A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.

Vital sign values include body temperature, respiratory rate, sitting blood pressure (systolic and diastolic, resting more than 5 minutes), pulse (beats per minute). Clinical significance of vital signs will be determined at the investigator's discretion.

Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion.

ECGs will be performed with the participant in the supine or semi-supine position and after resting comfortably for at least 5 minutes. Clinical significance of 12-lead ECG values will be determined at the investigator's discretion.

Clinical remission is defined as a CDAI score of less than (<) 150 points.

Clinical response is defined as greater than (>) 100-point decrease from parent study baseline in CDAI score.

Endoscopic response is defined by decrease in SES-CD >50 percent (%) from baseline (defined as % baseline in parent study TAK-279-CD-2001 [NCT06233461]) (or for participants with isolated ileal disease, SES-CD less than or equal to (=<) 4 or at least a 2-point reduction from baseline). The SES-CD score ranges from 0 to 56 which includes 4 endoscopic variables (intestinal surface affected by ulcers, intestinal surface affected by other inflammatory lesions, presence of ulcers, and presence of narrowing).

Endoscopic remission is defined as SES-CD score =< 4 or =< 2 for ileal disease, no sub-score >1. The SES-CD score ranges from 0 to 56 which includes 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).

Clinical remission based on PRO2 is defined as average daily liquid or very soft stool frequency (SF) score less than or equal to (<=) 2.8 and not worse than parent study baseline and average daily abdominal pain (AP) score <=1 and not worse than baseline.

Clinical response based on PRO2 is defined as greater than or equal to (>=) 30% decrease in average daily very soft or liquid stools and/ or >=30% decrease in average AP from parent study baseline.

The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component sub-score ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined as Mayo RB sub-score of 0, Mayo SF sub-score of 0 or 1, and ES sub-score 1 or 0 (score of 1 modified to exclude friability).

Clinical response is defined as reduction from parent study baseline in mMS of >=2 points and >=30% from parent study baseline and a decrease from parent study baseline in the RB sub-score of >=1 point or an absolute RB sub-score of <=1 point.

Symptomatic remission is defined as RB sub-score of 0 and SF sub-score of Mayo score <=1.

Endoscopic improvement is defined as a modified Mayo ES of <=1 (score of 1 modified to exclude friability).

Endoscopic remission is defined as a modified Mayo ES of 0.

Bowel urgency is measured by the bowel urgency electronic diary (eDiary) item.

Abdominal pain is measured by abdominal pain eDiary item.

The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.

The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel systems (10 items), emotional function (12 items), systemic function (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.

The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel systems (10 items), emotional functional (12 items), systemic function (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.