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Food Allergen OIT for Shrimp and Cashew (MOTIF)

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ClinicalTrials.gov Identifier: NCT03504774
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : August 6, 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 in cashew or shrimp in participants with proven allergies to cashew or shrimp food. OIT treatment groups will be cashew or shrimp.

After determining their specific food allergen, subjects will undergo a dose escalation day to reach 5 mg allergen, after which they will return to the clinic every 2 weeks to escalate their allergen dose to reach a 300 mg dose at week 21. Participants then will be maintained at that dose for 3 weeks (Maintenance Phase). Participants that pass a Double Blind-Placebo Controlled-Food Challenge (DBPCFC) at the end of their maintenance period (week 21) will be declared desensitized and will continue in the study for 6 more weeks to examine mechanisms underlying sustained unresponsiveness (SU) by a second DBPCFC at week 30. Participants then will be followed for an additional 8 weeks to reach the end of the study phase (Week 38).


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

Detailed Description:

The site will enroll 72 participants, ages 12 to 55 years with an allergy to either cashew, or shrimp determined by DBPCFC, allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT). OIT treatment groups will be cashew (n=36), or shrimp (n=36).

The subject's allergen will be introduced in a Dose Escalation Day at week 1. All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 300 mg dose at week 21, after which they will be maintained at that dose for 3 weeks. At the conclusion of the maintenance phase (Week 24), participants will undergo DBPCFC to determine desensitization. Participants that pass their food challenge with no or mild objective reactions to up to a cumulative 1044 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 unresponsiveness (SU) which will be defined as a participant's passing a DBPCFC with no or mild objective reaction to up to a cumulative 1044 mg of the FA allergen in their OIT at week 30. Participants will be followed for an additional 8 weeks to reach the end of the study phase (Week 38). There will be an opportunity to continue withdrawal every 6-8 weeks until week 52 to be able to study the ability to maintain SU over a relatively longer term. Each subject is planned to be enrolled in the active phase of the study for at least 38 weeks. There will be an opportunity to continue in the study till week 52 within clinic follow up visits every 6-8 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Food allergy OIT in a parallel group design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shrimp or Cashew Food Oral Immunotherapy
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 Oral Immunotherapy
Participants, ages 12 to 55 years, inclusive, with an allergy to Cashew.
Biological: Cashew Oral Immunotherapy
Subjects will undergo a staged dose escalation to a maintenance dose of cashew OIT, which will start at 5 mg and escalate to 300 mg maintenance over 21 weeks.
Other Name: OIT

Experimental: Shrimp Oral Immunotherapy
Participants, ages 12 to 55 years, inclusive, with an allergy to Shrimp.
Biological: Shrimp Oral Immunotherapy
Subjects will undergo a staged dose escalation to a maintenance dose of shrimp OIT, which will start at 5 mg and escalate to 300 mg maintenance over 21 weeks.
Other Name: OIT




Primary Outcome Measures :
  1. Proportion of Participants Desensitized to Food Allergen [ Time Frame: Week 24 ]
    Proportion (%) of participants in each cohort who successfully pass a Double-Blind, Placebo-Controlled, Food Challenge (DBPCFC) to a cumulative 1044 mg of the FA allergen at the end of OIT


Secondary Outcome Measures :
  1. Proportion of Participants with Sustained Unresponsiveness to Food Allergens [ Time Frame: Week 30 ]
    Proportion (%) of participants in each cohort who successfully pass a DBPCFC to a cumulative 1044 mg of the FA allergen after 6 weeks off OIT.

  2. Proportion of Participants with Long Term Sustained Unresponsiveness to Food Allergens [ Time Frame: Week 36, Week 44, Week 52 ]
    Proportion (%) of participants in each cohort who successfully pass the DBPCFC on week 30 and continue FA avoidance and pass a DBPCFC to a cumulative 1044 mg at weeks 36, 44, and 52



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:

  1. Subject and/or parent guardian must be able to understand and provide informed consent
  2. Age 12 through 55 years (inclusive)
  3. Clinical history of allergy to cashew or shellfish-containing foods
  4. Serum IgE to cashew or shellfish of ≥0.35 kUA/L [determined by UniCAP within the past 12 months] and/or a SPT to milk, cashew, or shrimp ≥3 mm compared to control
  5. Experience dose-limiting symptoms at or before the 100 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines
  6. Written informed consent from adult participants
  7. Written informed consent from parent/guardian for minor participants
  8. Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements)
  9. 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.
  10. Use of effective birth control by female participants of child-bearing potential

Exclusion Criteria:

  1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  2. History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
  3. History of other chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) requiring therapy (e.g., heart disease, diabetes) that is, or is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen and, 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.
  4. History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
  5. Current participation in any other interventional study
  6. Subject is on immunotherapy to another allergen
  7. Severe asthma (2007 NHLBI Criteria Steps 5 or 6)
  8. Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4), if controlled as measured by an ACT>19
  9. A hospitalization for asthma in the past year
  10. ER visit for asthma within the past six months
  11. Burst or steroid course for asthma in the past 3 months or >2 oral steroid courses in the past year
  12. Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy (e.g., infliximab, rituximab, etc.) within the past 6 months
  13. 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
  14. Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  15. Pregnancy or lactation
  16. Allergy to oat (placebo in DBPCFC)
  17. History of severe anaphylaxis to milk, cashew or shrimp with symptoms including hypotension requiring fluid resuscitation and/or the need for mechanical ventilation
  18. Use of investigational drugs within 24 weeks of participation
  19. 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): NCT03504774


Contacts
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Contact: Kari C Nadeau, MD PhD 650-724-0293 snpcenterallergy_scheduler@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     History of Changes
Other Study ID Numbers: IRB-48330
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 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

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs