Back to resultsA Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-07054894
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Inflammatory Bowel Disease
Eligibility 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
Sites / Locations
- IHS Health ResearchRecruiting
- Kissimmee Endosocpy Center ( Endoscopy Only )Recruiting
- Orlando Diagnostic Center ( CXR Only )Recruiting
- University of Miami Hospital -Procedures
- University of Miami Hospitals and Clinics Crohn's and Colitis Center
- GCP Clinical ResearchRecruiting
- University of IowaRecruiting
- Charter RadiologyRecruiting
- Cascades Endoscopy CenterRecruiting
- Gastro Center of Maryland, LLCRecruiting
- Carta - Clinical Associates In Research Therapeutics Of AmericaRecruiting
- Universitaetsklinikum Ulm
- Universitätsklinikum Ulm
- Charité Research OrganisationRecruiting
- Charité Universitaetsmedizin Berlin - Campus MitteRecruiting
- NZOZ Centrum Medyczne KERmedRecruiting
- WIP Warsaw IBD Point Profesor KierkuśRecruiting
- Endoterapia PFG SP. Z O. O.Recruiting
- KLIMED Marek KlimkiewiczRecruiting
- KLIMED Marek Klimkiewicz
- NZOZ Twoje Zdrowie EL Sp. z o. o.Recruiting
- Centrum Medyczne Med-GastrRecruiting
- H-T Centrum Medyczne Endoterapia
- IRMED
- MZ Badania Slowik Zymla Spolka JawnaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group 1
Treatment Group 2
Arm Description
Oral PF-07054894
Matched Placebo
Outcomes
Primary Outcome Measures
Proportion of participants achieving clinical remission at 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
Proportion of participants achieving improvement in endoscopic appearance at Week 12
Endoscopic improvement is defined as a Mayo endoscopic subscore of ≤1 (without friability)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05549323
Brief Title
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, 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
October 22, 2024 (Anticipated)
Study Completion Date
October 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of the two groups in parallel for the duration of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
Oral PF-07054894
Arm Title
Treatment Group 2
Arm Type
Placebo Comparator
Arm Description
Matched Placebo
Intervention Type
Drug
Intervention Name(s)
PF-07054894
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Proportion of participants achieving clinical remission at Week 12
Description
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
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of participants achieving improvement in endoscopic appearance at Week 12
Description
Endoscopic improvement is defined as a Mayo endoscopic subscore of ≤1 (without friability)
Time Frame
Week 12
Title
Proportion of participants with clinical remission at Week 12
Description
Clinical Remission defined by Total Mayo Score ≤2 and no individual subscore >1 and rectal bleeding subscore of 0
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
IHS Health Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Kissimmee Endosocpy Center ( Endoscopy Only )
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Diagnostic Center ( CXR Only )
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Hospital -Procedures
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Miami Hospitals and Clinics Crohn's and Colitis Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GCP Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Charter Radiology
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Name
Cascades Endoscopy Center
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastro Center of Maryland, LLC
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Individual Site Status
Recruiting
Facility Name
Carta - Clinical Associates In Research Therapeutics Of America
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden-württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Charité Research Organisation
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité Universitaetsmedizin Berlin - Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
NZOZ Centrum Medyczne KERmed
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-231
Country
Poland
Individual Site Status
Recruiting
Facility Name
WIP Warsaw IBD Point Profesor Kierkuś
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Recruiting
Facility Name
Endoterapia PFG SP. Z O. O.
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Individual Site Status
Recruiting
Facility Name
KLIMED Marek Klimkiewicz
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-704
Country
Poland
Individual Site Status
Recruiting
Facility Name
KLIMED Marek Klimkiewicz
City
Łomża
State/Province
Podlaskie
ZIP/Postal Code
18-404
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
NZOZ Twoje Zdrowie EL Sp. z o. o.
City
Elblag
State/Province
Warmińsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Med-Gastr
City
Lodz
ZIP/Postal Code
91-034
Country
Poland
Individual Site Status
Recruiting
Facility Name
H-T Centrum Medyczne Endoterapia
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
IRMED
City
Piotrkow Trybunalski
State/Province
Łódzkie
ZIP/Postal Code
97-300
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
MZ Badania Slowik Zymla Spolka Jawna
City
Knurów
State/Province
Śląskie
ZIP/Postal Code
44-190
Country
Poland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4151002
Description
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Learn more about this trial
A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
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