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Driving Innovation in Inflammatory Bowel Disease Research

Gilead is committed to delivering transformative inflammatory bowel disease (IBD) therapies to improve the lives of patients for years to come. Through clinical research, we are developing and enhancing new treatments to help patients affected by the disease.

Inflammatory Bowel Disease

IBD involves long-term inflammation in your digestive system. About 1 out of 100 Americans are diagnosed with IBD each year. The 2 most common types of IBD are ulcerative colitis and Crohn’s disease.

Sources: Centers for Disease Control and Prevention, Crohn’s & Colitis Foundation

What is ulcerative colitis?

Ulcerative colitis is a long-term condition that involves inflammation in the innermost layer of the lining of the colon (the longest part of the large intestine). It typically starts with small sores or ulcers in the rectum, which spread upwards through the colon. Symptoms may include diarrhea, bloody stools, abdominal cramping, and weight loss.

Most people are diagnosed with ulcerative colitis in their mid-30s. It occurs in men and women equally, and affects people of any racial or ethnic group.

The exact cause of ulcerative colitis remains unclear. However, it does tend to occur more often in people who have a family history of inflammatory bowel disease.

Sources: Centers for Disease Control and Prevention, Crohn’s & Colitis Foundation, Crohn’s & Colitis Foundation, Crohn’s & Colitis Foundation

How is ulcerative colitis treated?

Ulcerative colitis is commonly treated with medications that can decrease inflammation, such as mesalamine or corticosteroids.

Moderate to severe cases that require long-term treatment are typically treated with immunosuppressants or biologics. These treatments are frequently administered through an IV or injection. However, some people may prefer the convenience of an oral treatment.

Source: National Institute of Diabetes and Digestive and Kidney Diseases

In the United States, approximately

1.3 million people

have ulcerative colitis

Source: Lewis JD et al, 2023

Ulcerative colitis trials currently recruiting patients

STATUS Recruiting

PALEKONA

A phase 2 clinical trial evaluating the efficacy and safety of GS-5290 in people with moderate to severe ulcerative colitis.
STATUS Recruiting

SWIFT

A phase 2 clinical trial evaluating the efficacy and safety of GS-1427 in people with moderate to severe ulcerative colitis.
See if you qualify OR Call 1-833-GIL-EAD 6

What is Crohn’s disease?

Crohn’s disease is a long-term condition that also involves inflammation, but it can affect any part of the gastrointestinal tract. It most commonly impacts the small intestine, and often spreads into the deeper layers of the intestinal lining. Symptoms may include abdominal pain, persistent diarrhea, fatigue, weight loss, and loss of appetite.

Crohn’s disease can happen at any age but usually starts when people are between 15 and 35 years old. It affects men and women equally and people from all ethnic backgrounds.

The cause of Crohn’s disease is not fully understood. But hereditary, genetic, and environmental factors may play a role, according to recent research.

Sources: Centers for Disease Control and Prevention, Crohn’s & Colitis Foundation, Crohn’s & Colitis Foundation, Crohn’s & Colitis Foundation

Want to learn more about clinical trials?

Diversity in Our Clinical Trials

Understanding Clinical Trials

Your Questions Answered

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

YOUR QUESTIONS ANSWERED

FAQ Topic:
ALL Clinical Trial Basics Safety and Security Trial Terms Defined The Clinical Trial

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

All trials have different timelines due to various factors, such as the trial phase, study design, treatment duration or health condition being studied. During the consent process before enrolling, the research team will explain the specifics about the trial.
Due to the many differences in insurance plans across the country, coverage in clinical trials can vary. You will learn more about your options during pre-screening.
If you are living with a medical condition, joining a clinical trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future. Healthy volunteers in trials contribute to this medical progress as well by helping understand the effect of the potential treatment and any safety concerns.
As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.
Yes, participants are volunteers and may withdraw from a clinical trial at any time.
A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and research team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if no approved intervention is available.
"Standard of care" is an intervention already approved for a specific health condition that is available publicly. Interventions in a clinical trial are still being tested to ensure safety and effectiveness.
Some clinical trials are designed to be "double blind" so both participants and researchers are unaware of which treatment group participants are assigned to. This prevents bias from affecting clinical trial data.
Your informed consent is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.
Under FDA regulations, an Institutional Review Board (IRB) is a group that has been formally designated to review and monitor research at a hospital or institution involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research.
Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.
After your participation ends, the study may continue for months or years. Once final results from all participants are compiled and analyzed, they are often published publicly. Clinical study report (CSR) synopses and plain language summaries (PLSs) may be made available for certain studies. Check with your clinical trial site or send an email to [email protected] to learn more.
There are a wide variety of professionals involved with any clinical trial, all of whom are vital to ensuring safety and success. The principal investigator, or PI, leads the trial and directs the team of doctors, nurses and other healthcare workers. The clinical trial coordinator manages day-to-day activities and is the main contact for participants. Many clinical trials also have an independent Data and Safety Monitoring Board (DSMB) who periodically reviews data to ensure participant safety, and sometimes effectiveness.
If you don’t qualify because you don’t meet the trial criteria, consider discussing other options with your healthcare provider or the patient’s physician would need to submit a managed access request based on the eligibility. Click here to learn more.