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

Primary Purpose

Ulcerative Colitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-06826647 100 mg QD
PF-06826647 300 mg QD
PF-06826647 600 mg QD
Placebo
PF-6826647 400 mg QD
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hope Clinical Research
  • ADVA Clinical Research
  • Centinela Valley Endoscopy Center
  • Inglewood Imaging Center
  • Surinder Saini, M.D., Inc.
  • Renaissance Imaging Center (CT/Xray)
  • Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)
  • Saludmax Medical Corp.
  • Alliance Clinical Research of Tampa
  • Gastroenterology Consultants P.C.
  • Internal Medicine Associates (c/o TrialSpark, Inc.)
  • Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)
  • Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center
  • Houston Digestive Diseases Consultants, P.A.
  • Memorial Hermann SW Surgery Center
  • Gastroenterology Consultants of San Antonio
  • Victorium Clinical Research
  • South Texas Radiology Imaging Center
  • Sugar Lakes Family Practice, PA
  • Gastroenterolgy Associates of Northern Virginia
  • Gastroenterology Associates of Northern Virginia
  • Verity Research, Inc.
  • Fair Oaks Imaging Center- Reston Radiology Consultants
  • Associates in Gastroenterology (c/o TrialSpark, inc)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

PF-06826647 100 mg once a day (QD)

PF-06826647 300 mg QD

PF-06826647 600 mg QD

Open Label Extension, PF-06826647 400 mg QD

Arm Description

Placebo

PF-06826647 100 mg once a day (QD)

PF-06826647 300 mg QD

PF-06826647 600 mg QD

PF-06826647 400 mg QD

Outcomes

Primary Outcome Measures

Percentage of participants achieving endoscopic response
Endoscopic response is defined by Mayo endoscopic index < 2
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
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]).
Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
Clinical significant changes in ECG
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.

Secondary Outcome Measures

Percentage of participants achieving clinical remission
Clinical remission is defined by total Mayo score of ≤ 2 with no individual subscore of > 1
Percentage of participants achieving endoscopic remission
Endoscopic remission is defined as Mayo endoscopic index of 0
Percentage of participants achieving mucosal healing
Mucosal healing is defined as both total Mayo score and histologic index of ≤ 1.
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.
Mean change from baseline in partial Mayo score over time
Change from baseline in total Mayo score
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
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]).
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)
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.

Full Information

First Posted
December 1, 2019
Last Updated
December 15, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04209556
Brief Title
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study was withdrawn following a strategic portfolio re-prioritization.
Study Start Date
September 30, 2020 (Anticipated)
Primary Completion Date
October 26, 2023 (Anticipated)
Study Completion Date
October 26, 2023 (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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
PF-06826647 100 mg once a day (QD)
Arm Type
Experimental
Arm Description
PF-06826647 100 mg once a day (QD)
Arm Title
PF-06826647 300 mg QD
Arm Type
Experimental
Arm Description
PF-06826647 300 mg QD
Arm Title
PF-06826647 600 mg QD
Arm Type
Experimental
Arm Description
PF-06826647 600 mg QD
Arm Title
Open Label Extension, PF-06826647 400 mg QD
Arm Type
Experimental
Arm Description
PF-06826647 400 mg QD
Intervention Type
Drug
Intervention Name(s)
PF-06826647 100 mg QD
Intervention Description
Investigational Product
Intervention Type
Drug
Intervention Name(s)
PF-06826647 300 mg QD
Intervention Description
Investigational Product
Intervention Type
Drug
Intervention Name(s)
PF-06826647 600 mg QD
Intervention Description
Investigational Product
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched Placebo
Intervention Type
Drug
Intervention Name(s)
PF-6826647 400 mg QD
Intervention Description
Investigational Product
Primary Outcome Measure Information:
Title
Percentage of participants achieving endoscopic response
Description
Endoscopic response is defined by Mayo endoscopic index < 2
Time Frame
At Week 8
Title
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
Time Frame
At Week 60
Title
Number of Participants With Clinical Laboratory Abnormalities
Description
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]).
Time Frame
At Week 60
Title
Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
Description
Clinical significant changes in ECG
Time Frame
At Week 60
Title
Number of Participants With Categorical changes from baseline in Vital Signs Data
Description
Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 60.
Time Frame
At Week 60
Secondary Outcome Measure Information:
Title
Percentage of participants achieving clinical remission
Description
Clinical remission is defined by total Mayo score of ≤ 2 with no individual subscore of > 1
Time Frame
At Week 8 and 60
Title
Percentage of participants achieving endoscopic remission
Description
Endoscopic remission is defined as Mayo endoscopic index of 0
Time Frame
At Week 8 and 60
Title
Percentage of participants achieving mucosal healing
Description
Mucosal healing is defined as both total Mayo score and histologic index of ≤ 1.
Time Frame
At Week 8 and 60
Title
Percentage of participants achieving clinical response
Description
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.
Time Frame
At Week 8 and 60
Title
Mean change from baseline in partial Mayo score over time
Time Frame
Up to 60 weeks
Title
Change from baseline in total Mayo score
Time Frame
At Week 8 and 60
Title
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
Time Frame
At Week 8
Title
Number of Participants With Clinical Laboratory Abnormalities
Description
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]).
Time Frame
At Week 8
Title
Percentage of participants with clinically significant changes in Electrocardiogram (ECG)
Description
Clinically significant changes from baseline in ECG (heart rate, QT, QTc, PR and QRS intervals)
Time Frame
At Week 8
Title
Number of Participants With Categorical Vital Signs Data
Description
Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 8.
Time Frame
At Week 8

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: 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.
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
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
ADVA Clinical Research
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Centinela Valley Endoscopy Center
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Inglewood Imaging Center
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Surinder Saini, M.D., Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Renaissance Imaging Center (CT/Xray)
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Saludmax Medical Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Alliance Clinical Research of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Gastroenterology Consultants P.C.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Internal Medicine Associates (c/o TrialSpark, Inc.)
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Houston Digestive Diseases Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Memorial Hermann SW Surgery Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Gastroenterology Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Victorium Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
South Texas Radiology Imaging Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Sugar Lakes Family Practice, PA
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Gastroenterolgy Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Gastroenterology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Verity Research, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Fair Oaks Imaging Center- Reston Radiology Consultants
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Associates in Gastroenterology (c/o TrialSpark, inc)
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22192
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C2501003
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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