PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
NCT ID: NCT04504383
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
169 participants
INTERVENTIONAL
2020-08-05
2023-02-16
Brief Summary
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Detailed Description
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Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PN-943 450 mg BID
Oral administration of PN-943 450 mg BID
PN-943
Administered by the oral route BID for the duration of the study.
PN-943 150 mg BID
Oral administration of PN-943 150 mg BID
PN-943
Administered by the oral route BID for the duration of the study.
Placebo BID
Oral administration of matching placebo
Placebo
Administered by the oral route BID for 12 weeks.
Interventions
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PN-943
Administered by the oral route BID for the duration of the study.
Placebo
Administered by the oral route BID for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
3. Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
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 (excluding vedolizumab).
Exclusion Criteria
2. History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
3. 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.
4. Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
5. Positive stool test for C. difficile.
6. Chronic recurrent or serious infection.
7. Known primary or secondary immunodeficiency.
8. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
9. History of any major neurological disorders.
18 Years
75 Years
ALL
No
Sponsors
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Protagonist Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Protagonist Investigational Site
Tucson, Arizona, United States
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Garden Grove, California, United States
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Los Angeles, California, United States
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Murrieta, California, United States
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San Francisco, California, United States
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Colorado Springs, Colorado, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Saint Augustine, Florida, United States
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Wesley Chapel, Florida, United States
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Metairie, Louisiana, United States
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Glen Burnie, Maryland, United States
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Chesterfield, Michigan, United States
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Troy, Michigan, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Englewood, New Jersey, United States
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North Massapequa, New York, United States
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Charlotte, North Carolina, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Orangeburg, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Garland, Texas, United States
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Pasadena, Texas, United States
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Spring, Texas, United States
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Lynchburg, Virginia, United States
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Innsbruck, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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West Vancouver, British Columbia, Canada
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North Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Vaughan, Ontario, Canada
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Berlin, , Germany
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Berlin, , Germany
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Kiel, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Székesfehérvár, , Hungary
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Castellana Grotte, , Italy
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Modena, , Italy
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Negrar, , Italy
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Padua, , Italy
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Roma, , Italy
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Roma, , Italy
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San Giovanni Rotondo, , Italy
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Poznan, Greater Poland Voivodeship, Poland
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Bydgoszcz, , Poland
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Bydgoszcz, , Poland
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Częstochowa, , Poland
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Częstochowa, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Ksawerów, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Nowy Targ, , Poland
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Piotrkow Trybunalski, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Sopot, , Poland
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Swidnica, , Poland
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Torun, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Włocławek, , Poland
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Chelyabinsk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Perm, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Saratov, , Russia
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Stavropol, , Russia
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Tomsk, , Russia
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Tyumen, , Russia
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Zrenjanin, , Serbia
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Busan, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Ivano-Frankivsk, , Ukraine
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Kherson, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Zhytomyr, , Ukraine
Countries
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Other Identifiers
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PN-943-03
Identifier Type: -
Identifier Source: org_study_id
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