Ulcerative ColitisPhase 1NCT05549323
A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
A Phase 1 study testing PF-07054894 in people with Ulcerative Colitis, run by Pfizer at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- PF-07054894
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 7 Nov 2022to 11 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Poland8 sites
KLIMED Marek Klimkiewicz
Bialystok, Podlaskie Voivodeship, 15-704
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231
NZOZ Twoje Zdrowie EL Sp. z o. o.
Elblag, Warmian-Masurian Voivodeship, 82-300
MZ Badania Slowik Zymla Spolka Jawna
Knurów, Silesian Voivodeship, 44-190
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 30-688
Centrum Medyczne Med-Gastr
Lodz, 91-034
IRMED
Piotrkow Trybunalski, Łódź Voivodeship, 97-300
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, 04-501
United States7 sites
University of Iowa
Iowa City, Iowa, 52242
IHS Health Research
Kissimmee, Florida, 34741
Kissimmee Endosocpy Center ( Endoscopy Only )
Kissimmee, Florida, 34741
Orlando Diagnostic Center ( CXR Only )
Kissimmee, Florida, 34741
Carta - Clinical Associates In Research Therapeutics Of America
San Antonio, Texas, 78212
Tampa Bay Endoscopy Center
Tampa, Florida, 33603
GCP Clinical Research
Tampa, Florida, 33609
Germany2 sites
Charité Research Organisation
Berlin, 10117
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
About this study
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
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.
- Conditions
- Ulcerative Colitis
- Being tested
- PF-07054894, Placebo
- Keywords
- Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07054894Drug
Oral
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Oral PF-07054894 Receives: Drug: PF-07054894 |
| Treatment Group 2 | Placebo comparator | Matched Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.
Measured: Week 12
Secondary outcomes (3)
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)
Measured: 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
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start7 Nov 2022
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of the two groups in parallel for the duration of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549323
- Sponsor's protocol ID
- C4151002
- Other IDs
- 2022-501047-32-00
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05549323
- Acronym / sponsor ID
- C4151002
- Conditions
- Ulcerative Colitis
- Keywords
- Inflammatory Bowel Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of the two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: PF-07054894Oral PF-07054894 |
| Treatment Group 2 | Placebo comparator | Drug: PlaceboMatched Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07054894Oral | Drug | Treatment Group 1 |
| PlaceboPlacebo | Drug | Treatment Group 2 |
Primary outcome
Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.
Time frame: Week 12
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
Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.
Time frame: Week 12
3 secondary outcomes
Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12
Time frame: Week 12
Part A: Proportion of participants with clinical remission at Week 12
Time frame: Week 12
Part B: Proportion of participants achieving clinical remission at Week 12
Time frame: Week 12
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07054894 in people with Ulcerative Colitis, run by Pfizer at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Poland, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC. (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.