Phase
Condition
N/ATreatment
PRA023 IV
Companion diagnostic (CDx)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed diagnosis of Crohn's disease
Moderately to severely active CD as defined by Crohn's disease activity index (CDAI)score and centrally read endoscopy
Must have corticosteroid dependence or have had no response, insufficient response,loss of response and/or intolerance to at least one of the following therapies:corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF),anti-integrin, or anti-interleukin (IL)12/23
Able to provide written informed consent and understand and comply with therequirements of the study
Exclusion
Exclusion Criteria:
Women of child bearing potential (WOCBP) and men with female partner of childbearingpotential who are unwilling to use two highly effective methods of contraception toavoid pregnancy for the entire study period and up to 12 weeks after the last doseof study drug
Diagnosis of ulcerative colitis (UC) or indeterminate colitis
CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonicand/or illeal involvement
Suspected or diagnosed intra-abdominal or perianal abscess at screening
Current stoma or need for colostomy or ileostomy
Previous small bowel resection with a combined resected length of >100 cm orprevious colonic resection of > 2 segments
Surgical bowel resection within 3 months before screening
Past or current evidence of definite low-grade or high-grade colonic dysplasia notcompletely removed
Subjects in the opinion of the investigator are at an unacceptable risk forparticipation in the study
Subjects who meet the protocol criteria for important laboratory exclusion criteria
Study Design
Connect with a study center
Prometheus Biosciences Selected Site
Bankstown, New South Wales 2146
AustraliaSite Not Available
Prometheus Biosciences Selected Site
Old Toongabbie, New South Wales 2146
AustraliaSite Not Available
Prometheus Biosciences Selected Site
South Brisbane, Queensland 4101
AustraliaSite Not Available
Prometheus Biosciences Selected Site
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Prometheus Biosciences Selected Site
Adelaide, South Australia 5000
AustraliaSite Not Available
Prometheus Biosciences Selected Site
Leuven, 3000
BelgiumSite Not Available
Prometheus Biosciences Selected Site
Liège, 4000
BelgiumSite Not Available
Prometheus Biosciences Selected Site
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
Prometheus Biosciences Selected Site
London, Ontario N6A 5W9
CanadaSite Not Available
Prometheus Biosciences Selected Site
Brno,
CzechiaSite Not Available
Prometheus Biosciences Selected Site
Slaný, 274 01
CzechiaSite Not Available
Prometheus Biosciences Selected Site
Clichy, 92110
FranceSite Not Available
Prometheus Biosciences Selected Site
Nice, 06202
FranceSite Not Available
Prometheus Biosciences Selected Site
Saint-Priest-en-Jarez, 42270
FranceSite Not Available
Prometheus Biosciences Selected Site
Vandœuvre-lès-Nancy, 54511
FranceSite Not Available
Prometheus Biosciences Selected Site
Tbilisi,
GeorgiaSite Not Available
Prometheus Biosciences Selected Center
Kraków, 31-501
PolandSite Not Available
Prometheus Biosciences Selected Site
Rzeszów, 35-326
PolandSite Not Available
Prometheus Biosciences Selected Site
Sopot, 81-756
PolandSite Not Available
Prometheus Biosciences Selected Site
Toruń, 87-100
PolandSite Not Available
Prometheus Biosciences Selected Center
Warsaw, 00-635
PolandSite Not Available
Prometheus Biosciences Selected Site
Warsaw, 03-580
PolandSite Not Available
Prometheus Biosciences Selected Site
Wrocław, 52-416
PolandSite Not Available
Prometheus Biosciences Selected Site
Łódź, 93-357
PolandSite Not Available
Prometheus Biosciences Selected Site
Kyiv,
UkraineSite Not Available
Prometheus Biosciences Selected Site
Los Angeles, California 90045
United StatesSite Not Available
Prometheus Biosciences Selected Site
Liberty, Kansas 64098
United StatesSite Not Available
Prometheus Biosciences Selected Site
Chesterfield, Michigan 48047
United StatesSite Not Available
Prometheus Biosciences Selected Site
Ypsilanti, Michigan 48197
United StatesSite Not Available
Prometheus Biosciences Selected Site
Saint Louis, Missouri 63141
United StatesSite Not Available
Prometheus Biosciences Selected Site
Lebanon, New Hampshire 03756
United StatesSite Not Available
Prometheus Biosciences Selected Site
New York, New York 10065
United StatesSite Not Available
Prometheus Biosciences Selected Site
Garland, Texas 75044
United StatesSite Not Available
Prometheus Biosciences Selected Site
Lubbock, Texas 79410
United StatesSite Not Available
Prometheus Biosciences Selected Site
San Antonio, Texas 78229
United StatesSite Not Available
Prometheus Biosciences Selected Site
Southlake, Texas 78229
United StatesSite Not Available
Prometheus Biosciences Selected Site
Tyler, Texas 75702
United StatesSite Not Available
Prometheus Biosciences Selected Site
Bellevue, Washington 98004
United StatesSite Not Available
Prometheus Biosciences Selected Site
Tacoma, Washington 98405
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.