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A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)
The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.
This is a Phase 2a, double-blind, placebo-controlled, parallel group study in subjects with active ulcerative colitis and a non-remission (partial) response to infliximab. All enrolled subjects must have been on infliximab for a minimum of 14 weeks with last dose 8 weeks prior to the date of randomization. Subjects will be randomly assigned to 1 of 2 treatment arms (PF-06687234 or placebo) administered subcutaneously every week for a total of 12 doses. Blood, stool and tissue samples will be collected at various time points throughout the study to evaluate efficacy, safety, tolerability, pharmacokinetics and immunogenicity. Duration of participation for subjects will be approximately 6 months.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Dothan Surgery Center
Dothan, Alabama, United States
Gut PC, dba Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Emory Investigational Drug Services
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
East Valley Endoscopy
Grand Rapids, Michigan, United States
Start Date
December 20, 2017
Primary Completion Date
January 7, 2021
Completion Date
January 7, 2021
Last Updated
December 28, 2021
20
ACTUAL participants
PF-06687234
DRUG
Placebo
DRUG
Lead Sponsor
Pfizer
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009