Clinical trial NCT05549323: A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of the two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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).

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 or considered in imminent need of surgery or with elective surgery scheduled to occur during the study.
* Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
* Clinically significant infections within 6 months of baseline

Primary outcomes:
measure: Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.
timeFrame: Week 12
measure: Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.
timeFrame: Week 12
Secondary outcomes:
measure: Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12
timeFrame: Week 12
measure: Part A: Proportion of participants with clinical remission at Week 12
timeFrame: Week 12
measure: Part B: Proportion of participants achieving clinical remission at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Kissimmee
country: United States
facility: IHS Health Research
state: Florida
city: Kissimmee
country: United States
facility: Kissimmee Endosocpy Center ( Endoscopy Only )
state: Florida
city: Kissimmee
country: United States
facility: Orlando Diagnostic Center ( CXR Only )
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: San Antonio
country: United States
facility: Carta - Clinical Associates In Research Therapeutics Of America
state: Texas
city: Berlin
country: Germany
facility: Charité Research Organisation
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: Endoterapia PFG SP. Z O. O.
state: Mazowieckie
city: Warsaw
country: Poland
facility: Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
state: Mazowieckie
city: Kraków
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
state: Małopolskie
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
state: Podlaskie
city: Elblag
country: Poland
facility: NZOZ Twoje Zdrowie EL Sp. z o. o.
state: Warmińsko-mazurskie
city: Lodz
country: Poland
facility: Centrum Medyczne Med-Gastr
city: Piotrkow Trybunalski
country: Poland
facility: IRMED
state: Łódzkie
city: Knurów
country: Poland
facility: MZ Badania Slowik Zymla Spolka Jawna
state: Śląskie
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: