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 : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allergy;Food Allergy to Shrimp Allergy to Cashew Nut (Disorder)||Drug: Cashew or Shrimp Oral Immunotherapy||Phase 2|
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.
|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)|
|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|
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
- 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.
- 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.
- 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
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
|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|