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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Oral
Placebo
IHS Health Research
Kissimmee, Florida, United States
Kissimmee Endosocpy Center ( Endoscopy Only )
Kissimmee, Florida, United States
Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.
Clinical remission based on modified Mayo Score is defined as endoscopic subscore equal 0 or 1 (without friability), stool frequency subscore equal 0 or 1, and rectal bleeding subscore equal 0
Time frame: Week 12
Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.
Time frame: Week 12
Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12
Endoscopic improvement is defined as a Mayo endoscopic subscore of ≤1 (without friability)
Time frame: Week 12
Part A: Proportion of participants with clinical remission at Week 12
Clinical Remission defined by Total Mayo Score ≤2 and no individual subscore \>1 and rectal bleeding subscore of 0
Time frame: Week 12
Part B: Proportion of participants achieving clinical remission at Week 12
Clinical Remission based on modified Mayo Score is defined as endoscopic subscore 0 or 1 (without friability), stool frequency subscore 0 or 1, and rectal bleeding subscore 0.
Time frame: Week 12
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Orlando Diagnostic Center ( CXR Only )
Kissimmee, Florida, United States
Tampa Bay Endoscopy Center
Tampa, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Carta - Clinical Associates In Research Therapeutics Of America
San Antonio, Texas, United States
Charité Research Organisation
Berlin, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
...and 7 more locations