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Food Allergen OIT for Shrimp and Cashew (MOTIF)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504774
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Kari Christine Nadeau, MD PhD, Stanford University

Brief Summary:
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 12 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).

Condition or disease Intervention/treatment Phase
Allergy;Food Allergy to Shrimp Allergy to Cashew Nut (Disorder) Drug: Cashew or Shrimp Oral Immunotherapy Phase 2

Detailed Description:

A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 12 to 55 years with an allergy to either cashew or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT). Enrolled participants must be positive at or before the 300 mg (443 mg cumulative) dosing level of FA protein. OIT treatment groups will be cashew (n=36), or shrimp (n=36).

All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. Participants that pass their food challenge with no or mild objective reactions to up to a cumulative 2043 mg of the FA allergen in their OIT at the end of this phase (primary outcome) will be considered desensitized and have successfully met the primary endpoint.

Participants then will continue in the study by undergoing withdrawal from OIT for 6 weeks to examine mechanisms underlying sustained responsiveness (SU) which will be defined as a participant's passing a DBPCFC with no or mild objective reaction to up to a cumulative 2043 mg of the FA allergen in their OIT at week 58. Participants will be followed for an additional 12 weeks to reach the end of the study phase (Week 70). There will be an opportunity to continue withdrawal with DBPCFC every 6 weeks until week 70 to be able to study the ability to maintain SU over a relatively longer term.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Food allergy OIT in a single group design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: T Cell Reagent Research for Monitoring T Cells in Food Allergy (MOTIF) Phase 2 Study Using Food Allergen Oral Immunotherapy for Shrimp or Cashew Allergies
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Cashew or Shrimp Oral Immunotherapy
Participants, ages 12 to 55 years, inclusive, with an allergy to Cashew or Shrimp.
Drug: Cashew or Shrimp Oral Immunotherapy
All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC.
Other Name: OIT




Primary Outcome Measures :
  1. Change in expression of CD28 in the CD4+ allergen specific (CD154+) [ Time Frame: 1 year ]
    Change in expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at 52 weeks relative to baseline values between those who do and do not pass the DBPCFC at week 52.


Secondary Outcome Measures :
  1. Compare changes in expression of CD28+ allergen specific (CD154+) [ Time Frame: 1 year ]
    Compare changes in expression of CD28+ allergen specific (CD154+) T-cells over multiple time points from baseline to week 58 between those with sustained unresponsiveness (SU) vs those desensitized but SU failures vs those who did not pass DBPCFC.

  2. Compare changes in the following measures in CD4+CD28+ allergen specific (CD154+) [ Time Frame: 1 year ]
    Compare changes in the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at week 52 and over multiple time points through week 58 between those who achieved sustained unresponsiveness (SU) vs those desensitized but SU failures vs those who did not pass the week 52 DBPCFC



Information from the National Library of Medicine

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Ages Eligible for Study:   12 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

  • Age 12 through 55 years (inclusive)
  • Clinical history of allergy to cashew or shrimp-containing foods
  • Serum IgE to cashew or shrimp of ≥0.35 kUA/L
  • Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines
  • Written informed consent from adult participants
  • Written informed consent from parent/guardian for minor participants
  • Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements)
  • 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.
  • Use of effective birth control by female participants of childbearing potential

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): NCT03504774


Contacts
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Contact: Kari C Nadeau, MD PhD 650-521-7237 snpcenterallergy_inquiry@stanford.edu

Locations
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United States, California
Sean N Parker Center For Allergy and Asthma Research Recruiting
Mountain View, California, United States, 94040
Contact: Kari Nadeau, MD, PhD       snpcenterallergy_scheduler@stanford.edu   
Contact: Andres Alvarez Pinzon, MD, PhD, MHA       snpcenterallergy.inquiry@stanford.edu   
Sponsors and Collaborators
Kari Christine Nadeau, MD PhD
Investigators
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Study Director: Kari C Nadeau, MD, PhD Stanford University, SNP Center for Food Allergy and Asthma Research
  Study Documents (Full-Text)

Documents provided by Kari Christine Nadeau, MD PhD, Stanford University:
Informed Consent Form  [PDF] June 12, 2019


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Responsible Party: Kari Christine Nadeau, MD PhD, Sponsor Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03504774    
Other Study ID Numbers: IRB-48330
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kari Christine Nadeau, MD PhD, Stanford University:
OIT
Oral Immunotherapy
Cashew Allergy
Shrimp Allergy
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs