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A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05549323
Recruitment Status : Recruiting
First Posted : September 22, 2022
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: PF-07054894 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of the two groups in parallel for the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 1B, 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 MODERATE TO SEVERE ULCERATIVE COLITIS
Actual Study Start Date : November 7, 2022
Estimated Primary Completion Date : October 22, 2024
Estimated Study Completion Date : October 22, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group 1
Oral PF-07054894
 Drug: PF-07054894
Oral
Placebo Comparator: Treatment Group 2
Matched Placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants achieving clinical remission at Week 12 [ 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


Secondary Outcome Measures :
  1. Proportion of participants achieving improvement in endoscopic appearance at Week 12 [ Time Frame: Week 12 ]
    Endoscopic improvement is defined as a Mayo endoscopic subscore of ≤1 (without friability)

  2. Proportion of participants with clinical remission at Week 12 [ Time Frame: Week 12 ]
    Clinical Remission defined by Total Mayo Score ≤2 and no individual subscore >1 and rectal bleeding subscore of 0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of moderate to severe 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).
  • Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2.
  • Must 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05549323


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Florida
IHS Health Research Recruiting
Kissimmee, Florida, United States, 34741
Kissimmee Endosocpy Center ( Endoscopy Only ) Recruiting
Kissimmee, Florida, United States, 34741
Orlando Diagnostic Center ( CXR Only ) Recruiting
Kissimmee, Florida, United States, 34741
GCP Clinical Research Recruiting
Tampa, Florida, United States, 33609
United States, Maryland
Charter Radiology Recruiting
Columbia, Maryland, United States, 21044
Cascades Endoscopy Center Recruiting
Columbia, Maryland, United States, 21045
Gastro Center of Maryland, LLC Recruiting
Columbia, Maryland, United States, 21045
United States, Texas
Carta - Clinical Associates In Research Therapeutics Of America Recruiting
San Antonio, Texas, United States, 78212
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05549323    
Other Study ID Numbers: C4151002
2022-501047-32-00 ( Registry Identifier: CTIS (EU) )
First Posted: September 22, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pfizer:
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases