Crohn's disease is a chronic inflammatory bowel disease affecting about 500,000 Americans. Current treatments include anti-inflammatory drugs, immune suppressants, and biologic therapies that target specific inflammatory pathways. Many people achieve remission with existing medications, but about 30% still require surgery within ten years of diagnosis.
What's actually going on in research
Trials are testing new biologic drugs that block inflammatory proteins like IL-23 and IL-36, oral JAK inhibitors that work inside immune cells, stem cell therapies for fistulas, and drugs targeting the gut lining itself. Researchers are also studying how to predict which patients will respond to which treatments, and whether treating early can prevent complications.
IL-23 inhibitors
These biologics target a specific inflammatory pathway and appear to work in people who haven't responded to anti-TNF drugs like adalimumab. Several are FDA-approved for Crohn's disease, with more in testing.
JAK inhibitors
Oral pills that block inflammation inside immune cells, offering an alternative to injections or infusions. Upadacitinib received FDA approval for Crohn's disease in 2022.
Fistula treatments
Stem cell therapy delivered directly into fistula tracts aims to heal these painful complications. Studies are also testing combination approaches with existing biologics.
What to know before you search
Eligibility typically depends on disease severity measured by symptoms and endoscopy, location of disease in the digestive tract, prior treatments tried, and presence of complications like fistulas or strictures.
What types of trials are currently open
- Biologic trials — Testing new antibody treatments that target different parts of the immune system. Usually given by injection or infusion.
- Oral medication trials — Testing pills like JAK inhibitors or other small molecules that can be taken at home instead of requiring infusions.
- Fistula trials — Testing stem cell therapy or other approaches to heal the abnormal tunnels that form between the intestine and other organs.
- Combination trials — Testing whether using two drugs together works better than one alone, especially for people with severe disease.
- Observational studies — Following people with Crohn's disease to understand disease patterns, treatment responses, and long-term outcomes.
Recently added Crohn's Disease trials
Prediction of Postoperative Recurrence in Crohn's Disease
This multicenter prospective observational cohort study aims to develop and validate a multimodal prediction model for postoperative recurrence in patients with Crohn's disease. Patients with Crohn's disease who undergo intestinal resection will be enrolled and followed after surgery. Residual surgical tissue that would otherwise be discarded, together with routinely collected clinical data and biological samples, will be used for research. Multi-omics analyses, including single-cell transcriptomics and spatial transcriptomics, will be performed to identify biological features associated with postoperative recurrence. Participants with Crohn's disease will be followed for clinical, endoscopic, and imaging recurrence after surgery. The study will use data from a screening cohort to develop a prediction model and a validation cohort to evaluate the performance of the model. A control group consisting of patients undergoing intestinal resection for conditions such as colorectal tumors or diverticular disease will also be included for comparative molecular analyses. No treatment will be assigned by the study protocol. All treatment decisions will be made by the treating physicians according to routine clinical practice.
A Phase 1 Study of ATORM-C in Patients With Crohn's Disease
This Phase 1 study evaluates the safety and tolerability of ATORM-C in patients with Crohn's disease. ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Participants will receive a single dose of ATORM-C applied directly to a target intestinal ulcer during colonoscopy. The study will also explore the effect of ATORM-C on intestinal ulcer healing.
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