148 Clinical Trials for Various Conditions
The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making. This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will assess the feasibility and acceptability of the intervention to inform future R01-level studies. The study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients. Additionally, that patients that use the intervention (vs general education about EoE) will report greater treatment knowledge, increased readiness to choose a therapy, adherence to therapy, and follow-up.
This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE. Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward. Patient questionnaires will measure the following: * How EoE makes one feel * EoE symptoms * How EoE affects quality-of-life * How EoE impacts aspects of daily life * How difficult it is to swallow * How EoE symptoms have changed throughout the study
The goal of this study is to research Dupilumab, an FDA approved medication in treating patients diagnosed with Eosinophilic esophagitis (EoE). The drug works by controlling allergic inflammation of the esophagus. The esophagus is a food pipe that transfers food from the mouth into the stomach. Participants with EoE have dysfunction of the muscle of the esophagus (impaired peristalsis) that is not favorable for the transport function. Main question this study aims to answer is: Whether Dupilumab helps improve muscle activity of the esophagus in participants with EOE? Participants will: Take Dupilumab every week for 12 weeks. Visit the clinic before and after starting the medication. Keep a diary of symptoms.
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of Eosinophilic Esophagitis (EoE). The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy. Investigators will compare the efficacy of the Esophageal String Test to symptom assessment using a validated patient reported symptom questionnaire, the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits.
The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab. Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses. Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed. At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test.
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) * Screening period: Up to 12 weeks before Week 0 * Randomized double-blind period: 24 weeks * Open label period: 104 weeks * Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE).
This is a 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (≥18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension. This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at bedtime) for the induction of response to treatment (symptomatic and histologic) over 24 weeks. The open-label extension will continue to evaluate long-term safety in subjects who consent to continue on open-label treatment with APT-1011.
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).
This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.
The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.
This study evaluates the decrease in steroid dosing for patients who have achieved remission on a full dose of steroids. Once a patient is in remission they will be enrolled in this study if they choose to decrease the steroid dosing.
Eosinophilic Esophagitis (EoE) is a food driven non-immunoglobulin E (IgE) mediated disease involving eosinophils and type 2 inflammation. Current therapies include diet and the off label use of medications including proton pump inhibitors, topical steroids or biologics. Food elimination creates a decrease quality of life in many children. The goal of the study is to examine a T2 inhibitor (dupilumab) can allow successful reintroduction of allergic EoE foods into the diet. This is a single site study, enrolling subjects 6 to 25 years of age.
Eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, is a clinical and financial burden to patients if left untreated. Often the natural history of the disease includes development of fibrosis and stricturing of the esophagus, acute food impactions, unplanned emergency room visits, and invasive procedures such as endoscopy. Currently there are no Food and Drug Administration (FDA) approved medications for the treatment of EoE. As such, pharmacologic options approved for use in asthma are used for treatment of EoE and include proton pump inhibitors and swallowed topical steroids. These medications are prescribed chronically as EoE is considered a lifelong disease. Chronic administration of exogenous steroids, when given in inhaled or systemic preparations, can lead to adrenal insufficiency (AI). AI is seen in 7.8% of patients receiving chronic inhaled steroids and 48.7% of patients receiving chronic systemic steroids. The administration of steroids in EoE is unique, as patients typically swallow topical preparations of the drug. The risk of secondary AI from taking swallowed topical steroids is currently unknown, as there has been no study in an adult population assessing this risk as a primary endpoint. Pediatric studies of patients with EoE have shown the risk of AI from swallowed topical steroids to be 5-10%. Based on the risk of AI with inhaled steroids (7.8% prevalence) and the prevalence of AI from swallowed topical steroids in pediatric populations (5-10%), we hypothesize that the risk with swallowed topical steroids is \>5%. This could warrant consideration of screening given the potentially serious consequences of undiagnosed AI. To address this hypothesis, this project aims to define the prevalence of developing AI in adults with EoE taking swallowed topical steroids and compare that prevalence to a similar control population of adults with EoE who are taking proton pump inhibitors.
This study is to observe the efficacy of the four food elimination diet.
Eosinophilic Esophagitis (EoE) is a chronic, immune-mediated allergic inflammatory disorder that is being diagnosed with increased frequency. Compelling evidence suggests the etiopathogenesis is allergic and the immune response is triggered by food antigens in most children afflicted with this condition. The literature characterization of EoE is descriptive and retrospective thus far. Our aim in collecting and analyzing data prospectively of all EoE patients seen at Ann \& Robert H. Lurie Children's Hospital (Lurie Children's) is to better understand the etiology, pathogenesis and clinical presentation of EoE in patients to better delineate its association with other atopic conditions including reactive airway disease, seasonal allergies and atopic dermatitis. This will allow us to better evaluate the effectiveness of therapeutic strategies used to treat patients with EoE. In addition to collecting data prospectively, the investigators will also review the charts of EoE patients and those suspected of having EoE seen at Lurie Children's. This will allow us to also gather information on control patients, not diagnosed with EoE, who may not be followed in EoE clinic.
The purpose of this study to evaluate the potential for disease-mediated drug-drug interactions between cendakimab and selected substrates of metabolic enzymes in eosinophilic esophagitis participants.
This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.
The purpose of this study is to asses the efficacy, safety and tolerability of repeat doses of IRL201104 in Adult Participants with Active Eosinophilic Esophagitis (EoE)
This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to \<18 years) with EoE.
The investigators seek to assess the efficacy of removing cow's milk from an EoE patient's diet. This will be determined by esophageal inflammation and clinical and histological response to the milk elimination treatment.
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
The purpose of this study is to evaluate the relationship between fractionated exhaled nitric oxide, peripheral eosinophils, and plasma citrulline and ß-alanine in patients with eosinophilic esophagitis (EoE) compared to those without EoE. The hypothesis is that a combination of elevated fractional exhaled nitric oxide, increased peripheral eosinophils, and elevated plasma citrulline and ß-alanine is associated with active EoE.
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: * Placebo for Induction and Maintenance * CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance * CC-93538 360 mg SC once weekly for Induction and Maintenance
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.
The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.
The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: * To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) * To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE * To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation * To study the effects of dupilumab on the type 2 inflammation gene expression signature * To evaluate the concentration-time profile of functional dupilumab in serum in this population * To assess efficacy of long-term (up to 160 weeks) dupilumab treatment * To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study * To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment * To evaluate the impact of dupilumab treatment on EoE signs and symptoms
This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic esophagitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.