 25, 2014
Last updated: June 30, 2016
Last verified: June 2016
  Purpose

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 Intervention Phase
Peanut Allergy
Drug: Peanut Protein 4,000mg
Drug: Oat Flour
Drug: Peanut Protein 300 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Single Center, Placebo Controlled Clinical Study in Desensitization vs Tolerance Induction in Peanut Allergy Subjects

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Number or participants who pass a DBPCFC after the 3 month avoidance period [ Time Frame: week 117 ] [ Designated as safety issue: Yes ]
    A DBPCFC is considered a pass if there is no clinical reactivity.


Secondary Outcome Measures:
  • Predictability of immune monitoring measurements [ Time Frame: 1 to 5 years ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 120
Study Start Date: March 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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).
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
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).
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
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: 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).
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 55 Years   (Child, Adult)
Genders Eligible for Study:   Both
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 8-55 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02103270

Locations
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
Principal Investigator: Kari c Nadeau, MD PhD Stanford University
  More Information

Responsible Party: Kari Christine Nadeau, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02103270     History of Changes
Other Study ID Numbers: AADCRC-STAN-001 
Study First Received: March 25, 2014
Last Updated: June 30, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on December 09, 2016