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

Ulcerative Colitis Clinical Trial

Official title:

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04209556
• Other study ID #: C2501003
• Secondary ID: 2019-003999-39
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 30, 2020
• Est. completion date: October 26, 2023

Study information

• Verified date: December 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Hope Clinical Research	Canoga Park	California
United States	Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)	Clifton	New Jersey
United States	Fair Oaks Imaging Center- Reston Radiology Consultants	Fairfax	Virginia
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	Houston Digestive Diseases Consultants, P.A.	Houston	Texas
United States	Memorial Hermann SW Surgery Center	Houston	Texas
United States	Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center	Houston	Texas
United States	ADVA Clinical Research	Inglewood	California
United States	Centinela Valley Endoscopy Center	Inglewood	California
United States	Inglewood Imaging Center	Inglewood	California
United States	Internal Medicine Associates (c/o TrialSpark, Inc.)	Merrillville	Indiana
United States	Saludmax Medical Corp.	Miami	Florida
United States	Surinder Saini, M.D., Inc.	Newport Beach	California
United States	Renaissance Imaging Center (CT/Xray)	Northridge	California
United States	Gastroenterology Consultants P.C.	Roswell	Georgia
United States	Gastroenterology Consultants of San Antonio	San Antonio	Texas
United States	South Texas Radiology Imaging Center	San Antonio	Texas
United States	Victorium Clinical Research	San Antonio	Texas
United States	Sugar Lakes Family Practice, PA	Sugar Land	Texas
United States	Alliance Clinical Research of Tampa	Tampa	Florida
United States	Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)	Tarzana	California
United States	Associates in Gastroenterology (c/o TrialSpark, inc)	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving endoscopic response	Endoscopic response is defined by Mayo endoscopic index < 2	At Week 8
Primary	Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)		At Week 60
Primary	Number of Participants With Clinical Laboratory Abnormalities	Following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).	At Week 60
Primary	Percentage of participants with clinically significant changes in Electrocardiogram (ECG)	Clinical significant changes in ECG	At Week 60
Primary	Number of Participants With Categorical changes from baseline in Vital Signs Data	Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 60.	At Week 60
Secondary	Percentage of participants achieving clinical remission	Clinical remission is defined by total Mayo score of = 2 with no individual subscore of > 1	At Week 8 and 60
Secondary	Percentage of participants achieving endoscopic remission	Endoscopic remission is defined as Mayo endoscopic index of 0	At Week 8 and 60
Secondary	Percentage of participants achieving mucosal healing	Mucosal healing is defined as both total Mayo score and histologic index of = 1.	At Week 8 and 60
Secondary	Percentage of participants achieving clinical response	Clinical response is defined as a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one point decrease or absolute score of 0 or 1 in rectal bleeding subscore.	At Week 8 and 60
Secondary	Mean change from baseline in partial Mayo score over time		Up to 60 weeks
Secondary	Change from baseline in total Mayo score		At Week 8 and 60
Secondary	Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)		At Week 8
Secondary	Number of Participants With Clinical Laboratory Abnormalities	Following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).	At Week 8
Secondary	Percentage of participants with clinically significant changes in Electrocardiogram (ECG)	Clinically significant changes from baseline in ECG (heart rate, QT, QTc, PR and QRS intervals)	At Week 8
Secondary	Number of Participants With Categorical Vital Signs Data	Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 8.	At Week 8

External Links

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