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
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
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
Learn more here
To inquire about these trials, email BFAC Research for more information.
Eosinophilic gastritis
What is Eosinophilic Gastritis?
Eosinophilic Gastritis (EoG), is a rare disease in which excess eosinophils in the stomach cause irritation. This disease typically presents with symptoms of abdominal pain, nausea/vomiting, and difficulties eating. This disease can only be diagnosed via biopsies taken during an upper endoscopy, and current treatment options include proton pump inhibitors, oral steroids, and food elimination diets.
Eosinophilic Gastritis Regeneron Clinical Trial
This is a phase ⅔ randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Dupilumab, a subcutaneous injection, in patients with eosinophilic gastritis with or without eosinophilic gastritis. If you are eligible for randomization, you will receive either the study drug or placebo (1:1 chance of receiving study drug) for a period of 24 weeks, which will be followed by an open-label period in which you will receive the study drug for 28 weeks. This drug is administered on a weekly basis, and you will come into our clinic for visits every 4 weeks.
Eligibility Criteria
Learn more here
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.
Ulcerative Colitis
What is Ulcerative Colitis?
Ulcerative colitis (UC) is an inflammatory bowel disease that causes inflammation and ulcers in the innermost lining of the colon. This inflammation can result in symptoms of diarrhea, rectal bleeding, and abdominal pain. Current treatment options for UC include corticosteroids, JAK inhibitors, biologic medications, and other anti-inflammatory medications.
Celgene Ulcerative Colitis Clinical Trial
This is a phase 4 open-label study to further assess the efficacy and safety of Ozanimod in the treatment of adults with moderate to severe ulcerative colitis. If randomized, you will take the medication (oral tablet) daily for a one year period, and you will be expected to attend approximately 6 clinic visits during this time. The follow-up period for this study is 52 weeks in which you will continue to receive the study drug and follow-up with the clinic regarding your response.
Eligibility Criteria
18 years or older
Must have moderate to severe UC as diagnosed via Mayo scoring
Cannot have used JAK inhibitors in the past
Learn more here
To inquire about this trial, email BFAC Research for more information.
Ulcerative colitis (UC) is an inflammatory bowel disease that causes inflammation and ulcers in the innermost lining of the colon. This inflammation can result in symptoms of diarrhea, rectal bleeding, and abdominal pain. Current treatment options for UC include corticosteroids, JAK inhibitors, biologic medications, and other anti-inflammatory medications.
Celgene Ulcerative Colitis Clinical Trial
This is a phase 4 open-label study to further assess the efficacy and safety of Ozanimod in the treatment of adults with moderate to severe ulcerative colitis. If randomized, you will take the medication (oral tablet) daily for a one year period, and you will be expected to attend approximately 6 clinic visits during this time. The follow-up period for this study is 52 weeks in which you will continue to receive the study drug and follow-up with the clinic regarding your response.
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.
Allakos Clinical Trial for Chronic Spontaneous Urticaria
This trial is a phase I, double-blind, randomized, placebo controlled trial for assess the efficacy of AK006 in patients with chronic spontaneous urticaria. In this study, participants will have a 2:1 chance of receiving the active treatment, which will be administered via 4 IV infusions every 4 weeks. The patients will also complete daily diaries to evaluate symptoms, and they will be followed for 12 weeks to monitor safety and clinical response to the medication.
Eligibility Criteria
Age range of 18-65 years
Must have CSU diagnosis for at least 6 months
CSU must be refractory to antihistamines
Learn more here
To inquire about this trial, email BFAC Research for more information.
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.
Allakos Clinical Trial for Chronic Spontaneous Urticaria
This trial is a phase I, double-blind, randomized, placebo controlled trial for assess the efficacy of AK006 in patients with chronic spontaneous urticaria. In this study, participants will have a 2:1 chance of receiving the active treatment, which will be administered via 4 IV infusions every 4 weeks. The patients will also complete daily diaries to evaluate symptoms, and they will be followed for 12 weeks to monitor safety and clinical response to the medication.
Eligibility Criteria
Learn more here
To inquire about this trial, email BFAC Research for more information.
Upcoming Clinical Trials
Allakos Clinical Trial for Chronic Spontaneous Urticaria
This trial is a phase I, double-blind, randomized, placebo controlled trial for assess the efficacy of AK006 in patients with chronic spontaneous urticaria. In this study, participants will have a 2:1 chance of receiving the active treatment, which will be administered via 4 IV infusions every 4 weeks. The patients will also complete daily diaries to evaluate symptoms, and they will be followed for 12 weeks to monitor safety and clinical response to the medication. This study is projected to open for enrollment in spring of 2024. To inquire about this clinical trial, email BFAC Research
