This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.
Inclusion Criteria:
Exclusion Criteria:
Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis. Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture/stenosis within the small bowel or colon.
Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy.
Have a history of malignant neoplasm within the last 5 years.
Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
Have any active, chronic, or recurrent infections based on the investigator's assessment.
Have history of opportunistic infections within 1 year of screening
Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data.
Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening:
Have significant allergies to humanized monoclonal antibodies.
Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial.
Have ostomy or ileoanal pouch.
Have received any of the following for treatments of UC:
Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy.
Participant must not have signs of an ongoing infection related to an intestinal pathogen.
In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC.
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site;
Uncontrolled hypertension (i.e., blood pressure consistently measures >=140/90 millimeters of mercury (mmHg) while actively taking 1 or more antihypertensive medications).
GSKClinicalSupportHD@gsk.com
The study will be open label.
Participants will receive Aletekitug.
GSKClinicalSupportHD@gsk.com+44 (0) 20 89904466
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