CT-P13 SC is a medication administered through a subcutaneous injection. It is being studied to see how well it works and how safe it is for patients with active Crohn’s Disease or Ulcerative Colitis. The goal is to determine if this form of the medication is as effective as the intravenous version in terms of how the body absorbs and processes it.

CT-P13 IV is the intravenous form of the same medication, used as a comparison in the study. It is already known for its use in treating Crohn’s Disease and Ulcerative Colitis, and the study aims to compare its effectiveness and safety with the subcutaneous version.

Crohn’s Disease – A chronic inflammatory condition of the gastrointestinal tract, Crohn’s disease can affect any part from the mouth to the anus, but most commonly impacts the end of the small intestine and the beginning of the colon. The inflammation can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The disease often progresses with periods of flare-ups and remission, where symptoms may subside or disappear. Over time, the inflammation can cause complications like strictures or fistulas. The exact cause is unknown, but it involves an abnormal immune response to intestinal bacteria in genetically susceptible individuals.

Ulcerative Colitis – This is a chronic inflammatory condition that specifically affects the colon and rectum. The inflammation is usually limited to the innermost lining of the colon and rectum, leading to symptoms such as persistent diarrhea, abdominal pain, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. It progresses with alternating periods of exacerbation and remission. The cause is not fully understood, but it is believed to involve an inappropriate immune response to the gut flora in genetically predisposed individuals.