Status:
COMPLETED
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
Lead Sponsor:
Protagonist Therapeutics, Inc.
Conditions:
Ulcerative Colitis Chronic Moderate
Ulcerative Colitis Chronic Severe
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily \[BID\] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate...
Detailed Description
The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID. P...
Eligibility Criteria
Inclusion
- Key
- Male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
- Moderate to severe active UC.
- Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab).
- Key
Exclusion
- Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
- History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
- 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/anti-infectives within 2 weeks of screening.
- Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
- Positive stool test for C. difficile.
- Chronic recurrent or serious infection.
- Known primary or secondary immunodeficiency.
- Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
- History of any major neurological disorders.
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04504383
Start Date
August 5 2020
End Date
February 16 2023
Last Update
April 25 2023
Active Locations (122)
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1
Protagonist Investigational Site
Tucson, Arizona, United States, 85712
2
Protagonist Investigational Site
Garden Grove, California, United States, 92845
3
Protagonist Investigational Site
Los Angeles, California, United States, 90036
4
Protagonist Investigational Site
Murrieta, California, United States, 92563