Boston Specialists

Clinical Trials

Research at Boston Specialists focuses on understanding the various facets of eosinophilic gastrointestinal disorders (EGIDs), as well as other GI and allergic conditions. In our recent work, we have explored the molecular and clinical characteristics of EGIDs, investigated the use of innovative biologic therapies and novel strategies to treat EGIDs, and piloted initiatives to combat barriers of treatment for EGID patients. Our long term goal is to improve the lives of our patients by deepening our understanding and expanding our management options of disease through the use of evidence-based research. Additionally, we have recently expanded our scope of interest to include other chronic inflammatory conditions of the GI tract including mast cell GI disease, celiac disease, etc.

As the first multispecialty non-academic private practice performing clinical trials in Boston, we are focused on executing these trials both efficiently and effectively. We are an approved IRB research site, and we are at the leading edge of change and development in the allergy and GI fields. Clinical trials at academic institutions can have long set up times (from contract negotiation to screening) and can be prohibitively expensive and bureaucratic.

Our Mission

At Boston Specialists, we aim to reduce the time it takes to set up and start trials using professional central IRB agencies, experienced contract and budget negotiators, and responsive support staff. Our mission is to use our small, specialized team of researchers to conduct clinical trials and research to expand the boundaries of medicine, while being as transparent and respectful of patients as possible. We aim to use cutting-edge therapies to treat patients who have failed to respond to conventional treatments for both rare and common diseases.

Benefits of Enrolling in a Clinical Trial

Enrolling in a clinical trial may benefit you by giving you access to potentially more effective treatment options before they become available to the public. You will also be receiving medical attention, medication administration, medical testing, and procedures free of charge. Additionally, the clinical trial sponsors will compensate you for your participation in the clinical trial.

Currently Enrolling Clinical Trials

Eosinophilic esophagitis (EoE)

What is eosinophilic esophagitis?
Eosinophilic esophagitis (EoE) is an inflammation of the esophagus, which connects the mouth to the stomach. This inflammation is specifically caused by an excess of eosinophils. EoE typically presents with symptoms of dysphagia, epigastric pain, food impactions, acid reflux, and nausea/vomiting, but EoE can have other atypical presentations as well. This disease can only definitively be diagnosed via biopsies collected during an upper endoscopy, and standard of care treatment options include proton pump inhibitors, food elimination diets, or swallowed steroids.

EoE Clinical Trials at Boston Specialists

Evolve Celldex Study
This is a phase 2 randomized, double-blind, placebo-controlled study to assess the efficacy and safety of a subcutaneous injection called Barzolvolimab. If you are eligible, you will be assigned either placebo or study medication for 16 weeks (1:1 chance of receiving study drug), followed by 12 weeks of active treatment (study drug guaranteed). This study will take place over the course of a year, with visits every 4 weeks, and injections will be administered every 8 weeks.

Eligibility Criteria

18 years or older

Confirmed diagnosis of EoE

Has tried and failed a standard of care EoE treatment

Has not eliminated foods from diet within 2 months

Learn more here

AstraZeneca Crossing Study
This is a phase 3 randomized, double-bind, placebo-controlled study to assess the efficacy and safety of Tezepelumab, a subcutaneous injection, for the treatment of EoE. If you are eligible for randomization, you will either receive the study drug or placebo (2:1 chance of receiving study drug) for a period of 52 weeks, and you will then receive the study drug in an open label period lasting 24 weeks. The visits will occur every 4 weeks, and study drug will be injected at each visit.

Eligibility Criteria

18 years or older

Confirmed diagnosis of EoE

Cannot have other GI disease

Stable diet 8 weeks prior to screening

Tried and failed a standard of care treatment

Learn more here

Alamere EoE Study
This is a phase 2 randomized, double-blind, placebo-controlled study to assess the efficacy and safety of a subcutaneous injection called Solrikitug in adults with eosinophilic esophagitis. If you are eligible, you will be assigned either placebo or study medication for 24 weeks (72% chance of receiving study drug), followed by 28 weeks of active treatment (study drug guaranteed). There is also a 16 week safety follow-up period after the open-label period. This study will take place over the course of ~72 weeks with visits occurring every 2-4 weeks and injections being administered every 4 weeks.

Eligibility Criteria

18-75 years of age

Confirmed diagnosis of EoE

Tried and failed a standard of care treatment

Learn more here

EoE Dupixent Registry (Regeneron)
This study aims to follow patients with EoE who are starting DUPIXENT (dupilumab) for 3 years after treatment initiation. The goal is to collect long-term outcomes and safety data on EoE patients treatment with DUPIXENT. The registry will collect your patient demographic data, medical history, and data related to prior EoE therapies. It will also collect data on the utilization of DUPIXENT during treatment, including the use of any concomitant medications. The visits are remote or in person, and will be conducted at month 3 for 1 year after starting treatment, and then every 6 months for the rest of the study.

Eligibility Criteria

12 years or older

Initiating treatment with DUPIXENT for EoE

To inquire about these trials, email BFAC Research for more information.