A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
NCT ID: NCT04209556
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2020-09-30
2023-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Matched Placebo
PF-06826647 100 mg once a day (QD)
PF-06826647 100 mg once a day (QD)
PF-06826647 100 mg QD
Investigational Product
PF-06826647 300 mg QD
PF-06826647 300 mg QD
PF-06826647 300 mg QD
Investigational Product
PF-06826647 600 mg QD
PF-06826647 600 mg QD
PF-06826647 600 mg QD
Investigational Product
Open Label Extension, PF-06826647 400 mg QD
PF-06826647 400 mg QD
PF-6826647 400 mg QD
Investigational Product
Interventions
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PF-06826647 100 mg QD
Investigational Product
PF-06826647 300 mg QD
Investigational Product
PF-06826647 600 mg QD
Investigational Product
Placebo
Matched Placebo
PF-6826647 400 mg QD
Investigational Product
Eligibility Criteria
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Inclusion Criteria
* Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC: Oral, intravascular, or intramuscular corticosteroids; Immunosuppressants (azathioprine \[AZA\], 6-MP, or methotrexate \[MTX\]); Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg, tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).
Exclusion Criteria
* Participants displaying clinical signs of fulminant colitis or toxic megacolon;
* Participants with evidence of colonic dysplasia, adenomas or neoplasia.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hope Clinical Research
Canoga Park, California, United States
ADVA Clinical Research
Inglewood, California, United States
Centinela Valley Endoscopy Center
Inglewood, California, United States
Inglewood Imaging Center
Inglewood, California, United States
Surinder Saini, M.D., Inc.
Newport Beach, California, United States
Renaissance Imaging Center (CT/Xray)
Northridge, California, United States
Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)
Tarzana, California, United States
Saludmax Medical Corp.
Miami, Florida, United States
Alliance Clinical Research of Tampa
Tampa, Florida, United States
Gastroenterology Consultants P.C.
Roswell, Georgia, United States
Internal Medicine Associates (c/o TrialSpark, Inc.)
Merrillville, Indiana, United States
Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)
Clifton, New Jersey, United States
Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center
Houston, Texas, United States
Houston Digestive Diseases Consultants, P.A.
Houston, Texas, United States
Memorial Hermann SW Surgery Center
Houston, Texas, United States
Gastroenterology Consultants of San Antonio
San Antonio, Texas, United States
Victorium Clinical Research
San Antonio, Texas, United States
South Texas Radiology Imaging Center
San Antonio, Texas, United States
Sugar Lakes Family Practice, PA
Sugar Land, Texas, United States
Gastroenterolgy Associates of Northern Virginia
Fairfax, Virginia, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States
Verity Research, Inc.
Fairfax, Virginia, United States
Fair Oaks Imaging Center- Reston Radiology Consultants
Fairfax, Virginia, United States
Associates in Gastroenterology (c/o TrialSpark, inc)
Woodbridge, Virginia, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2019-003999-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C2501003
Identifier Type: -
Identifier Source: org_study_id