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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: PF-06826647 100 mg QD; Drug: PF-06826647 300 mg QD; Drug: PF-06826647 600 mg QD; Drug: PF-6826647 400 mg QD

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matched Placebo
Experimental: PF-06826647 100 mg once a day (QD)	Drug: PF-06826647 100 mg QD; Investigational Product
Experimental: PF-06826647 300 mg QD	Drug: PF-06826647 300 mg QD; Investigational Product
Experimental: PF-06826647 600 mg QD	Drug: PF-06826647 600 mg QD; Investigational Product
Experimental: Open Label Extension, PF-06826647 400 mg QD; PF-06826647 400 mg QD	Drug: PF-6826647 400 mg QD; Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving endoscopic response	Endoscopic response is defined by Mayo endoscopic index < 2	At Week 8
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)		At Week 60
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
Percentage of participants with clinically significant changes in Electrocardiogram (ECG)	Clinical significant changes in ECG	At Week 60
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of participants achieving endoscopic remission	Endoscopic remission is defined as Mayo endoscopic index of 0	At Week 8 and 60
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
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
Mean change from baseline in partial Mayo score over time		Up to 60 weeks
Change from baseline in total Mayo score		At Week 8 and 60
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)		At Week 8
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2020
• Primary Completion (Anticipated): October 26, 2023
• Study Completion (Anticipated): October 26, 2023

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: C2501003; 2019-003999-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No