(BPT) - Sponsored by Merck

Crohn's disease (CD) is a chronic condition that affects approximately 1 million people living in the U.S.¹ Research shows that the disease has become increasingly common in the U.S. and other parts of the world, yet experts don't know why.¹

CD is a type of inflammatory bowel disease (IBD) that causes inflammation (swelling) and ulcers (sores) in the digestive tract.¹ CD accounts for approximately 40% of IBD cases.^2,3

Your digestive tract digests and moves food through your body. It includes your⁴:

• Mouth
• Esophagus (the tube that connects your mouth to your stomach)
• Stomach
• Small intestine
• Large intestine, which includes your colon, rectum and anus

What causes CD?

In CD, the body's immune system overreacts and damages healthy tissues in the digestive tract.⁵ It most often happens in the small intestine and the beginning of the large intestine. However, CD can happen in any part of the digestive tract.¹ Though experts don't know exactly what triggers CD, research shows that it may be due to a combination of immune system changes, genes and lifestyle factors.⁵

"Researchers are evaluating the safety of an investigational medicine and how well it may work in resolving or improving Crohn's disease symptoms compared to placebo in a clinical trial happening now," said Dr. Ahmed Kurdi, gastroenterologist and principal investigator at Sanford Health. "You or a loved one may be eligible to participate based on the inclusion criteria."

Join a clinical trial for CD

A clinical trial, also called a clinical study, is a type of research designed to learn more about how the body responds to investigational medicines, vaccines, or other treatments.

There is a clinical trial studying an investigational medicine for moderate to severe CD. Moderate to severe CD means symptoms happen more often or are more intense compared to mild CD, often leading to additional complications and greater impact on daily life.⁶

The goal of this trial is to learn if the investigational medicine is safe and works well to improve CD symptoms compared to a placebo.⁷ A placebo looks like the trial medicine but has no medicine in it. Using a placebo helps researchers better understand the effects of the investigational medicine.

This trial is for adults who⁷:

• Are between ages 18 and 80
• Have had CD for at least 2 months and currently have moderate to severely active CD
• Have had at least 1 of the below:
  • Have not responded well or stopped responding to at least 1 CD treatment
  • Have not tolerated their dose of corticosteroids (such as prednisone, budesonide, or beclomethasone) being reduced
  • Have not been able to tolerate taking at least 1 CD treatment

The importance of representation in clinical trials

Representation in clinical trials helps researchers gain a more complete picture of how investigational medicines work across populations. This helps support the development of safe and effective medicines for those who are most affected by the disease or condition being studied. Today, only 24% of clinical trial participants are from communities of color despite making up more than 40% of the U.S. population and facing higher burdens of many diseases.⁸

"Communities of color haven't always been equally represented or treated in healthcare," said Dr. Kurdi. "Acknowledging that history can open the door to honest conversations about clinical trial participation and provide access to research that may be relevant to their care."

More about this trial

There are more eligibility criteria for this trial. There may be risks related to participating in clinical trials. The trial doctor can discuss these with you.

Participation in clinical trials is voluntary, and participants are free to leave at any time, for any reason. Participants may or may not directly benefit from being in the clinical trial, but they will help researchers learn more about the investigational medicine and CD.

You can learn more about this clinical trial at Merck's clinical trial page.

References

1. National Institute of Diabetes and Digestive and Kidney Diseases. Definition & facts for Crohn's disease. Updated October 2025. Accessed May 1, 2026. https://www.niddk.nih.gov/health-information/digestive-diseases/crohns-disease/definition-facts
2. Crocetti E, Bergamaschi W, Russo AG. Population-based incidence and prevalence of inflammatory bowel diseases in Milan (Northern Italy), and estimates for Italy. Eur J Gastroenterol Hepatol. 2021;33(1S suppl 1):e383-e389. doi:10.1097/MEG.0000000000002107
3. Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165(5):1197-1205.e2. doi:10.1053/j.gastro.2023.07.003
4. Cleveland Clinic. What is the digestive system? October 25, 2024. Accessed June 16, 2026. https://my.clevelandclinic.org/health/body/7041-digestive-system
5. Cleveland Clinic. Crohn's disease: What it is, symptoms, causes & treatment. December 4, 2023. Accessed May 1, 2026. https://my.clevelandclinic.org/health/diseases/9357-crohns-disease
6. CrohnsAndColitis.com. Crohn's disease severity and progression. Accessed July 8, 2026. https://www.crohnsandcolitis.com/crohns/severity-and-progression
7. Merck Clinical Trials. A study to evaluate the efficacy and safety of tulisokibart in participants with moderate to severe Crohn's disease. Accessed May 7, 2026. https://www.merckclinicaltrials.com/trial/nct06430801/
8. Merck. Let's Talk Trials. Accessed May 27, 2026. https://www.merckclinicaltrials.com/Lets-Talk-Trials/