Clinical Research Directory

A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications. This is a fully remote (virtual) study. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).

A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis

The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis

The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

A Long-term Extension Study of Ustekinumab in Pediatric Participants

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.

Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients

The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.

Biomarkers to Predict and Monitor Response to Infliximab

The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohn's Disease (CD) that correlate with and can predict and monitor patients who will have a prolonged response to Infliximab so that personalized medicine can be applied to patients with CD.

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study

To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.

Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae

The goal of this clinical trial is to learn whether bowel preparation with Plenvu before surgery improves healing of complex anal fistula in adults aged 18 to 64 years with a fistula of cryptoglandular origin or associated with Crohn's disease. The main question it aims to answer is: \- Does bowel preparation before surgery increase the proportion of participants whose fistula is clinically healed 6 months after surgery? Researchers will compare participants who prepare the bowel before surgery with participants who receive no bowel preparation. All participants receive the same oral antibiotic regimen and one of three standard sphincter-preserving operations: ligation of the intersphincteric fistula tract (LIFT), autologous platelet-rich fibrin (Obsidian), or endorectal advancement flap. The operation is chosen individually by the surgeon as the most appropriate for each fistula, before randomisation. Participants will: * Be randomly assigned to bowel preparation or no bowel preparation * Undergo one fistula operation within the study * Attend follow-up visits 6 and 12 months after surgery, including clinical examination and 3D endoanal ultrasound at 12 months after surgery * Complete questionnaires on anal continence and quality of life

PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease

There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \[TNF\] alpha, anti-integrin, and anti-interleukin \[IL\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologics results in the highest percentage of patients with small bowel (ileal) Crohn's disease entering into endoscopic remission without needing corticosteroids at 1 year. Endoscopic remission means that the ulcers in the small bowel from Crohn's disease have healed. All treatments in this trial are approved by Health Canada. No experimental drugs will be included.

Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD

This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.

Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease

Difficult-to-treat inflammatory bowel disease (DTT-IBD) represents a heterogeneous group of patients with treatment-refractory, structurally complicated, postoperative, perianal, pouch-related, or psychosocially complex disease. This multicentre ambidirectional observational cohort will establish a longitudinal registry of adults with inflammatory bowel disease and systematically identify patients meeting prespecified DTT-IBD criteria. Clinical data will be reconstructed retrospectively and collected prospectively using a common data dictionary, including disease phenotype, advanced-therapy exposure and failure, objective disease assessments, multidisciplinary decision-making, treatment implementation, surgery, hospitalization, and long-term outcomes. The registry will characterize the occurrence, clinical domains, treatment trajectories, longitudinal disease-control states, and outcomes of DTT-IBD. No treatment, diagnostic test, dose, surgery, or monitoring procedure will be assigned by the study. Clinical management will remain entirely at the discretion of the treating physicians and patients. The platform is designed to support prespecified nested studies addressing treatment-failure mechanisms and clinical decisions, longitudinal DTT trajectories and cumulative uncontrolled disease, and implementation of multidisciplinary care.

Addressing Disability Effectively With Psychosocial Telemedicine

This multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with IBD to complete a baseline survey and enroll those with higher scores on a validated IBD-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with a licensed psychologist versus usual care. The investigators aim to lay the foundations that will shift the paradigm of IBD clinical practice towards a new horizon of holistic and equitable high-value care.

Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders. In Japan particularly, the incidence of anal lesions is high, with approximately half of patients developing fistulas or abscesses, significantly impairing quality of life (QOL). For perianal fistulizing Crohn's disease (PFCD), combined treatment with surgical intervention (e.g., seton placement) and medical therapy centered on anti-TNF agents is standard. However, challenges remain regarding efficacy rates and evaluation criteria. Novel therapies such as stem cell therapy, JAK inhibitors, and IL-23 inhibitors are gaining attention. This study using risankizumab aims to be the first in Japan to comprehensively evaluate the therapeutic efficacy of PFCD using both clinical and MRI assessments, thereby contributing to future treatment standardization and guideline development.

Validation and Clinical Impact of GLIM Criteria in Patients With Inflammatory Bowel Disease

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory conditions of the digestive tract that frequently lead to malnutrition. Malnutrition in individuals with IBD is associated with diminished quality of life, impaired treatment response, and higher rates of hospital admission. To standardize nutritional diagnosis, the Global Leadership Initiative on Malnutrition (GLIM) introduced a consensus framework combining phenotypic criteria (weight loss, low body mass index, and reduced muscle mass) and etiologic criteria (reduced food intake/assimilation and disease-related inflammation). The primary objective of this prospective observational study is to validate the diagnostic accuracy and sensitivity of the GLIM criteria in identifying malnutrition among hospitalized and ambulatory adult patients with IBD, using the Subjective Global Assessment (SGA) as the reference standard. Secondary objectives include determining the prevalence and severity of GLIM-defined malnutrition, evaluating its relationship with clinical, functional, and inflammatory parameters, and identifying clinical predictors of malnutrition in this population. Adult participants diagnosed with IBD presenting to the inpatient wards or outpatient clinics of Al-Rajhi Liver Hospital (Assiut University) will be enrolled. Participants will undergo initial nutritional risk screening using the Malnutrition Universal Screening Tool (MUST) for outpatients or the Nutritional Risk Screening 2002 (NRS-2002) for inpatients. Full nutritional assessment will be conducted via GLIM criteria and SGA. Additional evaluations will include anthropometric measurements (mid-arm muscle circumference and calf circumference), muscle strength testing via handgrip dynamometry, dietary intake assessment, routine laboratory panels (complete blood count, inflammatory markers, liver function tests, electrolytes, and fecal calprotectin), and endoscopic disease activity scores (SES-CD or Mayo endoscopic score) when clinically available.

A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )

The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity, in children diagnosed Crohn's disease (CD).