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
- Conditions
- Moderate to Severely Active Ulcerative ColitisMedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-506769-67-00
- Lead Sponsor
- Takeda Development Center Americas Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 207
The subject is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator. The subject has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures., Subjects must be aged =18 and =75 years at the time of the signing of the ICF., Subjects must have moderately to severely active UC at screening as defined by: a. A modified Mayo score of 5 to 9 points, with b. An endoscopic subscore of =2., Subjects must have a documented diagnosis (endoscopic with histology) of UC for at least 30 days before screening with disease extending >15 cm from the anal verge. Documented diagnosis is defined as: a. A biopsy report to confirm the histological diagnosis AND b. A report documenting disease duration based upon prior colonoscopy. Note: If a biopsy report is not available in the source document at the time of screening, a local histology report of a biopsy performed during the screening colonoscopy should be consistent with a UC diagnosis. If the histology diagnosis is not consistent with UC at this time point, the subject will not be eligible for inclusion., Subjects with extensive colitis or pancolitis of >8 years’ duration or left-sided colitis >12 years’ duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (if not performed in the previous 12 months, it must be performed during screening)., Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up to date on colorectal cancer surveillance (may be performed during screening)., Subjects must be willing and able to undergo colonoscopy with biopsies during screening after all other inclusion criteria have been met., Subjects with history of inadequate response to, loss of response to, or intolerance to one or more of these therapies for UC based on Physician assessment (according to either [a] or [b] below or a combination of both): a) 6-mercaptopurine or azathioprine, oral or IV corticosteroids, or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC symptoms). AND/OR b) Biologic agents (such as TNF antagonists, antibodies to IL-23p19, IL-12/23p40, vedolizumab) or any advanced therapy (such as a4 integrin antagonists, JAKi, or S1P receptor modulators). • Inadequate response: The subject experiences continued disease activity despite treatment with an adequate therapeutic dose and treatment course (dictated by the product label and UC therapeutic guidelines as per the study site region). • Loss of response: The subject experiences relapse after an initial clinical response or remission. • Intolerance: The subject has a history of having experienced an unacceptable or dose-limiting toxicity associated with the use of the agent., Subjects agree to comply with the contraceptive requirements of the protocol, or female subjects of nonchildbearing potential. Female subjects of reproductive potential who are sexually active must agree to use appropriate contraception for the duration of the study and 10 days after the last dose of the study drug. The following birth control requirements must be met: a)b) Female subjects must be surgically sterile; be of nonchildbearing potential with labo
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 nailbed mycosis). 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 withi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of TAK-279 orally administered, compared with placebo, in achieving clinical remission at Week 12 in subjects with moderately to severely active ulcerative colitis.;Secondary Objective: To evaluate the efficacy of TAK-279, compared to placebo, in achieving clinical response, symptomatic remission, and endoscopic changes at Week 12 in subjects with moderately to severely active UC., To evaluate the effect of TAK-279 on patient reported symptoms of UC in subjects with moderately to severely active UC., To evaluate the effect of TAK-279 on disease-specific health-related quality of life (HRQoL) in subjects with moderately to severely active UC.;Primary end point(s): Clinical remission at Week 12, assessed as the proportion of subjects achieving a modified Mayo score of =2 with stool frequency subscore of =1, rectal bleeding subscore of 0, and centrally read endoscopic subscore of =1 (score of 1 modified to exclude friability).
- Secondary Outcome Measures
Name Time Method