Clinical Trials for Crohn's Disease

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Crohn’s Disease from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 27
• Active, not recruiting: 6
• Completed: 5
• Other: 12

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT00001184 — Immune Regulation in Ulcerative Colitis or Crohn s Disease

This study will investigate in patients with Crohn s disease and ulcerative colitis how the body s immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments.

Patients between the ages of 0 and 75 years of age …

NCT03167437 — An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab

Background:

Crohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce the inflammatio…

NCT04372108 — 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).

NCT07686406 — IBD Biomarker Discovery and Validation Platform

The goal of this observational study is to establish a multicenter prospective clinical and biospecimen platform for biomarker discovery and validation in inflammatory bowel disease, including Crohn’s disease and ulcerative colitis.

Researchers want to learn whether candidate biomarkers or combined biomarker models can help assess intestinal inflammation, monitor response to routine clinical t…

NCT06956703 — NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants.

The main question it aims to answer is:

Are there differences in inflammatory markers between IBD and non-IBD (control) participants.

NCT06233461 — A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn’s Disease

Crohn’s disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn’s disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel c…

NCT05923073 — A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn’s Disease

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn’s Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

NCT06045754 — A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn’s Disease

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn’s Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment.

The study is conducted in two parts. In Part A, participants will receive the…

NCT06226883 — A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn’s Disease

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).

NCT06663332 — A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn’s disease, or juvenile psoriatic arthritis (jPsA).

NCT06819878 — A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn’s Disease

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).

NCT06819891 — A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn’s Disease

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

NCT06937099 — Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn’s Disease and Obesity or Overweight

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.

NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

The purpose of this study is to characterize participants with Crohn’s Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexual…

NCT07184931 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn’s Disease

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…

NCT07196722 — 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).

NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn’s Disease in the United Kingdom (UK)

The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn’s Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel …

NCT07310095 — 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.

NCT07545317 — Real-World Study of IL-23 Inhibitors in Active Crohn’s Disease

The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn’s disease in real-world clinical practice. The main questions it aims to answer are:

• What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?
• What are the clinical, endoscopic, biomarker, imaging, …

NCT07499232 — 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).

NCT07483073 — 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 leas…

NCT07483099 — A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn’s Disease

The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn’s disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.

NCT07541261 — A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn’s Disease in Saudi Arabia

The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe crohn’s disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of t…

NCT07577843 — 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).

NCT07616687 — Optimal Care With Guselkumab in Crohn’s Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study

Crohn’s disease (CD) is a chronic and destructive inflammatory disease of the gastrointestinal tract characterized by phases of relapse and remission. Tumor necrosis factor (TNF) antagonists, anti-integrins and anti-interleukin (IL) 12/23 are the main therapeutic agents to obtain deep remission and prevent disability. Despite the significant advances these biologics represent in treating inflam…

NCT07680283 — Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD

This is a Phase II, single-center (Cleveland Clinic), two-arm, randomized, parallel-group superiority trial. The two arms will compare IOUS-guided margin selection against standard macroscopic margin selection in patients undergoing ileocolic resection for terminal ileal Crohn’s disease. Patients and outcome assessors (pathologists, endoscopists) will be blinded to the intervention arm, while s…

NCT07691138 — Stopping PPI Therapy in Inactive IBD

To investigate the feasibility of proton pump inhibitor (PPI) withdrawal in inflammatory bowel disease (IBD); the data collected will provide valuable information to inform a future multi-centre randomised controlled trial.

Evidence suggests that patients with IBD taking PPIs respond less well to medication and require hospital treatment more frequently than patients not taking PPIs. This may …

Active, Not Recruiting

NCT00606346 — A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be directed to recording safety outcomes reported in association with infliximab and other prescribed IBD therapies. In addition, information on disease status and quality of life will be collected.

NCT03466411 — A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn’s disease.

NCT05092269 — 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

NCT05242471 — A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn’s Disease

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

NCT05347095 — A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn’s Disease

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn’s disease and to assess the overall safety of guselkumab.

NCT06408935 — Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn’s Disease Patients

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

Not Yet Recruiting

NCT07686757 — INSIGHT-IBD Pragmatic Study

The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.

The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn’s disease (CD) receiving care in community gastroenterology practices in the United States.

The main questions it aims to answer are:

• Does treatm…

NCT07654751 — A 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.

NCT07456566 — Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease

This research is studying whether changing an individual’s behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.

The study team hypothesizes:

• the study will achieve a recru…

NCT07677514 — A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn’s Disease

This study employs a multicenter, randomized, double-blind, placebo-controlled, parallel-group, continuous treatment design to evaluate the efficacy, safety, PPK characteristics, and PD effects of H021 Enteric-coated Tablets during both the induction and maintenance treatment periods in patients with moderately to severely active CD.

This study consists of an up to 4-week screening period, a 1…

NCT07619547 — Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease

Background:

Inflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn’s disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contr…

NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn’s Disease

Crohn’s disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib’s mechanism of action in CD and evaluate how safe this treatment is.

The partic…

NCT07672574 — Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers

This is an open, two-part study in healthy male volunteers, aged 30-65 years.

This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine ([14C]ontunisertib) and determine the routes and rates of elimination of the test medicine.

NCT07240649 — Emerging Indications for Hyperbaric Oxygen Treatment

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The re…

NCT07682038 — Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals

This multicenter retrospective real-world data study will evaluate the treatment pathways and disease burden of adult patients with Crohn’s disease (CD) and ulcerative colitis (UC) treated in 5-10 Dutch hospitals between 2018 and 2026.

The study will assess:

• Treatment sequences, switching patterns, and treatment duration
• Prevalence and incidence of extra-intestinal manifestations (EIMs) *…

NCT07683325 — NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn’s Disease

Many patients with Crohn’s disease (CD) develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the efficacy, safety, and dose-response relationship of ontunisertib in participants w…

Enrolling by Invitation

NCT06424769 — Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management

The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition if they have access to text messaging with their clinical team and if their symptoms are more regularly monitored through text-based surveys.

Researchers will compare participants who have access to text-based monitoring, communication and education to…

Completed Trials

NCT01155362 — PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn’s Disease

This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn’s disease. Three PDA001 dose levels were evaluated.

NCT04002180 — Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn’s Disease]

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.

NCT04245215 — Loss of RESponse to Ustekinumab Treated by Dose Escalation

The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn’s disease who show a secondary loss of response over time

NCT06094608 — IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms

This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.

NCT07508592 — Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

This is a first-in-human feasibility study designed to evaluate the safety and performance of the SEGER device in patients undergoing elective laparoscopic gastrointestinal surgery requiring intracorporeal anastomosis.

The study will include patients undergoing procedures such as small bowel-small bowel and colorectal anastomoses. The SEGER device is intended to facilitate closure of enterotom…

Other (Terminated)

NCT04173273 — A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn’s disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up…