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Showing 1-20 of 159 trials
NCT06226883
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
NCT03646708
The small bowel (SB) is involved in \~70% of patients with Crohn's disease (CD). There is an unmet need for accurate and clinically meaningful methods to measure small bowel Crohn's Disease (SBCD) activity. This is particularly relevant as the field moves towards "treat-to-target" management strategies. The overall objective of this proposal is to establish that radiologic transmural response (TR) and a novel proteomic biomarker are accurate and clinically meaningful predictors of SBCD inflammatory activity and response to biologic therapy. To address this objective, we will establish a prospectively followed cohort of SBCD patients starting a new biologic therapy. These patients will be comprehensively phenotyped using state of the art MRE imaging, proteomic profiling and clinical disease activity indices. We will use this innovative approach of triangular phenotyping to address our central hypothesis that "Corticosteroid-free remission at 52 weeks after biologic therapy initiation is predicted by short term radiologic TR or early changes in serum proteomic biomarker profiles". Serum proteomic biomarker profiles will be evaluated using SOMAscanTM (SomaLogic, Inc., Boulder, Colorado, USA), a novel platform allowing high-throughput analysis of proteins through Slow Off-rate Modified DNA Aptamer (SOMAmer)-based capture array. Our preliminary data using SOMAscan identified a panel of 12 serum proteins whose differential expression pattern from Week 0 to week 6 after starting a biologic can predict week 14 clinical remission in SBCD patients. The significance of this proposal is that the development of an early predictive model using radiological and serum endpoints will facilitate a personalized algorithmic approach to identify patients with SBCD who will benefit from treatment escalation or change to a different biologic. Furthermore, it will be used to generate a tangible career tool of a prospectively enrolled patient cohort to further study radiologic and biomarker predictors of response in SBCD. This award will also enhance the career of the principal investigator by facilitating acquisition of an enhanced skill set in clinical research, bioinformatics and biomarker discovery.
NCT07184931
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
NCT07356232
This is a multicenter non-randomized prospective open label trial of partial enteral nutrition (PEN) among patients with active Crohn's disease (CD) starting standard of care advanced therapy. Our central hypothesis is that combination therapy of PEN and pharmacologic therapy is more efficacious than pharmacologic therapy alone and can be well-tolerated for patients. Participants will choose to either include PEN along with starting their advanced therapy or will choose not to include PEN. 80 participants will be recruited from 15 sites across the United States.
NCT05626088
The primary reason of this study is to observe current and past treatment in adult participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Brazil. There is no treatment involved in this study, this is only an observational review of past and ongoing treatment data relating to Vedolizumab treatment for IBD (including Ulcerative Colitis \[UC\] and Crohn's Disease \[CD\]).
NCT06918808
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
NCT07409376
This study is designed as a controlled trial to evaluate the efficacy of balloon-assisted enteroscopy-guided radial incision therapy for the treatment of stricturing small bowel Crohn's disease. The study aims to compare therapeutic outcomes, procedure-related complications, and recurrence rates in patients with stricturing small bowel Crohn's disease undergoing balloon-assisted enteroscopy-guided radial incision therapy. The results are expected to provide a novel and reliable treatment option for patients with stricturing Crohn's disease and to lay a foundation for improving disease-related symptoms and quality of life.
NCT07385131
This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel disease (IBD). This study is designed to optimize the prophylactic strategy prior to Infliximab treatment and advocate for risk stratification-based individualized prophylaxis regimens to avoid hormonal abuse. Additionally, it will construct a risk score using biomarkers to accurately identify high-risk populations in need of prophylaxis and establish a corresponding predictive model. The study is also intended to reduce the use of unnecessary medications, shorten infusion duration and alleviate the medical burden. It is expected to provide targeted clinical support during the early stage of the disease or the course of treatment, improve the efficacy and precision of individualized treatment for patients, and reduce the physical, psychological and economic burdens caused by ineffective treatment.
NCT04118088
The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.
NCT02998398
The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition
NCT06459297
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohn's disease. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for treating Atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), ulcerative colitis (UC), and Crohn's disease (CD). Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea. Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 52 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
NCT04002180
The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in Crohn's disease (CD) patients in the routine clinical setting.
NCT07315711
The study was designed as a prospective, observational study. Pediatric patients under 18 years of age scheduled for peripheral vascular access placement during day-case surgery or non-operating room anesthesia (NORA) will be included. The primary outcomes include time to successful vascular access, number of attempts, and number of interventions (defined as each new skin entry of the needle). These outcomes will be compared between two groups: those who receive vascular access with the aid of a vascular imaging device and those in whom such a device is not used.
NCT07309744
This is an open-label, Phase I, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD). The enrolled population consists of patients with refractory moderate-to-severe inflammatory bowel disease who have received multiple lines of biologic therapy. Two cohorts are established in the study to explore the optimal biological dose (OBD) for each indication: Cohort 1: Ulcerative Colitis Cohort Cohort 2: Crohn's Disease Cohort The study presets 3 dose groups, which are 3, 6, and 10×10⁶ CAR+T cells/kg respectively. The initial dose group is 3×10⁶ CAR+T cells/kg (Dose Group 1), and dose de-escalation or escalation may be conducted based on the assessment of the Safety Review Committee (SRC). It is expected that no more than 9 patients will be enrolled in each cohort.
NCT07263464
The goal of this observational study is to investigate the associations between tumor necrosis factor superfamily member 4 (TNFSF4) gene polymorphisms and the risk of Crohn's disease (CD), and to elucidate the impact of TNFSF4 gene variations on the CD clinical phenotype and the efficacy of ustekinumab (UST). The main question it aims to answer is: Does TNFSF4 polymorphism affect susceptibility to CD and the efficacy of UST in CD patients? Participants will have their blood drawn upon enrollment
NCT07118878
In patients with Crohn's disease (CD), fibrosis of the gastrointestinal (GI) tract can result in stricture (stenosis) formation and obstruction of the GI tract, causing obstructive symptoms and often requiring surgical intervention. There are currently no approved therapies for treating fibrostenotic Crohn's disease (FSCD) and therefore, there is an urgent need for safe and effective antifibrotic therapies. AGMB-129 has shown to be safe in healthy participants with single doses up to 1200 mg and multiple doses up to 200 mg twice daily (BID) for 10 days, and in FSCD patients with multiple doses up to 200 mg BID for 12 weeks. This Phase 1 study will explore the safety, tolerability, and pharmacokinetics (PK) of other daily doses of AGMB-129 in healthy participants to inform on dose selection (nominal dose and dosing frequency) for subsequent clinical trials.
NCT03992469
Crohn's disease (CD) is the major form of inflammatory bowel disease (IBD) affecting adults. It is a life-long disease characterized by chronic and relapsing inflammation of the gastrointestinal tract. CD has multiple clinical phenotypes and disease severities that determine which therapy the study team utilizes. Currently, there are numerous treatment options for subjects with moderate-severe CD, but few that are approved to treat and maintain remission for the one-third of patients who present with mild-to-moderate disease. The study team hypothesizes that Butanol Purified Food Allergy Herbal Formula-2 (B-FAHF-2) will be safe and effective for maintaining remission of mild-to-moderate CD and can fill this therapeutic void. CD affects 241 per 100,000 adults in the United States and the incidence in both adults and children has increased in the past 60 years. One such potential therapy is Food Allergy Herbal Formula-2 (FAHF-2) which was originally developed to treat food allergy and has received FDA investigational new drug approval under the botanical drug title for treating patients with multiple food allergies. A completed phase I study showed that FAHF-2 is safe and well tolerated. A Phase II trial revealed that a high pill burden with FAHF-2 caused poor compliance. A butanol purified form of FAHF-2 (B-FAHF-2) is a more concentrated form of FAHF-2 which has also received an IND (FDA IND#77,468) and reduces the pill burden and improves compliance. Interestingly, the herbal components in B-FAHF-2 have long been used in Traditional Chinese Medicine (TCM) to treat gastrointestinal disorders including colitis. The study team has shown that B-FAHF-2 non-toxically inhibits TNF-#, a major inflammatory cytokine involved in CD, as well as multiple other pro-inflammatory cytokines produced by human peripheral blood mononuclear cells (PBMCs) and intestinal mucosa from subjects with CD. In addition, the study team has shown that FAHF-2 prevents disease progression in a murine model of colitis. The study team hypothesizes that E-B-FAHF-2 will be safe and effective for treating mild-to-moderate CD and can fill this therapeutic void. The study team proposes to investigate the safety and tolerability of B-FAHF-2 in subjects with mild-to-moderate CD. The goal is to establish safety and tolerability and explore efficacy at maintaining remission in this select patient population. Importantly, the study team will also determine the immunotherapeutic effects of E-B-FAHF-2 on PBMCs and intestinal mucosa to determine if there are immunologic alterations that would indicate that controlled efficacy evaluations of E-B-FAHF-2 are warranted. The new IND number is 143453. The FDA has completed their safety review of this protocol and has concluded that the study team's clinical trial may proceed with the proposed clinical investigation for Crohn's disease.
NCT06100289
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times.
NCT05384080
The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab induction and maintenance treatment for IBD \[including Ulcerative Colitis (UC) and Crohn's Disease (CD)\].
NCT06510296
The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased IBD activity (i.e., gut-brain interaction). Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life (HRQoL). This has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing. The IBD Social Cognitive Model (IBD SCM) posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone. While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD, access and scalability of this form of support is not yet widespread, particularly in resource-limited settings. Though many people with IBD have significant psychological distress, mental health care is underutilized with cost cited as a barrier. The emergence of digital interventions in clinical practice presents an opportunity to address access, scalability, and cost barriers. However, current testing of digital interventions to address gut-brain interactions (digital mind-body intervention, DMBI) among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits. Individuals with limited resources and those from racial and ethnic minority groups (e.g. Black, Hispanic) often have socioecological factors, such as healthcare access and mental health stigma, that impede their use of psycho-behavioral resources. DMBI development informed by participatory research approaches are, therefore, critical to facilitate equitable engagement and utilization. Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance, mindfulness, and values-based approaches. Although high quality evidence demonstrates psychological improvement with DMBI in IBD, feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking.