Why Consider a Clinical Trial for IBD?

Crohn's disease and ulcerative colitis are the two primary forms of inflammatory bowel disease (IBD). Together, they affect millions of people, and despite advances in biologic therapy, many patients still experience flares, medication intolerance, or loss of response. Clinical trials exist to bridge that gap.

• Access to novel therapies: New therapies that are not yet FDA-approved or commercially available are only accessible by participating in clinical studies.
• Enhanced monitoring: Patients in clinical studies often fare better than patients who are not, because of the closer monitoring built into every protocol.
• Advancing science: When you volunteer to take part in a clinical study, you help doctors and researchers learn more about disease and improve health care for people in the future.
• Financial relief: Many trials cover study-related medical care at no cost, and health insurance is often not required to participate.

The Florida IBD Trial Landscape

Florida is one of the most active states for gastroenterology research. Academic medical centres such as the University of Florida's Southeastern Center for IBD, along with dozens of private research sites across Miami, Orlando, Tampa, and Jacksonville, regularly participate in multi-centre IBD studies.

As of early 2026, listings show at least 14 Crohn's disease clinical trials actively recruiting volunteers in Florida alone, spanning both adult and paediatric populations. Several ulcerative colitis studies are also enrolling concurrently, often at the same sites. That means wherever you live in the state—from the Panhandle to the Keys—there is likely a study within driving distance.

Step-by-Step: Finding the Right Trial

Step 1 — Talk to Your Gastroenterologist

Your GI specialist is the best starting point. If you are interested in becoming a part of ongoing research, ask your IBD specialist how you can contribute. Many gastroenterologists maintain current lists of enrolling trials and can match you with a study that fits your disease severity, treatment history, and personal preferences.

Step 2 — Search Authoritative Online Databases

Multiple free databases let you filter IBD studies by condition, location, and recruiting status. We detail the most important ones in the next section.

Step 3 — Contact the Study Coordinator

Once you identify a promising trial, reach out to the listed site coordinator. They will walk you through a pre-screening questionnaire and schedule an initial assessment.

Step 4 — Review the Informed Consent Form

Before you agree to participate, the study team will review all aspects of the research study with you. You will receive an Informed Consent Form that provides the study's purpose, assessments, procedures, potential benefits and risks, and precautions—in writing.

Step 5 — Complete Screening Procedures

Screening may include blood work, stool tests, endoscopy, and a review of your medical records. These tests confirm whether you meet the study's specific eligibility criteria.

Step 6 — Enroll and Begin Treatment

If you qualify, you'll be assigned to a treatment arm. Some studies are double-blind, meaning neither you nor your doctor will know which dose or medication you receive until the study ends.

Key Databases and Search Tools

Tips for Searching ClinicalTrials.gov

1. Enter your condition (e.g., "Crohn's disease" or "ulcerative colitis").
2. Set Status to "Recruiting."
3. Under Location, type "Florida" or a specific city like "Miami" or "Tampa."
4. Review the eligibility criteria, primary endpoints, and estimated study completion date.
5. Always talk with your health care provider before you participate in a clinical study.

Understanding Eligibility Criteria

Every trial specifies who can—and cannot—participate. Common eligibility factors for IBD studies include:

• Diagnosis: Confirmed Crohn's disease or UC, typically moderate to severe.
• Age range: Some studies enrol adults 18–80; others target paediatric participants aged 2–17.
• Treatment history: Many trials seek patients who have had inadequate response, loss of response, or intolerance to conventional therapies such as corticosteroids, immunosuppressants, or biologic agents.
• Disease activity scores: Researchers may require a minimum Crohn's Disease Activity Index (CDAI) score or a specific Mayo score for UC.
• Exclusions: Active infections, certain surgeries, pregnancy, or current use of specific medications may disqualify you.

Don't self-screen out. Even if you're unsure whether you qualify, contact the study coordinator—eligibility nuances are often more flexible than the posted criteria suggest.

What to Expect After You Enroll

Participation timelines vary. Some induction studies run 8–12 weeks, while maintenance extensions can last several years. For example, current paediatric UC studies evaluating upadacitinib include an 8-week induction phase followed by a 44-week maintenance phase, plus a potential 260-week open-label extension.

Typical participant responsibilities include:

• Taking the study medication as directed (oral tablets, injections, or IV infusions)
• Attending scheduled clinic visits for blood draws, imaging, and symptom assessments
• Keeping a symptom diary or completing electronic surveys
• Reporting any adverse events promptly

Many studies reimburse travel expenses and provide study-related treatment, assessments, and care at no cost.

Patient Safety and Your Rights

Participant safety is the top priority in every clinical trial. Before a research study can begin, a review board or ethics committee must review the research study. In the U.S., this group is called an Institutional Review Board (IRB), made up of doctors, scientists, and community members.

Key protections include:

• Informed consent: You'll understand every procedure before agreeing.
• Privacy: Your trial records use a code rather than your name, and your personal identity will never be disclosed.
• Right to withdraw: Participants are volunteers and may withdraw from a clinical trial at any time, for any reason.
• Standard-of-care guarantee: Federal guidelines and regulations require that patients enrolled in clinical studies receive the best therapy available, in addition to any new therapies being tested.

Therapies Currently Under Investigation in Florida IBD Trials

The IBD pipeline is more active than ever. Below are categories of investigational therapies you may encounter when searching for Florida-based trials:

JAK Inhibitors

Upadacitinib (RINVOQ) is already approved for adults with moderate to severe Crohn's disease and UC, and paediatric studies are now underway. Newer oral JAK-pathway agents like TAK-279 are in Phase 2/3 evaluation.

IL-23 Inhibitors

Risankizumab and mirikizumab represent the next generation of targeted biologics. Trials are currently assessing their long-term efficacy in both adult and paediatric Crohn's and UC populations.

Anti-TL1A Agents

Tulisokibart (MK-7240) targets TL1A, a cytokine implicated in both inflammation and fibrosis. It is being evaluated in participants with moderately to severely active Crohn's disease across multiple Florida sites.

S1P Receptor Modulators

Etrasimod is under investigation for moderately to severely active UC in adolescents, with treatment periods of up to 52 weeks plus long-term extensions.

Dual Targeted Therapy

A pioneering approach combining vedolizumab and upadacitinib (dual targeted therapy) is being tested to determine whether combination treatment reduces bowel inflammation and ulcers more effectively than monotherapy in adults with Crohn's disease.

Novel Small Molecules

Tilpisertib fosmecarbil (formerly GS-5290) is a new oral compound being evaluated in Phase 2 for moderate to severe ulcerative colitis, with the primary objective of achieving clinical response at Week 12.

Key Takeaways

• Florida hosts a robust network of IBD clinical trial sites—from university medical centres to private research organisations like EBG Clinical Research.
• ClinicalTrials.gov and the Crohn's & Colitis Foundation Trial Finder are the two most reliable starting points for locating studies.
• Always involve your gastroenterologist early; they can identify the trial best suited to your disease profile.
• Eligible participants typically receive study-related care, medication, and monitoring at no cost.
• You can leave a trial at any time—participation is entirely voluntary.
• The IBD drug pipeline is expanding rapidly, with JAK inhibitors, IL-23 blockers, anti-TL1A antibodies, and combination regimens all actively recruiting in Florida.

Frequently Asked Questions

How do I search for IBD clinical trials specifically in Florida?

Visit ClinicalTrials.gov, enter "Crohn's disease" or "ulcerative colitis" as the condition, set the status to "Recruiting," and type "Florida" under Location. You can also use the Crohn's & Colitis Foundation Clinical Trial Finder at trials.crohnscolitisfoundation.org, which pulls data from the same federal registry in a more patient-friendly interface.

Do I need health insurance to join a clinical trial?

In most IBD trials, health insurance is not required. Study-related treatment, assessments, and care are typically provided at no cost, and many trials also reimburse participants for travel.

Will I definitely receive the experimental drug?

Not necessarily. Many IBD trials are randomised and placebo-controlled, meaning some participants receive a placebo—an inactive version of the intervention designed to look the same as the active treatment. However, many modern trial designs include open-label extension periods so all participants eventually gain access to the active drug.

What types of Crohn's and UC drugs are being tested in Florida right now?

Active Florida studies include JAK inhibitors like upadacitinib and TAK-279, IL-23 inhibitors such as risankizumab and mirikizumab, the anti-TL1A antibody tulisokibart, S1P receptor modulators like etrasimod, and dual targeted therapy combining vedolizumab with upadacitinib.

Can children or teenagers participate in IBD clinical trials in Florida?

Yes. Several paediatric IBD trials are currently open in Florida for participants aged 2–17, evaluating medications such as upadacitinib, risankizumab, and mirikizumab for both Crohn's disease and ulcerative colitis.

Is it safe to join a clinical trial?

Clinical trials follow strict scientific and ethical guidelines. Before a study begins, an Institutional Review Board (IRB) composed of doctors, scientists, and community members must approve it. Participants can withdraw at any time, and privacy is protected by law.

How long do IBD clinical trials typically last?

It varies by study design. Induction phases typically run 8–12 weeks, while maintenance phases can extend 44–52 weeks. Open-label extensions may continue for several additional years, giving participants long-term access to the study treatment.