A PHASE 1B, TWO-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MILD TO SEVERE ULCERATIVE COLITIS
Status: Active_not_recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UC for ≥3 months prior to baseline.
• Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the 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 least one conventional therapy for UC.
• Total body weight \>40 kg (88.2 lb).
Locations
United States
Florida
IHS Health Research
Kissimmee
Kissimmee Endosocpy Center ( Endoscopy Only )
Kissimmee
Orlando Diagnostic Center ( CXR Only )
Kissimmee
GCP Clinical Research
Tampa
Tampa Bay Endoscopy Center
Tampa
Iowa
University of Iowa
Iowa City
Texas
Carta - Clinical Associates In Research Therapeutics Of America
San Antonio
Other Locations
Germany
Charité Research Organisation
Berlin
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin
Poland
KLIMED Marek Klimkiewicz
Bialystok
NZOZ Centrum Medyczne KERmed
Bydgoszcz
NZOZ Twoje Zdrowie EL Sp. z o. o.
Elblag
MZ Badania Slowik Zymla Spolka Jawna
Knurów
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow
Centrum Medyczne Med-Gastr
Lodz
IRMED
Piotrkow Trybunalski
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś