TAK-279-IBD-2001

Internal Medicine Gastroenterology Digestive Disease Adult Subjects

Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation.

This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461) and TAK-279-UC-2001 (NCT06254950). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study.

The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD.

The participants will be treated with TAK-279 for up to 2 years (108 weeks).

During the study, participants will visit their study clinic 11 times.

A PHASE 2/3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ORAL OZANIMOD (RPC1063) IN PEDIATRIC SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WITH AN INADEQUATE R…

Pediatrics Gastroenterology Digestive Disease Pediatric Subjects

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.