Crohn's Disease Research Study
Researchers at the University of Florida are conducting a study on an investigational regulatory T‑cell therapy for adults with Crohn’s disease who still have active bowel inflammation despite prior treatments.
Fast Facts
Adults with Crohn’s Disease Who Have Tried Treatments Without Success
18-65
Years Old
Compensation
Provided Up To $2300
Conducted in
Gainesville, FL
Study Background
A potential new approach to restoring immune balance in Crohn’s disease
Crohn’s disease can cause the immune system to become overactive, which leads to ongoing inflammation, pain, and persistent symptoms even after trying multiple advanced therapies. The RESTORE Study is evaluating TRX103, an investigational therapy made from regulatory T cells (Tregs). These cells are designed to help calm the immune system and reduce inflammation in the gut. Researchers want to understand whether this therapy can safely support healing and improve symptoms for people whose Crohn’s disease remains active.
Adults ages 18 to 65 who have had Crohn’s disease for at least one year and still have active bowel inflammation may qualify. Participants may receive a single dose or multiple doses of TRX103 through an IV infusion and will be followed for about 12 months. All study-related care, including the investigational treatment and required procedures, is provided at no cost. Travel support is available for those who qualify.
Study Background
A potential new approach to restoring immune balance in Crohn’s disease
Crohn’s disease can cause the immune system to become overactive, which leads to ongoing inflammation, pain, and persistent symptoms even after trying multiple advanced therapies. The RESTORE Study is evaluating TRX103, an investigational therapy made from regulatory T cells (Tregs). These cells are designed to help calm the immune system and reduce inflammation in the gut. Researchers want to understand whether this therapy can safely support healing and improve symptoms for people whose Crohn’s disease remains active.
Adults ages 18 to 65 who have had Crohn’s disease for at least one year and still have active bowel inflammation may qualify. Participants may receive a single dose or multiple doses of TRX103 through an IV infusion and will be followed for about 12 months. All study-related care, including the investigational treatment and required procedures, is provided at no cost. Travel support is available for those who qualify.
Additional Information
This study is being done to learn whether TRX103, an investigational regulatory T‑cell therapy, can safely reduce gut inflammation, help the bowel heal, and improve symptoms in people with Crohn’s disease who have not responded well to other advanced treatments. Researchers also want to better understand how this therapy affects the immune system over time.
You may qualify for this study if you:
- Are 18 to 65 years old
- Have been diagnosed with Crohn’s disease for at least one year
- Currently have moderate to severe symptoms such as diarrhea (with or without blood), urgency, or incontinence
- Have tried at least two advanced therapies, such as biologics or TNF blockers, without enough improvement
- Weight 40 kilograms (88 pounds) or more
- Are able to travel to the University of Florida for study visits
- Are not currently pregnant
- Do not have a diagnosis of ulcerative colitis
Pre-screening and screening: You’ll first answer questions about your health and medical history to see if you may qualify. If you move forward, you’ll have screening visits that may include physical exams, blood tests, and other assessments to confirm eligibility.
Study enrollment: If you qualify and choose to join, you’ll be assigned to either a single‑dose or multi‑dose TRX103 group.
Study treatment: You’ll receive TRX103 by IV infusion at the study site according to your assigned dosing schedule. Study staff will monitor you closely during and after each infusion.
Follow-up visits: Over about 12 months, you’ll attend regular study visits (approximately 20–23 total, depending on your group) for exams, lab tests, and questionnaires about your symptoms and overall health.
Daily diary: You’ll be asked to complete a brief daily diary about your symptoms, well‑being, and medications.
Additional safety checks if needed: If your study doctor has any concerns, you may be asked to come in for extra visits or tests to ensure your safety.
Participants may receive up to $2300 dollars for participating in this study. This amount includes $100 dollars for each completed study visit, with approximately 23 visits in total, depending on the dose schedule you are assigned to. You may also be reimbursed for necessary transportation expenses that occur as a result of attending study visits. All study-related care is provided at no cost.
There is no cost for you to participate in our research study.