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This is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE). The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo on gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied. Study details include: The study duration will be up to 48 weeks (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension. The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension. The double-blind placebo-controlled treatment duration will be up to 28 weeks.
Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in wheat, rye, and barley. It is well known that many factors contribute to the development of CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we will consider as many of these factors as possible and study how they each contribute to disease development. If the investigators find that any one factor, or combination of factors, increases the risk of developing CD, we will be able to apply this information and help prevent or detect disease in high-risk children in the future.
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults. It will also look at how the body processes the drug. The main questions it aims to answer are: * What side effects do participants have after receiving HB-2121? * How much HB-2121 is in the blood over time? Researchers will follow participants for 30 days after receiving HB-2121 to understand how the drug behaves in the body and how safe it is. Participants will: * Receive one oral dose of HB-2121 * Attend 4 in-person clinic visits for checkups, lab tests, and monitoring * Complete 2 remote visits that include safety lab assessments * Fill out a short daily questionnaire for 7 days about symptoms and health status
The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease. The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease. A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease. The expected trial duration per participant is approximately 86 weeks.
GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.
The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.
Subjects include: aged 18 to 75 years, inclusive, have biopsy-confirmed disease that is clinically inactive as determined by negative celiac disease (CeD) serology and histology (determined via endoscopy at time of screening), have followed a gluten-free diet (GFD) for ≥6 months as reported by the subject, and be human leukocyte antigen (HLA)-DQ2.5 and/or HLA-DQ8 positive. Study involves the following randomized intervention; 10g gluten + 200mg of Ritlecitinib or placebo
The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.
This study aims to evaluate the EUS-RFA in terms of efficacy for pain management and improvement in quality-of-life parameters for patients with advanced inoperable pancreatic cancer. The primary objectives of this study are to 1) evaluate the utility of EUS-RFA for pain control and improvement in quality-of-life parameters for patients with advanced pancreatic cancer; 2) to measure the reduction of analgesic medications' requirements in patients affected by inoperable pancreatic cancer.