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Pfizer's ulcerative colitis pill study halted early

NCT ID NCT05549323

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental oral drug, PF-07054894, in adults aged 18-75 with mild to severe ulcerative colitis (UC). The goal was to see if the drug could safely help control the disease and reduce symptoms like diarrhea and rectal bleeding. The trial was terminated early, so results are limited. It was a Phase 1 study with 44 participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

44 people

The number who actually took part.

Started

Nov 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • Carta - Clinical Associates In Research Therapeutics Of America

    San Antonio, Texas, 78212, United States

  • Centrum Medyczne Med-Gastr

    Lodz, 91-034, Poland

  • Charité Research Organisation

    Berlin, 10117, Germany

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117, Germany

  • GCP Clinical Research

    Tampa, Florida, 33609, United States

  • IHS Health Research

    Kissimmee, Florida, 34741, United States

  • IRMED

    Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland

  • KLIMED Marek Klimkiewicz

    Bialystok, Podlaskie Voivodeship, 15-704, Poland

  • Kissimmee Endosocpy Center ( Endoscopy Only )

    Kissimmee, Florida, 34741, United States

  • MZ Badania Slowik Zymla Spolka Jawna

    Knurów, Silesian Voivodeship, 44-190, Poland

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231, Poland

  • NZOZ Twoje Zdrowie EL Sp. z o. o.

    Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

  • Orlando Diagnostic Center ( CXR Only )

    Kissimmee, Florida, 34741, United States

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-688, Poland

  • Tampa Bay Endoscopy Center

    Tampa, Florida, 33603, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.