A Study to Learn About the Safety, Effects and Pharmacoki... | NCT05549323

ID	Type	Description	Link
2022-501047-32-00	Registry Identifier	CTIS (EU)

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated due to business decision. The decision to terminate the trial was not based on any safety concerns associated with PF-07054894.

Expanded Access Info

Start Date

Nov 7, 2022Actual

Primary Completion Date

Nov 11, 2025Actual

Completion Date

Nov 11, 2025Actual

First Submitted Date

Sep 17, 2022

First Submission Date that Met QC Criteria

Sep 17, 2022

First Posted Date

Sep 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group 1	Experimental	Oral PF-07054894	Drug: PF-07054894
Treatment Group 2	Placebo Comparator	Matched Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-07054894	Drug	Oral	Treatment Group 1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Week 12
Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.		Week 12

Secondary Outcomes

Measure	Description	Time Frame
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)	Week 12
Part A: Proportion of participants with clinical remission at Week 12

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
IHS Health Research		Kissimmee	Florida	34741	United States
Kissimmee Endosocpy Center ( Endoscopy Only )

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases