Clinical Trials

Evaluation of TOF FDG PET-MRE for identification of predominantly fibrotic small bowel strictures in Crohn’s disease.

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active Crohn's disease (CD) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

The purpose of this study is to determine if taking an increased sampling of mesentery (fatty tissue next to the intestine) and lymph nodes at the time of the subject's ileocolic resection prevents a 4-6 month recurrence of Crohn's disease at the site of the new connection.

This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.

This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ...

The purpose of this study is to compare the effectiveness of ultrasound with magnetic resonance (MR) enterography in the diagnosing and monitoring of Crohn's disease.

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical ...

The purpose of this study is to perform quantitative testing of a novel stricture patient-reported outcome (PRO) tool, including validation and assessment of responsiveness. Also, to assess responsiveness of the MRI-based stricture radiology index (SRI) items.

The study will estimate observer performance for Low-dose CT enterography ( LD-CTE) for detection of ileal inflammation due to Crohn’s disease. It will also determine if an LD-CTE technique using multi-step kV selection and automatic exposure control can routinely acquire volumetric datasets at radiation doses similar to or less than annual background radiation levels. Furthermore, the study will determine if LD-CTE  with or without ileocolonoscopy is better than validated patient symptom scores (using the Short Pediatric Crohn’s Disease Activity Index, short PDAI) in identifying patients with moderate to severe ileocolic Crohn’s disease who may benefit from treatment with biologic agents.

The purpose of this study is to evaluate perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).

The primary purpose of this study is to create a prospective registy of patients with pouch-related conditions to allow for longitudinal assesment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis ( CARP or CD of the pouch). 

The purpose of this study is to evaluate the effects of Remicade (infliximab) for the treatment of active Crohn's disease and  may be useful in preventing a relapse of Crohn's disease after surgical resection.

The purpose of this study is to test the effectiveness and safety of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease.

The purpose of this study is to evaluate the effects of oral antifungal treatment with posaconazole on disease activity and the burden of Malassezia spp. in CD patients with the CARD9 S12N allele. Further, this project will investigate the hypothesis that the microbial changes induced by antifungal treatment are associated with dampened downstream immune responses in those with a genetic predisposition to developing strong immune responses to Malassezia.  

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed Crohn's Disease (CD) stratified at higher risk for complications.

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by an Open Label Extension. Participants who complete the Blinded Treatment Period will be eligible to enroll in the optional Open Label Extension for an additional 44 weeks.

The purpose of this study is to compare a limited magnetic resonance enterography (MREN) to routine MREN in order to determine non-inferiority, missed findings, patient tolerance and impact on patient management. 

The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of giving repeat doses of ABT-494 to treat patients who have Crohn's disease.

The purpose of this study is to evaluate the effectiveness and safety of MEDI2070 in subjects with moderate to severe crohn's disease who have failed or are intolerant to anti-tumor necrosis-factor-alpha therapy.

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The purpose of this study is to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active crohn's disease

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).

This is an investigational study, also known as LATTICE-CD, of the experimental medication BMS-986165 in participants with moderate to severe Crohn's Disease, a chronic bowel disease that causes severe inflammation of the digestive tract.

The primary objective of this study is to evaluatge whether ustekinumab induces a similar proportion of pediatric participants with moderate-to-severe, active Crohn's disease into clinical remission at Week 1-8 compared with the proportion observed in adult participants with moderate-to-severe, active Crohn's disease randomized to ustekinumab in the CNTO1275CRD3001 and CNTO1275CRD3002 studies.

This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (CDAI score < 150) at week 8 (primary endpoint). After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 80% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, subjects will enter an open-label period during which all ...

The purpose of this study is to evaluate if specific blood, stool and MRI tests can tell the difference between bowel wall inflammation without scarring and bowel wall inflammation with scarring that can cause bowel blockages requiring surgery.

The purpose of the study is to evaluate the efficacy and safety of VR to treat abdominal pain in patients with quiescent Crohn's disease and assess the global and individual symptoms of Crohn's disease using validated instruments Patient Reported Outcomes Measurement Information System Pain scales, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment, and Short Inflammatory bowel disease questionnaire.

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).

The primary purpose of this study is to create a prospective registry of patients with pouch-related conditions to allow for longitudinal assessment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis (acute pouchitis, CADP, CARP, or CD of the pouch).

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure ...

The purpose of this study is to evaluate how well risankizumab works compared to ustekinumab to treat Crohn's disease.

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. 

The purpose of this study is to evaluate the effectiveness, safety, pharmacokinetics (PK), and immune response of high and low doses in 3 different weight groups of vedolizumab intravenous (IV) for maintenance of remission in children aged 2 to 17 years, inclusive, who weigh ≥ 10 kg with moderately to severely active Crohn’s disease (CD).

The purpose of this study is to assess the effectiveness of a new ultrasound technology for evaluating Crohn's disease.

The study consists of 3 sub-studies, as follows: 

Sub-study 1 (Randomized, double-blind, placebo controlled study)

• The purpose is to evaluate the effectiveness and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately-to-severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991.

Sub-study 2 (Randomized, exploratory maintenance study)

• The purpose is to evaluate the effectiveness and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active CD who responded to induction treatment in Study M16-006 or Study M15-991.

Sub-study 3 (Open-label, long-term ...

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

The overall objective of this proposal is to evaluate the potential therapeutic benefit of a whole-food, plant-based (WFPB) diet in patients with Crohn’s disease (CD). Our hypothesis is that patients adhering to WFPB diet will achieve higher rates of clinical remission and reduction in intestinal inflammation, as compared to controls who will implement FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet.  In order to further understand the pathogenesis by which diet may influence CD, we will also plan to study how WFPB may induce changes in the gut microbiota and intestinal permeability. We will test these hypotheses through ...

The purpose of this study is to assess the effectiveness of a new multi-parameter ultrasound technology for evaluation of Crohn’s disease.

To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition ...

The objectives of this study are to perform measured testing of the stricture PRO tool, including validation and assessment of responsiveness, and to assess responsiveness of the magnetic resonance image-based stricture radiology index (SRI) items.

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

This study will evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.

The purpose of this extension study is to monitor the safety and effectiveness of etrolizumab treatment in patients with moderate to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.

This study will evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease.

The purpose of this study is to understand and document the concepts relevant and important to the measurement of signs, symptoms, and related experiences of patients living with stricturing CD for development of a new PRO instrument.

The purpose of this study is to define and genotype the immunomodulatory properties of mesenchymal stem cells (MSCs) from Crohn’s disease subjects as compared to healthy/control subjects (diverticulitis, ulcerative colitis or subjects with perianal disease including hemorrhoids, cryptoglandular fistula, anal fissure, anal skin tags) or colon and rectal subjects.

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their ...

The purpose of this study is to determine whether AVB-114 compared to standard of care treatment is effective in inducing remission of the treated complex perianal fistula in subjects with Crohn’s Disease. It also aims to assess clinical and radiologic components of fistula remission, safety of treatment, disease activity, patient Quality of Life, and patient care journey, between AVB-114 and standard of care treatment.

We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education.

The purpose of this study is to create a group of blood and urine samples and quality of life data from Mayo Clinic patients with a diagnosis of inflammatory bowel disease (IBD). The blood and urine samples and quality of life data will be used for future research of IBD at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.

The purpose of this study is to demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) learning health system approach that enables patients and their care teams to coproduce optimal health and high value care.

The purpose of this research study is to collect clinical information and human samples from patients with IBD. The data collected will be used to create an organized, accessible resource of human samples for biological research in IBD.

The focus of the proposed study is to improve understanding of the underlying mechanisms of symptom burden, and the purpose is to describe how sleep health contributes to symptoms and functional performance in adults with Inflammatory Bowel Disease (IBD).

The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.

The purpose of this research study is to assess women who are diagnosed with Inflammatory Bowel Disease (IBD) and study the combination of using usual medical treatment with a wellness program designed just for women with IBD and the effect it has on quality of life, stress, and their symptoms

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications ...

The focus of this study is to retrospectively examine the patterns of use of biological agents and risk factors for discontinuation of these agents in pediatric Crohn’s disease (CD) and ulcerative colitis (UC) within the ICN network.  This will be a retrospective longitudinal observational cohort study.  The study population for the first portion of the study (Aim 1a below) will be all CD and UC patients in ICN who were diagnosed with IBD prior to age 18. This population will be queried for biologic use prior to age 18. The study population for the remainder of the study will be ...

The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).

The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.

This study will be a multi-center, longitudinal, observational investigation to collect biospecimens (blood, stool and intestinal biopsies) to support the development of specific biomarkers of treatment response to infliximab and vedolizumab in children with IBD.

The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.

The purpose of this study is to understand the impact of the COVID pandemic on IBD patients, including infection rates and complications from SARS-COV2, IBD related flares, patient compliance with biologic agents, impact of lockdowns on access to IV infusion centers, need for steroid therapy and admissions for IBD related flares, and modification of medical management.

The purpose of this study is to determine if WATS 3D (The Wide Area Transepithelial Sample with three dimension analysis) can be used to adequately sample the colon and identify dysplasia in patients with Irritable Bowel Disease (IBD) undergoing surveillance. 

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications ...

The purpose of the study is to:

• Map and compare the neoplasia-associated epigenetic field in IBD-CRN, sporadic CRN and controls.  
• Measure sensitivity of DNA methylation for the detection of synchronous IBD-CRN as a complement or alternative to histologic diagnosis of dysplasia on random biopsies. 
• Measure the density and types of lymphocytes infiltrating IBD-CRN tumors, sporadic tumors and the epigenetic field.