Food Allergen OIT for Shrimp and Cashew

NCT03504774 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB-483301U01AI140498-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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 7 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).

Conditions

Allergy to Cashew Nut (Disorder); Allergy;Food; Allergy to Shrimp

Keywords

OIT; Oral Immunotherapy; Cashew Allergy; Shrimp Allergy

Outcome Measures

Primary Outcomes (1)

• Expression of CD28 in the CD4+ Allergen Specific (CD154+)

  Expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks, reported as the percentage of allergen specific (reactive) cells.

  baseline and 52 week

Secondary Outcomes (3)

• Expression of CD28+ Allergen Specific (CD154+) T-cells

  baseline, week 52 and week 58

• Expression of the Mechanistic Markers Vis Luminex Assay

  baseline, week 52, and week 58

• Expression of the Mechanistic Marker Via Flow Cytometry

  baseline, week 52, and week 58

Study Arms (1)

Cashew or Shrimp Oral Immunotherapy

EXPERIMENTAL

Participants, ages 7 to 55 years, inclusive, with an allergy to Cashew or Shrimp.

Drug: Cashew or Shrimp Oral Immunotherapy

Interventions

Cashew or Shrimp Oral Immunotherapy DRUG

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.

Also known as: OIT

Cashew or Shrimp Oral Immunotherapy

Eligibility Criteria

• Age: 7 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject and/or parent guardian must be able to understand and provide informed consent
• Age 7 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 \[determined by UniCAPTM within the past 12 months\] and/or a SPT to cashew or shrimp ≥3 mm compared to control
• 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 child-bearing potential.

You may not qualify if:

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• History of uncontrolled cardiovascular disease, including uncontrolled hypertension
• 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.
• History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD) grade 3 according to CTCAE version 5.0, symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
• Current participation in any other interventional study
• Subject is currently in the build-up phase of immunotherapy to another allergen and is on maintenance immunotherapy dose for any allergen related to cashew or shrimp
• Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6)
• Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if not controlled as indicated by an ACT\<19
• A hospitalization for asthma in the past 6 months
• ER visit for asthma within the past 6 months
• Burst or steroid course for asthma in the past 6 months
• Use of omalizumab or biologic therapy (e.g., infliximab, rituximab, etc.) within the past 6 months
• 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
• Use of beta-blockers (oral)
• Pregnancy or lactation

Sponsors & Collaborators

• Sayantani B. Sindher: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Sean N Parker Center For Allergy and Asthma Research

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• Sindher SB, Fernandes A, Manohar M, Cao S, Gupta S, Parsons E, Bogetic D, Kumar D, Rogers J, Thompson J, Dunham D, Do E, Maysel-Auslender S, Liu TA, Martinez K, Anderson B, Kaushik A, Desai M, Maecker H, Perry S, Wheatley LM, Nadeau KC, Chinthrajah RS. Trends in allergen-reactive CRTH2+ T cells and TARC associated with successful outcomes in a phase 2 cashew oral immunotherapy study. Front Immunol. 2025 Oct 22;16:1655975. doi: 10.3389/fimmu.2025.1655975. eCollection 2025.

  PMID: 41200192 RESULT

• Jiang SY, Cao S, Martinez K, Sharma R, Raeber O, Fernandes A, Bogetic D, Kaushik A, Gupta S, Manohar M, Maeker HT, Chin AR, Long AJ, Feight C, Woch M, Nadeau KC, Chinthrajah RS, Sindher SB. Shrimp oral immunotherapy outcomes in the phase 2 clinical trial: MOTIF. Front Allergy. 2025 Jul 22;6:1458131. doi: 10.3389/falgy.2025.1458131. eCollection 2025.

  PMID: 40766832 RESULT

Related Links

• Sean N. Parker Center for Allergy and Asthma Research

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Due to the COVID-19 pandemic, this study did not enroll the planned number of participants and did not meet the protocol-specified threshold for statistical significance.

Results Point of Contact

• Title: Sayantani B. Sindher, MD
• Organization: Stanford University School of Medicine

tina.sindher@stanford.edu

650-521-7237

Study Officials

• Sayantani Sindher, MD

  Stanford University, SNP Center for Food Allergy and Asthma Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Model Details: Food allergy OIT in a single group design

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 20, 2018
• Study Start: July 9, 2019
• Primary Completion: January 13, 2023
• Study Completion: March 3, 2023
• Last Updated: April 27, 2026
• Results First Posted: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)