A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis

Protagonist Therapeutics, Inc0 个研究点目标入组 169 人开始时间: 2020年4月27日最近更新: 2022年8月8日

试验速览

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•1. Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
•2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
•3. Diagnosis of UC for = 8 weeks prior to screening supported by appropriate documentation of biopsy results consistent with UC, in the opinion of the investigator; if UC has been present for > 10 years, a total colonoscopy with biopsy must have been performed within 2 years of screening to rule out dysplasia. Subjects must be up-to date on colorectal cancer surveillance per local standards and guidelines. The colorectal cancer screening may be performed during screening colonoscopy.
•4. Moderate to severe active UC
•5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic.
•See protocol for further inclusion criteria
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 152
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 17

•1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
•4. History of colonic dysplasia (other than completely removed low-grade dysplastic lesion.
•5. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/antiinfectives within 2 weeks of screening.
•6. Positive stool test for C. difficile
•7. Chronic recurrent or serious infection.
•9. Known primary or secondary immunodeficiency.
•13. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
•18. History of any major neurological disorders.
•See protocol for further exclusion criteria

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