Crohn Disease Clinical Trials

171 recruiting

Understanding Crohn Disease Clinical Trials

Infliximab (Remicade), approved in 1998 after groundbreaking clinical trials, was the first biologic therapy for Crohn disease and revolutionized treatment by demonstrating that targeting the inflammatory protein TNF-alpha could heal the intestinal lining, not just reduce symptoms. Since then, trials have delivered additional biologics including adalimumab, vedolizumab, and ustekinumab, as well as the newer oral JAK inhibitor upadacitinib. Despite this growing treatment arsenal, approximately one-third of Crohn disease patients do not respond adequately to available therapies, and many who initially respond lose efficacy over time, making ongoing clinical trial research essential.

Why Consider a Clinical Trial?

Crohn disease is a chronic inflammatory condition that can affect any part of the gastrointestinal tract and often requires lifelong management. While current treatments can control inflammation in many patients, the experience of cycling through medications as they lose effectiveness is common. Patients may also develop antibodies to biologic drugs, experience intolerable side effects, or have disease in locations (such as the upper GI tract or perianal area) that responds poorly to standard therapies. Clinical trials offer access to treatments with novel mechanisms that may work where existing drugs have not. Beyond drug therapies, Crohn disease trials are also advancing our understanding of mucosal healing — the goal of not just controlling symptoms but fully repairing the intestinal lining, which is associated with better long-term outcomes. Trials are testing drugs that target new inflammatory pathways, combination strategies pairing biologics with other agents, diet-based interventions with scientific rigor, and even stem cell therapies for patients with complex fistulizing disease. For patients who feel they have exhausted their treatment options, trials frequently represent a meaningful next step.

Frequently Asked Questions

Common questions about Crohn Disease clinical trials

Some trials specifically enroll patients in remission to study maintenance strategies or to compare long-term outcomes between treatments. However, most trials for new therapies require that you have active disease, typically confirmed by endoscopy and elevated inflammatory markers. Your current disease status determines which trials are appropriate.

Most treatment trials for active Crohn disease require a recent colonoscopy or ileocolonoscopy to confirm inflammation and establish a baseline endoscopic score. This is typically performed within four to six weeks before enrollment. Some trials accept flexible sigmoidoscopy or capsule endoscopy depending on your disease location.

Yes. Pediatric Crohn disease trials exist, though they are fewer in number than adult trials. These trials have additional safety protections and ethical oversight specific to minors. Pediatric gastroenterology centers at academic hospitals are the best resource for finding trials open to younger patients.

Trial protocols have predefined plans for managing flares, which may include corticosteroid rescue therapy or dose adjustments. If the study treatment is not controlling your disease after a defined period, the protocol will typically allow you to exit the trial and return to standard care. Your safety and disease management remain the priority.

Several rigorous clinical trials are studying specific dietary interventions, including the Crohn Disease Exclusion Diet (CDED) and variations of exclusive enteral nutrition. These trials use standardized protocols and objective endpoints like endoscopic healing. While results are promising, dietary approaches are being studied as complements to, not replacements for, medical therapy.

Showing 120 of 171 trials

Recruiting
Phase 1

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

Malignant Solid NeoplasmHematopoietic and Lymphoid Cell NeoplasmRheumatoid Arthritis+11 more
National Cancer Institute (NCI)300 enrolled52 locationsNCT03816345
Recruiting
Phase 4

Combined Immunosuppression for Pediatric Crohn's Disease

Crohn DiseaseImmunosuppressionChildren, Only+1 more
Children's Hospital of Fudan University128 enrolled1 locationNCT05043870
Recruiting
Phase 4

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

Crohn Disease
Xian-Janssen Pharmaceutical Ltd.78 enrolled4 locationsNCT07310095
Recruiting
Not Applicable

Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy

Crohn Disease
Centre Hospitalier Universitaire de Nīmes30 enrolled2 locationsNCT06856044
Recruiting

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

Crohn DiseaseColitis Ulcerative
Janssen Scientific Affairs, LLC1,056 enrolled1 locationNCT04372108
Recruiting
Phase 2Phase 3

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

Crohn Disease
Janssen Research & Development, LLC1,092 enrolled324 locationsNCT07196722
Recruiting
Phase 2

Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease

Crohn DiseaseUlcerative Colitis (UC)IBD
Assistance Publique - Hôpitaux de Paris45 enrolled1 locationNCT07300553
Recruiting

Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.

Crohn Disease
Massachusetts General Hospital25 enrolled1 locationNCT06252493
Recruiting

Development of New Diagnostic Tools in Capsule Endoscopy

TumorCeliac DiseaseCrohn Disease+2 more
Assistance Publique - Hôpitaux de Paris10,000 enrolled1 locationNCT06152289
Recruiting

Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease

Crohn DiseaseStricture; BowelIntestinal Stricture
Second Affiliated Hospital, School of Medicine, Zhejiang University239 enrolled8 locationsNCT05387031
Recruiting
Not Applicable

Impact of Prebiotics in Ulcerative Colitis

Crohn DiseaseUlcerative Colitis
University of California, Los Angeles70 enrolled1 locationNCT06495658
Recruiting

Evaluation of Muscle Strength and Muscle Mass in Patients With Inflammatory Bowel Disease

Crohn Disease (CD)
Sakarya University100 enrolled1 locationNCT07441447
Recruiting
Early Phase 1

Effect of Statins on Crohn's Disease

Crohn DiseaseCrohn's Ileocolitis
Stanford University20 enrolled1 locationNCT06538649
Recruiting
Not Applicable

The Assessment of Infrared Treatment for Crohn's Disease

Inflammatory Bowel DiseasesCrohn DiseaseIBD
Shmuel Kivity, MD40 enrolled1 locationNCT06146816
Recruiting
Phase 4

Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease

Crohn Disease
Sixth Affiliated Hospital, Sun Yat-sen University214 enrolled1 locationNCT06520397
Recruiting
Phase 1Phase 2

Stem Cell Transplantation in Crohn's Disease

Crohn Disease
Cedars-Sinai Medical Center15 enrolled1 locationNCT04224558
Recruiting

Nutrition and Clinical Outcomes in IBD

SarcopeniaInflammatory Bowel DiseasesCrohn Disease+2 more
Barts & The London NHS Trust300 enrolled1 locationNCT06550310
Recruiting
Phase 2

HB-adMSCs for the Treatment of Crohn's Disease

Crohn Disease (CD)
Hope Biosciences Research Foundation46 enrolled1 locationNCT07077746
Recruiting

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

Ulcerative Colitis (UC)Crohn Disease (CD)Inflammatory Bowel Disease (IBD)+1 more
TIDHI Innovation Inc.200 enrolled9 locationsNCT07245394
Recruiting
Phase 2

Standardized Microbiota Transplant Therapy in Crohn's Disease

Crohn Disease
University of Minnesota120 enrolled1 locationNCT06631586