The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Ulcerative Colitis. The purpose of Cohort 2 of the study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active ulcerative colitis who are companion diagnostic positive. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for another 38 weeks.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04996797 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Prometheus Biosciences, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Prometheus Biosciences |
Principal Investigator Affiliation | Clinicaltrials Call center |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Belgium, Canada, Czechia, France, Georgia, Hungary, Israel, Italy, Poland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ulcerative Colitis |
Experimental: Cohort 1 PRA023
Participants randomized to receive PRA023 administered by intravenous (IV) infusion.
Placebo Comparator: Cohort 1 Placebo
Participant randomized to receive placebo administered by intravenous (IV) infusion.
Experimental: CDx+ Expansion Cohort PRA023
Participants randomized to receive PRA023 administered by intravenous (IV) infusion.
Placebo Comparator: CDx+ Expansion Cohort Placebo
Participant randomized to receive placebo administered by intravenous (IV) infusion.
Drug: - PRA023 IV
PRA023 administered by IV infusion
Device: - Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Other: - Placebo
Placebo administered by IV infusion
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
Prometheus Biosciences Selected Center
Mobile, Alabama, 36608
Status
Not yet recruiting
Address
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Phoenix, Arizona, 85006
Status
Not yet recruiting
Address
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Sun City, Arizona, 85351
Status
Recruiting
Address
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Los Angeles, California, 90045
Status
Recruiting
Address
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Los Angeles, California, 90048
Status
Recruiting
Address
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San Diego, California, 92037
Status
Recruiting
Address
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Bristol, Connecticut, 06010
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Address
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Atlanta, Georgia, 30010
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Not yet recruiting
Address
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Arlington Heights, Illinois, 60005
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Address
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Glenview, Illinois, 60026
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Address
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Gurnee, Illinois, 60031
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Address
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Kansas City, Kansas, 66160
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Recruiting
Address
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Liberty, Kansas, 64098
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Baton Rouge, Louisiana, 70809
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Recruiting
Address
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Recruiting
Address
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Recruiting
Address
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Lebanon, New Hampshire, 03756
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Recruiting
Address
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New York, New York, 10029
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Recruiting
Address
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New York, New York, 10065
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Address
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Recruiting
Address
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Germantown, Tennessee, 38138
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Recruiting
Address
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Bedford, Texas, 76022
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Recruiting
Address
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Lubbock, Texas, 79424
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Address
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Mansfield, Texas, 76063
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Recruiting
Address
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San Antonio, Texas, 78229
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Recruiting
Address
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Recruiting
Address
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Tyler, Texas, 75702
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Recruiting
Address
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Charlottesville, Virginia, 22903
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Recruiting
Address
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Tacoma, Washington, 98405
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Recruiting
Address
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Woodville, Adelaide,
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Recruiting
Address
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Kingswood, New South Wales, 2747
Status
Recruiting
Address
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Old Toongabbie, New South Wales, NSW 2146
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Address
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South Brisbane, Queensland, 4101
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Address
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Woolloongabba, Queensland, 4102
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Address
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Adelaide, South Australia, 5000
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Address
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Fitzroy, Victoria, VIC 3065
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Address
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Melbourne, Victoria, VIC 3065
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Address
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Leuven, , 3000
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Recruiting
Address
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Liège, , 4000
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Recruiting
Address
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Calgary, Alberta, T2N 4Z6
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Address
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Vancouver, British Columbia, V6Z2K5
Status
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Address
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Halifax, Nova Scotia, B3H 1V7
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Not yet recruiting
Address
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North York, Ontario, M6A 3B4
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Recruiting
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Brno, ,
Status
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Address
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Hradec Králové, ,
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Olomouc, , 779 00
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Slaný, ,
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Clichy, , 92110
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Recruiting
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Lille, , 59037
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Recruiting
Address
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Nice, , 06202
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Recruiting
Address
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Pierre-Bénite, , 69495
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Address
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Tbilisi, ,
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Bekescsaba, , 5600
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Budapest, , 1062
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Budapest, , 1088
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Afula, , 18341
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Be'er Sheva, , 84100
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Address
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Milano, Milan, 20132
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Address
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Milano, Milan, 20157
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Address
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Roma, Rome, 00168
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Address
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Poznań, Greater Poland, 61-441
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Address
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Wloclawek, Kuuavian-Pomeranian, 87-800
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Address
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Wrocław, Lower Silesian, 40-211
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Address
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Wrocław, Lower Silesian, 540144
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Address
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Warszawa, Masovia, 04-730
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Address
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Katowice, Silesian, 40-211
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Kraków, ,
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Lublin, , 20-362
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Lublin, , 20-607
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Rzeszów, ,
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Szczecin, ,
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Toruń, ,
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Warsaw, ,
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Warsaw, ,
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Wrocław, ,
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Łódź, , 93-357
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Recruiting
Address
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Prescot, Merseyside, L34 1BH
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Address
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London, , E11 1NR
Support the Crohn's
& Colitis Foundation
733 THIRD AVENUE, SUITE 510, NEW YORK, NY 10017
info@crohnscolitisfoundation.org
©COPYRIGHT 2022 CROHN'S & COLITIS FOUNDATION
The Crohn's & Colitis Foundation is a 501(c)(3) non-profit organization dedicated to finding cures for Crohn's disease and ulcerative colitis and improving the quality of life of children and adults affected by these diseases.
Crohn’s & Colitis Foundation es una organización sin fines de lucro 501(c)(3) dedicada a encontrar la cura de la enfermedad de Crohn y la colitis ulcerosa y a mejorar la calidad de vida de las personas afectadas por estas enfermedades.