Lutikizumab for Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Gastroenterology
Sandra Park
A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis

Study Description

Eligibility

Participant has had a diagnosis of Ulcerative Colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available.

Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review).

Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies.

Current diagnosis of Crohn's Disease (CD) or inflammatory bowel disease-unclassified.

Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.

Prior exposure to adalimumab (including biosimilars). Note: Subject may be enrolled if he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.

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