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IBD Clinical Trials in the US: What You Should Know

Alma writes these guides with AI, grounded on our curated trial data. It's educational — not medical advice. Please talk to your doctor before joining any clinical trial.

Hi — I'm Alma

Hi — I'm Alma. I put this guide together for you because navigating life with inflammatory bowel disease (IBD) is hard enough without having to decode the world of clinical research on your own.

If you or someone you care about is living with Crohn's disease or ulcerative colitis, you've probably wondered whether clinical trials might be worth exploring — maybe because current treatments aren't quite working, or because you want access to something newer. Whatever brought you here, this article is meant to walk you through the basics: what IBD actually is, what researchers are studying right now in the United States, and how to figure out if a trial might make sense for you.

No pressure. No jargon overload. Just a clear, honest look at where things stand.

What is inflammatory bowel disease?

Inflammatory bowel disease — IBD for short — is a term that covers two main conditions: Crohn's disease and ulcerative colitis. Both involve chronic inflammation in your digestive tract, but they show up differently and affect different parts of the gut.

Crohn's disease can strike anywhere along the digestive tract, from your mouth all the way to the end. Most commonly it affects the end of the small intestine (the ileum) and the beginning of the colon. The inflammation in Crohn's tends to be patchy — you might have a stretch of healthy tissue right next to a stretch that's inflamed — and it can go deep into the layers of the bowel wall. Symptoms often include persistent diarrhea, abdominal pain and cramping, fatigue, unintended weight loss, and sometimes fever. Some people develop complications like fistulas (abnormal connections between parts of the intestine or between the intestine and other organs), strictures (narrowing), or abscesses.

Ulcerative colitis is more focused. It affects the colon (large intestine) and rectum, and the inflammation is continuous — it starts at the rectum and extends upward in an unbroken stretch. The inflammation stays in the innermost lining of the colon rather than going deep into the wall. Symptoms include bloody diarrhea, urgency (feeling like you need to go right now), rectal pain, and cramping. In severe flares, people can become anemic, dehydrated, or lose significant weight.

Both conditions tend to follow a pattern of flares and remission — periods where symptoms are active and periods where they quiet down. The exact cause of IBD isn't fully understood, but it involves a combination of genetics, an overactive immune response, and environmental triggers. Your immune system essentially attacks the lining of your own gut, creating ongoing inflammation.

There's no cure for either condition yet. Current treatments — including anti-inflammatory drugs, immunosuppressants, biologic therapies, and sometimes surgery — focus on reducing inflammation, managing symptoms, and keeping you in remission as long as possible. For many people these treatments work well. But for others, the available options aren't enough, or they stop working over time. That's a big part of why research keeps pushing forward.

What's happening in IBD research right now

Right now, we're tracking 82 clinical trials focused on IBD across the United States. That's a significant amount of active research, and it spans a wide range of approaches — from novel drugs to dietary interventions to stem cell therapies.

In terms of study phases, there are 10 Phase 3 trials (the large-scale studies designed to confirm whether a treatment works), 18 Phase 2 trials (earlier-stage studies testing effectiveness and dosing), 11 Phase 1 trials (focused on safety in smaller groups), and 7 Phase 4 trials (post-approval studies that monitor treatments already on the market). A good number of studies fall outside traditional phase classifications — these include registries, biorepositories, and observational research that help scientists understand IBD on a deeper level.

The conditions being studied lean heavily toward Crohn's disease and ulcerative colitis, often with trials enrolling patients with one or both diagnoses. Some trials also address related conditions like indeterminate colitis or inflammatory arthritis associated with IBD.

Several big names are sponsoring research in this space. Takeda leads with 7 trials, including a Phase 3 extension study evaluating the long-term safety of vedolizumab (an integrin-targeting biologic) in pediatric patients with ulcerative colitis or Crohn's disease. Sanofi is running 4 trials. Eli Lilly and Company is involved in 3 studies. AbbVie is sponsoring research including a pregnancy exposure registry for risankizumab, an IL-23 inhibitor approved for Crohn's disease and other conditions. Pfizer has trials underway as well, including an open-label study of etrasimod — a sphingosine-1-phosphate (S1P) receptor modulator — in adolescents with moderately to severely active ulcerative colitis.

Academic medical centers are also deeply involved. The Mayo Clinic, the University of North Carolina at Chapel Hill, Stanford University, the University of Pittsburgh, Boston Children's Hospital, and the University of Texas Health Science Center in Houston are all running their own studies. These range from investigations into fecal microbiota transplantation for ulcerative colitis to studies on low-dose IL-2 therapy for Crohn's disease, nicotinamide riboside supplementation, fasting-mimicking diets, vitamin D supplementation for patients on biologics, and even bright light therapy to support intestinal barrier health.

One particularly striking area of research: autologous stem cell transplantation for severe, treatment-refractory Crohn's disease, with several Phase 1 and Phase 2 trials exploring this approach. There's also growing interest in understanding the role of the gut microbiome and metabolic health — including a Phase 2 trial at the University of California, San Diego looking at pharmacologic weight loss as an adjunct therapy for ulcerative colitis in obese patients.

The range of what's being studied is genuinely encouraging. This isn't just about one new drug — it's a whole ecosystem of ideas being tested.

What this means for you as a patient

If you're living with IBD and your current treatment isn't getting you where you want to be — or if you're simply curious about what's on the horizon — clinical trials are worth considering. They're not a last resort. They're one option among many, and they give you access to therapies that aren't available yet through your regular doctor.

Here are a few things to keep in mind:

  • You don't have to be "out of options" to explore a trial. Some studies enroll people who are on stable treatment, some look at newly diagnosed patients, and some focus on people who haven't responded to standard therapies.
  • Every trial has specific eligibility criteria. Your diagnosis, how active your disease is, what medications you've tried, your age, and other health conditions all play a role in whether you'd qualify.
  • Your safety matters. Clinical trials go through rigorous ethical review, and you always have the right to leave a study if you change your mind.
  • Ask questions. Good questions to bring up with your doctor or a trial team include: What phase is this study? What are the known side effects so far? Will I receive a placebo, and if so, what happens to my current treatment? How often will I need to come in for visits? What happens when the study ends?

Talking to your gastroenterologist about trials is a great first step. And if you want to get a clearer picture of which studies you might be eligible for — without committing to anything — that's exactly what our triage is designed to help with.

How Alma's triage works

We built a short guided chat to help you figure out which IBD clinical trials in the US might be a match for you. You'll find it on our IBD scope page.

Here's how it works: Alma asks you a series of simple questions — things like your specific diagnosis (Crohn's, ulcerative colitis, or both), where you're located, what treatments you've tried, and how active your symptoms are right now. Based on your answers, the system filters through the trials we're tracking and shows you the ones that are most likely relevant to your situation.

It takes just a few minutes. You don't need to create an account to get started, and you're never asked for information that isn't directly useful for matching you. Think of it as a first filter — a way to narrow down 82 trials to a handful that actually make sense for you.

Ready to explore your options?

If you're curious about whether a clinical trial might be right for you, the easiest way to start is with our triage. It's free, it's quick, and it's built around your answers — not assumptions.

Start the triage here → almastudies.com/ibd

Whatever you decide, I hope this guide gave you a clearer picture of where IBD research stands today. You deserve to know what's out there.

Start the triage in IBD
Written by Alma (AI) for Alma studies., grounded on our curated trial data. I'm not a doctor — please talk to yours. Last updated: 2026-04-20.