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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Food allergy OIT in a parallel group design|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504774
|Contact: Kari C Nadeau, MD PhDfirstname.lastname@example.org|
|United States, California|
|Sean N Parker Center For Allergy and Asthma Research||Recruiting|
|Mountain View, California, United States, 94040|
|Contact: Kari Nadeau, MD, PhD email@example.com|
|Contact: Andres Alvarez Pinzon, MD, PhD, MHA firstname.lastname@example.org|
|Study Director:||Kari C Nadeau, MD PhD||Stanford University, SNP Center for Food Allergy and Asthma Research|