A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis

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• 1. Subjects with indeterminate/unclassified inflammatory bowel disease, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of CD.
• 18. Other infectious diseases: a. Subject has history of symptoms suggestive of systemic or invasive infection within 30 days before the first administration of study drug. b. Subject has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks before the first administration of study drug or oral antimicrobial therapy within 30 days before the first administration of study drug. c. Subject has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis). d. Subject has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days before the first administration of study drug. e. Subject has a history of opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis). f. Subjects with active enteric infections (positive stool culture and sensitivity), intestinal pathogens, Clostridioides difficile infection, or pseudomembranous colitis (subjects with infection at screening may be allowed retest after treatment) within 4 weeks before the first administration of study drug. g. Subject has active cytomegalovirus colitis requiring treatment in last 2 weeks before the first administration of study drug.
• 19. Noninfectious disorders: Subject has any clinically significant medical condition, evidence of an unstable clinical condition (eg, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. These include but are not limited to: a. Subject has a known or suspected history of a condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency or splenectomy. b. Subject had a major surgery within 60 days before the first administration of study drug or has a major surgery planned during the study. c. Subject has uncontrolled hypertension characterized by systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg at screening, confirmed by 2 separate visits. d. Subject has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria. e. Subject has a history of cancer or lymphoproliferative disease within 5 years before the first administration of study drug. Note: Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded on the basis of this exclusion criterion. f. For subjects with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, subject has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroid treatment, or has required more than 1 course of oral corticosteroids within 6 months before the first administration of study drug. g. Subject has any of the following cardiovascular history or unstable cardiovascular disease: A. A new diagnosis of atrial fibrillation, or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia), non-acute cardiac hospitalization (eg, pacemaker implantation) pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. B. Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery within the past 6 months prior to screening. h. Subject has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the subject if he or she participated in the study, in the opinion of the investigator. i. Subject has history of any significant/uncontrolled psychiatric illness (including but not limited to active suicidal ideation at screening or before the first administration of study drug) for which participation in the trial would, in the opinion of the investigator, put the subject at undue risk or would interfere with interpretation of study results. j. Subject has a known history of clinically significant drug or alcohol abuse within 12 months prior to the first administration of study drug as determined by the investigator.
• 2. Subjects with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study, could preclude the use of the modified Mayo score to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with TAK-279.
• 20. Subject has inadequate renal or hepatic function before randomization based on the following parameters: a. Total bilirubin (unconjugated and/or conjugated) ≥1.5 × upper limit of normal (ULN) unless the subject has known Gilbert’s syndrome that can explain the elevation of bilirubin, or b. Serum ALT or AST ≥3 × ULN, or c. Creatinine >1.5 × ULN. Note: The subjects may be retested (1 time) to meet eligibility criteria at the discretion of the investigator. d. d. Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation.
• 21. Subject with any of the following laboratory values at the screening visit: a. Hemoglobin <9.0 g/Dl (<90.0 g/L). b. Absolute white blood cell count <3.0 × 109 /L (<3000/mm3 ). c. Absolute neutrophil count of <1.2 × 109 /L (<1200/mm3 ). d. Absolute lymphocyte count of <0.75 × 109 /L (<750/mm3 ). e. Platelet count <100 × 109 /L. f. g. Thyroid-stimulating hormone (TSH) outside the normal reference range and free T4 (thyroxine) or T3 (triiodothyronine) outside the normal reference range. h. Any other significant laboratory abnormalities that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. i. CPK > ULN. CPK may be repeated once; if repeat value is CTCAE Grade 1 or lower (or ≤2.5 × ULN) and no higher than the initial value, subject remains eligible. Investigators should assess the subject for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.