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
BUL-8 Study
The purpose of this study is to compare 1 x 2 mg/day vs 2 x 1 mg/day budenoside orodispersible tablets for the induction of histological remission in adult patients with active EoE. There are two study aims: the first group will receive one placebo and one 2mg tablet of budenoside a day, and the second group will receive one 1 mg tablet of budenoside twice a day. There is a 1-4 weeks-long screening phase in which you will undergo an upper endoscopy, unless you've had one within 12 weeks prior to the first dose, a 6-week treatment period with an endoscopy at the end, and a 4-week follow-up period. Throughout the study, you will be filling out a diary, in which you will rate the severity of your symptoms and keep track of the medication you take at home.
Eligibility Criteria
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
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
To inquire about these trials, email BFAC Research for more information.
Eosinophilic Gastrointestinal Diseases (EGIDs)
EGID Blood Draw
The study seeks to collect blood samples from patients with active eosinophilic gastrointestinal diseases (EGIDs), such as EoE, to investigate biomarkers and assess whether vedolizumab could be a potential treatment for EGIDs. Participation involves a single visit, during which the research team will review the consent form, discuss your medical history, EGID symptoms, and diagnosis, and collect 6 tubes of blood (~30mL, about a tenth of a typical blood donation). Participants will receive $250, and the results of viral screenings (for HIV and HCV), which is one of the blood samples collected, will be shared with you at no cost.
Eligibility Criteria
To inquire about this trial, email BFAC Research for more information.
Celiac Disease
What is celiac disease?
Celiac disease is a chronic digestive and immune disorder that damages the lining of the small intestine, preventing nutrient absorption. This is an autoimmune disorder in which the body releases antibodies that attack the small intestine when the individual consumes gluten. Symptoms of celiac disease include weight loss, diarrhea, anemia, neurological symptoms, etc. The only treatment that is currently available for celiac disease is strict adherence to a gluten free diet.
DRI 17963 Clinical Trial for Celiac Disease
Eligible participants will be randomly assigned to receive either 250mg Amlitelimab (study drug, administered as subcutaneous injection), 500mg Amlitelimab, or placebo (no active drug), in combination with one of two supplements. The supplement will be a tablet taken orally, and will either contain a very small amount of gluten (equivalent to half a bite of bread, meant to simulate inadvertent gluten exposure), or will not contain any active ingredient (placebo); note that the supplement is only given between weeks 12-24. Treatment will last 24 weeks total, and there will be an upper endoscopic procedure at the beginning and end of the treatment period. Eligible participants may opt into a 140-week long term extension period of the study, where Amlitelimab will be given at either a 250 or 500mg dose (no supplements taken during this phase). Visits, including endoscopy procedures, are paid for by the study sponsor, Sanofi, and participants are compensated $125 per visit and $500 per endoscopy procedure.
Eligibility Criteria
To inquire about this trial, email BFAC Research for more information.
Hypereosinophilic Syndrome
What is Hypereosinophilic Syndrome?
Hypereosinophilic syndrome (HES) is the presence of excess eosinophils in the bloodstream. Eosinophils normally circulate throughout the body in small amounts, but an excess can cause a variety of symptoms such as fatigue, cough, muscle pain, fever, rash, etc. Current treatment options include oral corticosteroids or biologic medications.
GSK Destiny Study for Hypereosinophilic Syndrome
This study is a phase 3 randomized, double-blinded, placebo-controlled trial to assess the efficacy and safety of Depemokimab in treating adults with hypereosinophilic syndrome (HES). If you are eligible for randomization, then you will receive the study drug or placebo (2:1 chance of receiving study drug) for a 52 week period. A 4 week follow-up period will follow the study period. Depemokimab will be administered via subcutaneous injection once every 6 months.
Eligibility Criteria
18 years or older
Diagnosis of HES (via labwork)
2 HES flares within the last 12 months
Cannot have failed an anti IL-5 medication in the past
Learn more here
To inquire about this trial, email BFAC Research for more information.
Hypereosinophilic syndrome (HES) is the presence of excess eosinophils in the bloodstream. Eosinophils normally circulate throughout the body in small amounts, but an excess can cause a variety of symptoms such as fatigue, cough, muscle pain, fever, rash, etc. Current treatment options include oral corticosteroids or biologic medications.
GSK Destiny Study for Hypereosinophilic Syndrome
This study is a phase 3 randomized, double-blinded, placebo-controlled trial to assess the efficacy and safety of Depemokimab in treating adults with hypereosinophilic syndrome (HES). If you are eligible for randomization, then you will receive the study drug or placebo (2:1 chance of receiving study drug) for a 52 week period. A 4 week follow-up period will follow the study period. Depemokimab will be administered via subcutaneous injection once every 6 months.
Eligibility Criteria
Learn more here
To inquire about this trial, email BFAC Research for more information.
Atopic Dermatitis
What is Atopic Dermatitis?
Atopic dermatitis, also known as eczema, is a chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. This condition can be triggered by several factors including allergies, certain clothing materials, chemical products, exposure to heat and cold, etc. Common treatments include topical corticosteroids, non-steroidal topicals, and biologics.
Abbvie Clinical Trial for Atopic Dermatitis
This is a phase 3b/4 open label, randomized control trial to evaluate the efficacy and safety of Upadacitinib in the treatment of adults with moderate to severe atopic dermatitis that has been refractory to dupilumab. In the first part of this study, participants will have a 1:1 chance of receiving Dupixent or Rinvoq for an 8 week period. After this period, subjects will then be randomized again to 24 weeks of treatment with either Rinvoq or Dupixent based on their symptomatic response in the first part of the study.
Eligibility Criteria
Learn more here
To inquire about this trial, email BFAC Research for more information.
Chronic Spontaneous Urticaria
What is CSU?
Chronic spontaneous urticaria (CSU) is defined by the presence of hives (red, raised wheals) that occur intermittently for more than 6 weeks without any clear triggers. This condition canresult in angioedema and pruritus. The first line of treatment for CSU is antihistamines, and if these are ineffective then patients may consider other options such as Xolair.
We will soon have a trial available for patients with a history of CSU for at least 3 months, who are experiencing symptoms despite taking a daily dose of first generation antihistamines. Please reach out to research@bfac.org if you're interested.
Chronic spontaneous urticaria (CSU) is defined by the presence of hives (red, raised wheals) that occur intermittently for more than 6 weeks without any clear triggers. This condition canresult in angioedema and pruritus. The first line of treatment for CSU is antihistamines, and if these are ineffective then patients may consider other options such as Xolair.
We will soon have a trial available for patients with a history of CSU for at least 3 months, who are experiencing symptoms despite taking a daily dose of first generation antihistamines. Please reach out to research@bfac.org if you're interested.
