What is a clinical trial?

A clinical trial is a research study involving human participants designed to evaluate medical interventions — such as drugs, devices, or behavioral strategies. Trials follow a structured protocol and are registered on ClinicalTrials.gov. They progress through phases: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale comparison), and Phase 4 (post-market surveillance).

How do I find clinical trials I'm eligible for?

You can search ClinicalTrials.gov or use ClinicalMetric to filter by condition, phase, or location. Each trial listing includes eligibility criteria such as age range, sex, diagnosis, and prior treatment history. Contact the study team directly or ask your physician to refer you to a relevant trial.

Are clinical trials safe to participate in?

Clinical trials are conducted under strict ethical and regulatory oversight, including IRB approval and FDA regulation in the US. All participants must give informed consent after reviewing potential risks and benefits. Phase 1 trials carry more uncertainty, while Phase 3 trials involve interventions with an established safety profile. Participation is always voluntary and you may withdraw at any time.

What are the phases of clinical trials?

Clinical trials progress through four main phases. Phase 1 tests safety and dosing in a small group (20–80 people). Phase 2 evaluates efficacy and side effects in a larger group (100–300). Phase 3 compares the intervention against standard treatments in thousands of participants. Phase 4 occurs after approval and monitors long-term effects in the general population.

Do participants get paid for joining clinical trials?

Many clinical trials offer compensation for time and travel expenses, though payment structures vary widely by study. Compensation is not intended to be coercive. Some trials also cover treatment costs for participants. Always review the consent form carefully and ask the study coordinator about any financial considerations before enrolling.

Crohn's Disease Clinical Trials 2026: New Biologics, JAK Inhibitors & Gut Microbiome

Medical Notice

This article is for informational purposes only and does not constitute medical advice. Clinical trial eligibility and availability vary. Always consult a qualified healthcare professional before making any medical decisions or considering participation in a clinical trial.

Summary

Crohn's disease is a chronic inflammatory bowel disease affecting the entire gastrointestinal tract. Despite multiple approved biologics, up to 40% of patients lose response over time and many never achieve deep remission. In 2026, several new drugs have been approved or are in late-stage trials — including IL-23 inhibitors, JAK inhibitors, and sphingosine-1-phosphate receptor modulators. Research is also exploring combination biologic therapy and the gut microbiome's role in disease and treatment response.

Newly Approved and Late-Stage Drugs

Risankizumab (Skyrizi): IL-23 inhibitor approved for Crohn's in 2022. Phase 3 trials showed high rates of endoscopic remission — a more stringent endpoint than clinical remission. Post-marketing trials are studying positioning vs. other biologics.

Upadacitinib (Rinvoq): JAK1 inhibitor approved for Crohn's in 2023 — the first oral advanced therapy approved for Crohn's. Trials are comparing it to biologics as first-line therapy and studying its use after biologic failure.

Mirikizumab (Omvoh): IL-23p19 inhibitor approved for ulcerative colitis, with Crohn's Phase 3 data showing endoscopic response. Crohn's indication filing in progress.

Combination Biologic Therapy

A paradigm shift in IBD treatment is the exploration of combining two biologics with different mechanisms. The VEGA trial showed vedolizumab + guselkumab outperformed either agent alone in UC. Similar combination trials for Crohn's are now recruiting — combining anti-TNF with anti-IL-23, or anti-integrin with anti-IL-12/23. This approach was historically avoided due to infection concerns but is being revisited with careful safety monitoring.

Gut Microbiome and FMT Trials

Fecal microbiota transplantation (FMT) has been extensively studied in Crohn's, with mixed results. Standardized FMT products (SER-287 from Seres, RBX2660 from Ferring) are in trials. Research is focused on identifying the optimal donor microbiome composition and delivery method. A 2024 trial showed intensive FMT (weekly infusions for 8 weeks) induced remission in a subset of Crohn's patients.

Eligibility for Crohn's Trials

Most Crohn's trials require: confirmed diagnosis (endoscopic/histologic), active disease at screening (CDAI score, endoscopic findings, CRP/fecal calprotectin), and specific prior treatment history. Biologic-naïve vs. biologic-experienced populations are typically studied separately. Patients with stricturing or penetrating disease requiring surgery are often excluded from drug trials. Tuberculosis screening and hepatitis B testing are standard pre-enrollment requirements for biologic and JAK inhibitor trials.