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IBD Clinical Trials & Studies

Inflammatory bowel disease (IBD) refers to conditions that cause chronic inflammation of the digestive tract, of which Crohn’s disease (CD) and ulcerative colitis (UC) are the most common forms. As immune-mediated diseases, these conditions can significantly affect a person’s quality of life, often leading to symptoms such as diarrhea, abdominal pain, and weight loss, among others.1

Clinical trials play a crucial role in advancing care by exploring new treatments that aim to improve outcomes for patients with IBD and offer more options for long-term management.

Why are IBD Clinical Trials and Research Important?

As of 2019, approximately 4.9 million people across the globe are living with IBD.2

Despite available treatments, some people with IBD often experience unpredictable cycles of remission and relapse.3 Since IBD currently has no cure4, even when symptoms are under control, ongoing inflammation may persist, leading to flare-ups and highlighting the need for more effective therapies that offer sustained remission.3

Clinical trials for IBD, which includes Crohn's disease and ulcerative colitis, are essential as they provide evidence on the efficacy and safety of novel therapies through rigorously conducted studies.5

Crohn’s Disease

People with Crohn’s disease typically face delays in diagnosis of up to 2 years. As this disease is progressive, delayed diagnosis can potentially worsen outcomes for patients and increase the risk of complications.6,7

It can also be difficult to match treatments effectively, as different options are needed for the different forms of the disease.8

Despite the approval of multiple advanced therapies, many patients find that the medication doesn't work for them from the start or stops working over time.9

Ulcerative Colitis

Even though in recent years, advanced therapies have expanded treatment options for patients with ulcerative colitis, remission rates of only 20–30% are seen as of 2024.10

There is a lack of consensus on how to select advanced therapies for ulcerative colitis as well as available biomarkers to help doctors determine which therapy will work best for patients.10,11

Sanofi is dedicated to advancing investigator-sponsored studies and supporting externally led scientific collaborations. Learn more about our latest IBD research targeting the TL1A pathway.

Ulcerative Colitis trial

Sanofi’s Commitment to New IBD Research

Globally, the treatment landscape for IBD still faces several critical gaps, such as insurance-related delays and high costs for patients requiring specialty medications.12

Sanofi is focused on transforming treatment options by advancing a robust pipeline in immunology and inflammation. We prioritize patient-centric IBD research and development, designing clinical trials that reflect the diverse populations seen in real-world care. Learn more about our commitment to diversity in clinical trials.

Diversity in Clinical Trials

How are Patients Recruited for IBD Clinical Trials?

Recruitment for IBD clinical trials is a multistep rigorous process. Volunteers typically learn about clinical trials by suggestion from their healthcare provider or independent research from public sources, like the US Clinical Trials Registry. 

Once a volunteer expresses their interest to participate in a clinical trial, they are provided with a patient information sheet and an informed consent form. A member of the medical staff conducting the trials will explain the objectives of the clinical trial, the process and any potential risks. 

Not every volunteer interested in a clinical trial may be eligible for the study. Each clinical trial has specific inclusion criteria for participants based on factors like medical history, severity of condition, previous treatments used and more. When the prospective participant has signed the informed consent form, they undergo a process called clinical trial screening. The screening process involves a recommendation from a healthcare provider, medical history review, physical exams and diagnostic tests relevant to the clinical trial. 

If the volunteer is found to be eligible based on the screening results, they can move on to participating in the trial. All participants in a clinical trial are volunteers, and can withdraw at any point for any reason.

While clinical trial participation can come with risks, it can also come with benefits. Patients may gain early access to promising new treatments, receive close medical monitoring, and contribute to advancing future therapies. Clinical trials follow strict safety and privacy safeguards, are not limited to major hospitals, and do not require a doctor’s referral to join.

Learn more about the clinical trial recruitment process at Sanofi

Types of Clinical Trials for IBD

There are several different types of clinical trials for IBD, such as:13

  • IBD Treatment Clinical Trials: these trials test the safety and effectiveness of new medications, therapies, or surgical procedures for IBD.
  • IBD Prevention Clinical Trials: these trials involve people who are at high risk for IBD or who are in remission, and study ways to prevent the disease from developing or returning. Interventions may include medications, supplements, or other strategies.
  • IBD Diagnostic Clinical Trials: these studies explore new tests that may be faster, easier, or more accurate than current tools used to diagnose IBD.
  • IBD Screening Clinical Trials: these trials aim to improve early detection of IBD or its related complications, especially in individuals considered high risk.
  • IBD Genetic Clinical Trials: these trials investigate how genes are linked to IBD, helping researchers identify people who may be at risk or protected based on their DNA.
  • IBD Quality of Life Clinical Trials: these trials focus on improving day-to-day life for patients with IBD, such as managing side effects, diet, lifestyle, and coping strategies to help reduce the burden of living with the disease.

Explore Sanofi’s IBD Clinical Trials and Research

Sanofi brings extensive IBD clinical trial expertise to both Crohn’s disease and ulcerative colitis. Explore our ongoing clinical trials:

Ulcerative colitis & Crohn’s disease clinical trials

References

  1. 1. McDowell C, Farooq U, Muhammad Haseeb. Inflammatory Bowel Disease. Nih.gov. Published August 4, 2023. https://www.ncbi.nlm.nih.gov/books/NBK470312/

    2. Wang R, Li Z, Liu S, Zhang D. Global, regional and national burden of inflammatory bowel disease in 204 countries and territories from 1990 to 2019: a systematic analysis based on the Global Burden of Disease Study 2019. BMJ Open. 2023;13(3):e065186. doi:10.1136/bmjopen-2022-065186

    ‌3. Liverani E. How to predict clinical relapse in inflammatory bowel disease patients. World Journal of Gastroenterology. 2016;22(3):1017-1017. doi:https://doi.org/10.3748/wjg.v22.i3.1017

    ‌4. Chen J, Vitetta L. Butyrate in Inflammatory Bowel Disease Therapy. Gastroenterology. 2020;158(5):1511-1511. doi:https://doi.org/10.1053/j.gastro.2019.08.064

    5. Ma C, Solitano V, Danese S, Jairath V. The Future of Clinical Trials in Inflammatory Bowel Disease. Clinical Gastroenterology and Hepatology. 2025;23(3):480-489. doi:https://doi.org/10.1016/j.cgh.2024.06.036

    ‌6. Understanding Diagnostic Delays in Crohn’s and Colitis: An Evidence Review for Crohn’s and Colitis UK.; 2022. https://crohnsandcolitis.org.uk/media/n3udnuct/understanding-diagnostic-delays-in-crohns-and-colitis-final-report-22-03-22-1.pdf

    7. Umar N, Harvey, P, Adderley, NJ, Haroon, S, Trudgill, N, et al. The Time to Inflammatory Bowel Disease Diagnosis for Patients Presenting with Abdominal Symptoms in Primary Care and its Association with Emergency Hospital Admissions and Surgery: A Retrospective Cohort Study. Inflamm Bowel Dis. 2025;31:140-150. https://doi.org/10.1093/ibd/izae057

    8. Allocca M, Fiorino G, Bonifacio C, Peyrin-Biroulet L, Danese S. Noninvasive Multimodal Methods to Differentiate Inflamed vs Fibrotic Strictures in Patients With Crohn’s Disease. Clinical Gastroenterology and Hepatology. 2019;17(12):2397-2415. doi:https://doi.org/10.1016/j.cgh.2019.04.025

    9. Shi HY, Ng SC. The state of the art on treatment of Crohn’s disease. Journal of Gastroenterology. 2018;53(9):989-998. doi:https://doi.org/10.1007/s00535-018-1479-6

    10. Kobayashi T, Mizuno N, Sato N, et al. Patient preferences for advanced therapies in ulcerative colitis using conjoint analysis. Intestinal Research. 2024;23(3):318-337. doi:https://doi.org/10.5217/ir.2024.00101

    ‌11. Mukhtar MS, Mosli MH. Selecting first-line advanced therapy for ulcerative colitis: A clinical application of personalized medicine. Saudi Journal of Gastroenterology. 2024;30(3):126-137. doi:https://doi.org/10.4103/sjg.sjg_427_23

    12. Allegretti JR, Bordeianou LG, Damas OM, et al. Challenges in IBD Research 2024: Pragmatic Clinical Research. Inflammatory Bowel Diseases. 2024;30(Supplement_2):S55-S66. doi:https://doi.org/10.1093/ibd/izae083

    ‌13. PREVENTION TYPES OF CLINICAL TRIALS. Accessed July 16, 2025. https://www.crohnscolitisfoundation.org/sites/default/files/2020-02/05-17-448-CC-IG-Types-of-CT.pdf

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