# Mount Sinai's COFAR Clinical Research Unit and Clinical Trial (The "ADVANCE" Trial).

> **NIH NIH UM1** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2020 · $235,000

## Abstract

Project Summary/Abstract
MOUNT SINAI’S CoFAR CLINICAL RESEARCH UNIT AND CLINICAL TRIAL (THE “ADVANCE” TRIAL)
Food allergy affects up to 8% of children and approximately 5% of adults, is a significant burden on quality of
life, is costly, and can be fatal. Significant advances have been made in identifying potential treatment and
prevention strategies. Oral (OIT), sublingual (SLIT), and epicutaneous (EPIT) immunotherapy, as well as
combination therapy using OIT and omalizumab, and simply having children who are reactive to egg or milk
ingest extensively heated forms if they can, have all shown promise to improve treatment. However, limitations
of these approaches, including variable efficacy, side effects, costs, and lack of sustained unresponsiveness
off treatment frame the need for better therapies. Exciting advances in prevention, specifically the efficacy of
early introduction of peanut, have been recently noted. However, more needs to be done to identify the most
effective prevention strategies. The objectives of the Consortium for Food Allergy Research (CoFAR) are to
conduct ground-breaking trials and studies in treatment and prevention of food allergy, and to incorporate
mechanistic studies. The long-term goals of CoFAR are to develop effective strategies to prevent and treat
food allergies, and to elucidate underlying immunologic mechanisms. The major objective of the Mount Sinai
CoFAR Clinical Research Unit (CRU) is to provide CoFAR with outstanding study opportunities and to propose
a clinical trial to achieve the above stated goals. The Mount Sinai CRU team has been successfully and safely
conducting food allergy research since 1997. It has contributed to every interventional study described above,
and has an extensive portfolio of additional clinical studies. The CRU PI, Scott Sicherer, MD, brings broad
experience having been site PI for all of the past CoFAR interventional trials, as well as being Protocol Chair of
the CoFAR observational clinical study. He also brings extensive experience from a myriad of areas of food
allergy research, including additional treatment trials, registries, diagnostics, and performing quality of life and
epidemiologic research and has been a mentor to numerous food allergy investigators. Co-Investigators Drs.
Wang and Bunyavanich have served as successful PIs on clinical trials. Two early stage investigators are on
the team and will benefit from their involvement to become the next generation of leaders in food allergy
research. The Mount Sinai laboratory facilities have been the biomarker core for CoFAR and other multicenter
studies and can easily manage biological samples at the direction of the Leadership Center (LC). The Mount
Sinai CRU is located in Manhattan, with access to an extensive base of potential participants; it has safely
conducted >20,000 oral food challenges and has a superb record of study recruitment and retention. To
increase opportunities to contribute to CoFAR’s goals, a clinical t...

## Key facts

- **NIH application ID:** 9873913
- **Project number:** 5UM1AI130570-04
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** SCOTT H SICHERER
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $235,000
- **Award type:** 5
- **Project period:** 2017-03-05 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9873913

## Citation

> US National Institutes of Health, RePORTER application 9873913, Mount Sinai's COFAR Clinical Research Unit and Clinical Trial (The "ADVANCE" Trial). (5UM1AI130570-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9873913. Licensed CC0.

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