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Ability to provide informed consent |
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Aged 18 to 80 years of age |
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Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening |
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Evidence of UC extending proximal to the rectum (≥ 15 cm of involved colon) |
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Moderately to severely active UC as defined by |
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Average daily mMS Stool Frequency subscore ≥ 1 AND Average daily mMS Rectal Bleeding subscore ≥ 1 |
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Modified Mayo endoscopic subscore of ≥ 2 based on a full colonoscopy within 14 days prior to randomization |
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Participant had an inadequate response or intolerance to intervention with |
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conventional treatment or prior biological treatment or demonstrated CS |
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Participants taking 5-aminosalicylates, oral prednisone (or equivalent), oral budesonide, or immunomodulators must be at a stable dose or discontinued. Topical (rectal) aminosalicylic acid or topical (rectal) steroids should be discontinued |
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dependence for the treatment of UC. For participants who have previously used |
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Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal |
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biological treatment, a participant may have failed up to 3 biologics that |
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Non sterilized males who are sexually active with a female partner of childbearing potential should use condoms during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks |
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include up to 2 different mechanisms of action |
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Complete inclusion criteria are in the Clinical Study Protocol |
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Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control throughout the study and for at least 18 weeks after the last dose of study intervention |
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No known history of active TB or latent TB without completion of appropriate intervention and negative QFT-TB during Screening |
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Clinically significant cardiovascular conditions
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Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge)
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Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening are excluded
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History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months
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Participant has received the following treatment
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Infliximab: within 8 weeks prior to randomization
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Adalimumab, certolizumab pegol, or golimumab: within 8 weeks prior to randomization
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Vedolizumab or ustekinumab within 12 weeks of randomization
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Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to randomization
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Fecal microbiota transplantation: within 8 weeks prior to randomization
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Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23
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Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy
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Participant received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening
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Participants who received IV or intramuscular steroids within 2 weeks prior to Screening
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Criterion deleted as part of Amendment 5 v6.0
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Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study(s), or receiving other investigational agent(s)
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Participant received a transfusion of blood, plasma, or platelets within 30 days prior to Screening
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Participant has any of the following criteria related to infections
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Evidence of a recent systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment
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Any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of Screening
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Participant received a Bacille Calmette-Guérin vaccination within 12 months of randomization or any other live vaccine less than 4 weeks prior to randomization
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Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening
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Clinically significant chronic infection that has not resolved within 8 weeks of Screening
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Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with study medical monitor
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Clinical evidence of or suspected to have an abscess during Screening
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Any underlying condition that predisposes the participant to infections
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Participant had previous allogenic bone marrow transplant or history of organ or cell-based transplantation
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Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy
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Signs or symptoms of ongoing infection due to intestinal pathogens
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History of cancer with the following exceptions: history of basal cell carcinoma and/or squamous cell carcinoma of the skin OR carcinoma in situ of the cervix; with apparent successful curative therapy, greater than 12 months prior to Screening
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Prolonged QTcF interval or conditions leading to additional risk for QT prolongation
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Clinically significant kidney disease
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Participant has known or suspected history of chronic use of NSAIDs and/or opiates
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Abnormal laboratory results at Screening as defined in the study protocol
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drug, or alcohol abuse
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Participant is pregnant or breastfeeding or plans to become pregnant during the study
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Participant has other known, pre-existing, clinically significant medical conditions that are not associated with UC and are uncontrolled with standard treatment
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Participant has any disorder that may compromise the ability of the participant to give written informed consent and/or to comply with all required study procedures
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Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
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Complete exclusion criteria are in the Clinical Study Protocol
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