Phase
Condition
Crohn's Disease
Inflammatory Bowel Disease
Colic
Treatment
PF-07054894
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UCfor ≥3 months prior to baseline.
Active disease beyond the rectum (>15 cm of active disease from the anal verge atthe screening endoscopy).
Part A (moderate to severe): Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2. Part B (mild to moderate): Participants with mMS of 4 to 6, ES of ≥2 and RB score of ≥1
Must have inadequate response to, loss of response to, or intolerance to at leastone conventional therapy for UC.
Total body weight >40 kg (88.2 lb).
Exclusion
Exclusion Criteria:
Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis;diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/resection; presence of cancer.
History of bowel surgery within 6 months prior to baseline.
History of significant trauma or major surgery within 4 weeks of screening orconsidered in imminent need of surgery or with elective surgery scheduled to occurduring the study.
Presence of clinical signs of fulminant colitis or toxic megacolon, primarysclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
Clinically significant infections within 6 months of baseline
Study Design
Connect with a study center
Universitaetsklinikum Ulm
Ulm, Baden-württemberg 89081
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, Baden-württemberg 89081
GermanySite Not Available
Charité Research Organisation
Berlin, 10117
GermanyActive - Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
GermanyActive - Recruiting
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Kujawsko-pomorskie 85-231
PolandSite Not Available
Endoterapia PFG SP. Z O. O.
Warsaw, Mazowieckie 02-665
PolandActive - Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Mazowieckie 04-501
PolandActive - Recruiting
Medical Network WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Mazowieckie 04-501
PolandSite Not Available
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Mazowieckie 04-501
PolandActive - Recruiting
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Mazowieckie 00-728
PolandActive - Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Kraków, Małopolskie 30-688
PolandActive - Recruiting
KLIMED Marek Klimkiewicz
Bialystok, Podlaskie 15-704
PolandActive - Recruiting
KLIMED Marek Klimkiewicz
Łomża, Podlaskie 18-404
PolandSite Not Available
NZOZ Twoje Zdrowie EL Sp. z o. o.
Elblag, Warmińsko-mazurskie 82-300
PolandSite Not Available
IRMED
Piotrkow Trybunalski, Łódzkie 97-300
PolandActive - Recruiting
MZ Badania Slowik Zymla Spolka Jawna
Knurów, Śląskie 44-190
PolandSite Not Available
H-T Centrum Medyczne Endoterapia
Tychy, Śląskie 43-100
PolandSite Not Available
Centrum Medyczne Med-Gastr
Lodz, 91-034
PolandSite Not Available
H-T Centrum Medyczne
Tychy, 43-100
PolandSite Not Available
IHS Health Research
Kissimmee, Florida 34741
United StatesSite Not Available
Kissimmee Endosocpy Center ( Endoscopy Only )
Kissimmee, Florida 34741
United StatesSite Not Available
Orlando Diagnostic Center ( CXR Only )
Kissimmee, Florida 34741
United StatesSite Not Available
University of Miami Hospital -Procedures
Miami, Florida 33136
United StatesSite Not Available
University of Miami Hospitals and Clinics Crohn's and Colitis Center
Miami, Florida 33136
United StatesSite Not Available
GCP Clinical Research
Tampa, Florida 33609
United StatesActive - Recruiting
University of Iowa
Iowa City, Iowa 52242
United StatesActive - Recruiting
Cascades Endoscopy Center
Columbia, Maryland 21045
United StatesActive - Recruiting
Charter Radiology
Columbia, Maryland 21044
United StatesActive - Recruiting
Gastro Center of Maryland, LLC
Columbia, Maryland 21045
United StatesSite Not Available
Carta - Clinical Associates In Research Therapeutics Of America
San Antonio, Texas 78212
United StatesSite Not Available
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