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What’s Happening in Ulcerative Colitis Trials Right Now?

By Renee Butler
On January 18, 2021

Ulcerative Colitis, or UC, is a chronic condition that is characterized by inflammation of the colon. Most people with UC will begin to develop symptoms around ages 15-30, but there is no guarantee. Some will not develop the condition until later in life. The condition is difficult to diagnose because Ulcerative Colitis often manifests in alternating periods of flares and remissions. What we do know is that there is a hereditary component. The likelihood of developing UC is around 4-16% higher amongst first-degree relatives. It also appears more frequently In certain ethnic groups, particularly Caucasians and amongst Jewish populations. In North America, there are around 750,000 people with UC, or roughly 240 people in 100,000.

 

Understanding Ulcerative Colitis

A type of inflammatory bowel disease, there is no cure and no definitive cause for Ulcerative Colitis. It is suspected that UC is an autoimmune condition in which the body attacks the intestinal lining and/or necessary bacteria within the gastrointestinal system, but there is no absolute answer. In turn, there are varying opinions and strategies as to how UC can be managed or treated. There are several standard of care (SOC) protocols. Which one a patient receives depends on the severity of UC symptoms and whether or not the person is in remission.

 

UC Standard of Care

Treating Ulcerative Colitis is centered around three basic components: Medication, Nutrition, and Surgery. For the majority of UC sufferers, medication and nutrition are enough to live comfortable lives. Approximately 25-33% of Ulcerative Colitis patients will require surgery at some point in their lives. Should this happen, the colon is often removed and replaced with an ileostomy.

Nutrition-wise, UC patients are generally advised to avoid foods that are difficult to process, such as spicy foods or foods that are high in fiber. Instead, they are encouraged to eat softer foods that have good nutritional value. Medications, on the other hand, are more about managing symptoms than avoiding them. For instance, these therapeutics may serve to prevent diarrhea or reduce abdominal pain if that is a symptom. Initial UC treatments may even be a topical medication delivered as a suppository or enema. More severe cases of Ulcerative Colitis tend to involve sulfasalazine or mesalazine, but oral steroids are also used frequently. If remission is achieved, immunosuppressants are often employed.

 

Trials in Progress

As of August 2020, there are 270 UC studies that are in the Open or Planned phases. There are 175 Open studies and 95 Planned studies. Looking at Open studies, there are 57 Phase II studies and 33 Phase III ones. A similar pattern is reflected in Planned studies. According to Citeline, there are 39 Phase II UC trials in the works and 13 Phase III studies. The primary mechanisms of action include immunosuppressants as well as Interleukin 23 antagonist, Alpha4beta7 integrin antagonist, Cyclooxygenase inhibitor, Integrin antagonist, and Janus kinase 1 inhibitor.

 

Studying Ulcerative Colitis

Pharm-Olam has provided clinical research services for 53 studies within this therapeutic area, including five Phase II studies focused on UC. Our team knows gastroenterology and autoimmune. In fact, two of our medical monitors specialize in UC specifically while 84% of Pharm-Olam PMs have worked on autoimmune studies and 87% of company CRAs are experienced in autoimmune research. This bank of experience allows Pharm-Olam to be responsive and proactive.

With that in mind, we recently published a white paper that examines the competitive landscape as it relates to UC. Download your copy here or click the image below:

UC_Landscape_WhitePaper_COVER

 

Tags: Autoimmune, CRO Services

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