A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis

Key facts

Study ID

NCT04209556

Run by

Pfizer

People needed

0

Starts

2020-09-30

Expected to finish

2023-10-26

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with moderate to severe UC as defined by a total Mayo score of ≥6, with a rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2;
• 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).

You may not qualify if…

• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or Crohn's disease
• Participants displaying clinical signs of fulminant colitis or toxic megacolon;
• Participants with evidence of colonic dysplasia, adenomas or neoplasia.

Where it is running

• 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

Full record on ClinicalTrials.gov

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