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

December 15, 2020 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving endoscopic response
Time Frame: At Week 8
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)
Time Frame: At Week 60
At Week 60
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: At Week 60
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)
Time Frame: At Week 60
Clinical significant changes in ECG
At Week 60
Number of Participants With Categorical changes from baseline in Vital Signs Data
Time Frame: At Week 60
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving clinical remission
Time Frame: At Week 8 and 60
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
Time Frame: At Week 8 and 60
Endoscopic remission is defined as Mayo endoscopic index of 0
At Week 8 and 60
Percentage of participants achieving mucosal healing
Time Frame: At Week 8 and 60
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
Time Frame: At Week 8 and 60
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
Time Frame: Up to 60 weeks
Up to 60 weeks
Change from baseline in total Mayo score
Time Frame: At Week 8 and 60
At Week 8 and 60
Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)
Time Frame: At Week 8
At Week 8
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: At Week 8
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)
Time Frame: At Week 8
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
Time Frame: At Week 8
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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