Boston Specialists
Clinical Trials
Research at Boston Specialists focuses on understanding the various facets of eosinophilic gastrointestinal disorders (EGIDs), other GI conditions such as inflammatory bowel syndrome, and allergic conditions such as chronic spontaneous urticaria. In our recent work, we have explored the molecular and clinical characteristics of GI and allergy conditions, investigated the use of innovative biologic therapies for the diseases, and piloted initiatives to combat barriers of treatment for patients with these conditions. 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 inflammatory bowel syndrome, mast cell GI disease, and celiac disease.
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.
Current 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
Vonoprazan for EoE
Enrollment for this trial is closed. We are no longer accepting new participants.
This study compares vonoprazan (Voquezna) 20 mg daily versus placebo over a 12-week placebo-controlled treatment period, followed by an optional 12-week long-term extension during which all participants receive vonoprazan 20 mg daily. Participants will complete daily electronic diary entries.
Eligible participants must be symptomatic with dysphagia and on a stable diet for at least six weeks, either following a food elimination diet (FED) or no FED. Key exclusions include PPI-refractory disease, other eosinophilic gastrointestinal or inflammatory GI diseases, other eosinophilic conditions, use of PPIs or swallowed topical corticosteroids within the past two months, and use of dupilumab within the past three months.
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
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
This clinical trial is currently paused and is not actively enrolling participants. We will update this page with any new information if enrollment resumes in the future.
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
Irritable bowel syndrome (IBS-D/IBS-M)
What is IBS-D/IBS-M?
Irritable bowel syndrome (IBS) is a chronic disorder of gut-brain interaction characterized by recurrent abdominal pain associated with changes in bowel appearance and frequency. IBS-D (diarrhea-predominant IBS) typically presents with frequent loose stools, urgency, and increased stool frequency, whereas IBS-M (mixed-type IBS) is characterized by alternating episodes of diarrhea and constipation. The diagnosis of IBS is based on clinical criteria, including the Rome IV criteria, after appropriate evaluation to exclude other gastrointestinal disorders such as inflammatory bowel disease, celiac disease, and colorectal pathology. Standard treatment options include dietary modification (such as a low-FODMAP diet), fiber supplementation, antidiarrheal agents, antispasmodics, and other prescription therapies targeted to patients’ symptoms.
IBS-D/IBS-M Clinical Trials at Boston Specialists
GSK Clinical Trial for IBS-D/IBS-M
This study aims to study the efficacy of Camlipixant, an oral neuromodulator, in treating abdominal pain in IBS-D and IBS-M patients over 26-week course. The goal is to compare 25mg, 50mg, 100mg of Camlipixant twice daily in affecting the Abdominal Pain Index in patients. Participants will randomized into one treatment dose or placebo for the first 12 weeks and re-randomized again for the second half of the study. Throughout the study, participants will visit our clinic at regular intervals for safety assessment and physical examinations.
Eligibility criteria:
1) Male or female age 18-80
2) Confirmed IBS-D/IBS-M diagnosis per Rome IV criteria
3) Currently experiencing IBS-D/IBS-M symptoms such as abdominal pain and changes in stool habit
Irritable bowel syndrome (IBS) is a chronic disorder of gut-brain interaction characterized by recurrent abdominal pain associated with changes in bowel appearance and frequency. IBS-D (diarrhea-predominant IBS) typically presents with frequent loose stools, urgency, and increased stool frequency, whereas IBS-M (mixed-type IBS) is characterized by alternating episodes of diarrhea and constipation. The diagnosis of IBS is based on clinical criteria, including the Rome IV criteria, after appropriate evaluation to exclude other gastrointestinal disorders such as inflammatory bowel disease, celiac disease, and colorectal pathology. Standard treatment options include dietary modification (such as a low-FODMAP diet), fiber supplementation, antidiarrheal agents, antispasmodics, and other prescription therapies targeted to patients’ symptoms.
IBS-D/IBS-M Clinical Trials at Boston Specialists
GSK Clinical Trial for IBS-D/IBS-M
This study aims to study the efficacy of Camlipixant, an oral neuromodulator, in treating abdominal pain in IBS-D and IBS-M patients over 26-week course. The goal is to compare 25mg, 50mg, 100mg of Camlipixant twice daily in affecting the Abdominal Pain Index in patients. Participants will randomized into one treatment dose or placebo for the first 12 weeks and re-randomized again for the second half of the study. Throughout the study, participants will visit our clinic at regular intervals for safety assessment and physical examinations.
Eligibility criteria:
1) Male or female age 18-80
2) Confirmed IBS-D/IBS-M diagnosis per Rome IV criteria
3) Currently experiencing IBS-D/IBS-M symptoms such as abdominal pain and changes in stool habit
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.
We do not currently have celiac disease trials open for enrollment, but we will update our website as soon as we do.
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.
CSU Clinical Trials at Boston Specialists
CLOU064AUS02 Clinical Trial for CSU
Eligible participants will be randomly assigned to receive 25mg remibrutinib (tablet taken by mouth) twice a day or dupilumab subcutaneous injections (600mg loading dose, with 300mg every 2 weeks after); treatment will last 12 weeks, with a 12-week optional open-label extension where patients will receive 25mg remibrutinib twice a day. Visits are paid for by the sponsor, Novartis, and participants are compensated $180 per completed visit.
Eligibility criteria:
1) Male or female age >18
2) Confirmed CSU diagnosis for >6 months in addition to inadequate response to H1 antihistamines (Zyrtec, Allegra, Claritin, etc) for >6 consecutive weeks
3) Documentation of hives within 3 months of enrollment
4) Urticaria activity score (assessed via patient eDiary) >16.
Additional criteria will be assessed by the study doctor.
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.
CSU Clinical Trials at Boston Specialists
CLOU064AUS02 Clinical Trial for CSU
Eligible participants will be randomly assigned to receive 25mg remibrutinib (tablet taken by mouth) twice a day or dupilumab subcutaneous injections (600mg loading dose, with 300mg every 2 weeks after); treatment will last 12 weeks, with a 12-week optional open-label extension where patients will receive 25mg remibrutinib twice a day. Visits are paid for by the sponsor, Novartis, and participants are compensated $180 per completed visit.
Eligibility criteria:
1) Male or female age >18
2) Confirmed CSU diagnosis for >6 months in addition to inadequate response to H1 antihistamines (Zyrtec, Allegra, Claritin, etc) for >6 consecutive weeks
3) Documentation of hives within 3 months of enrollment
4) Urticaria activity score (assessed via patient eDiary) >16.
Additional criteria will be assessed by the study doctor.
Mastocytosis
Bezuclastinib Expanded Access Program for Patients with Non-advanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
This expanded access program (EAP) is designed to provide investigational bezuclastinib to patients with systemic mastocytosis who have no comparable or satisfactory alternative treatment options. Bezuclastinib is administered at a dose of 100 mg once daily for NonAdvSM and 150 mg once daily for AdvSM.
Eligible patients include those with non-advanced forms such as indolent systemic mastocytosis (ISM), bone marrow mastocytosis, and smoldering systemic mastocytosis (SSM), as well as advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL).
This expanded access program (EAP) is designed to provide investigational bezuclastinib to patients with systemic mastocytosis who have no comparable or satisfactory alternative treatment options. Bezuclastinib is administered at a dose of 100 mg once daily for NonAdvSM and 150 mg once daily for AdvSM.
Eligible patients include those with non-advanced forms such as indolent systemic mastocytosis (ISM), bone marrow mastocytosis, and smoldering systemic mastocytosis (SSM), as well as advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL).
