Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.
NCT ID: NCT03269695
Last Updated: 2021-12-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2017-12-20
2021-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PF-06687234
PF-06687234 subcutaneous (SC) weekly (QW) x 12 doses
PF-06687234
SC QW
Placebo
PF-06687234 matched Placebo SC QW x 12 doses
Placebo
SC QW
Interventions
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PF-06687234
SC QW
Placebo
SC QW
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of active UC (histologic) for 4 months.
* Subjects with active UC as defined by (via screening endoscopy) a total Mayo Score of 4 or more but 9 or less and an endoscopic subscore of 2.or more.
* UC extending at least 15 cm proximal to the anal verge at the time of the screening endoscopy.
* Must be on a stable dose 5-10 mg/kg of Remicade, Inflectra, or Remsima for a minimum of 14 weeks with no anticipation of need for change in infliximab treatment regimen throughout the study
* Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use two methods of contraception (at least one of which is considered as highly effective) throughout the study and until the Week 16 visit
Exclusion Criteria
* Subjects need for surgery or with major elective surgery scheduled during the study.
* Subjects with extensive colitis for at least 8 years who have not had a colonoscopy with surveillance biopsies within 2 years prior to baseline.
* Subjects with history of or at screening endoscopy, biopsy documented colonic dysplasia or neoplasia.
* Subjects who require infliximab dosing interval other than every 6 weeks or every 8 weeks.
* Subjects displaying clinical signs of fulminant colitis or toxic megacolon, with primary sclerosing cholangitis, known colonic stricture, history of colonic, small bowel obstruction or resection, with history of or current colonic or small bowel stoma.
* Cyclic neutropenia, thrombocytopenia, lymphopenia, leukopenia or history of chronic anemia.
* Presence of active enteric infection.
* Known history of human immunodeficiency virus (HIV) based on documented history with positive serological test, or positive HIV serologic test.
* Presence of transplanted organ.
* Anticipated need for any live vaccine.
* Class III or Class IV heart failure.
* Acute coronary syndrome and any history of cerebrovascular disease.
* Subjects with current, or a history of QT prolongation.
* Subjects receiving the following therapies within the designated time period:
* \>9 mg/day of oral budesonide or \>20 mg/day of prednisone or equivalent within 2 weeks prior to baseline.
* IV, IM or topical (rectal) treatment of 5-ASA or corticosteroid enemas within 2 weeks prior to baseline.
* Anti integrin inhibitors within 14 weeks prior to baseline.
* Any use of natalizumab.
* Interferon therapy within 8 weeks prior to baseline.
* Prior treatment with lymphocyte depleting therapies and alkylating agents.
* Received selective B lymphocyte depleting agents within 1 year prior to baseline.
* Receiving leukocyte apheresis, granulocyte apheresis, or plasma exchange within 6 months of baseline.
* JAK inhibitors within 3 months prior to baseline.
* Any investigational procedures(s) or product(s)30 days prior to baseline.
* History of sensitivity to heparin or heparin induced thrombocytopenia
* Known history of hypersensitivity, intolerance, or allergic reaction to PF-06687234 or any constituent of the IP.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Eastside Endoscopy Center
Macomb, Michigan, United States
Eastside Endoscopy Center
Saint Clair Shores, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, Australia
St. Vincent's Hospital, Melbourne
Fitzroy, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
St John Of God Health Care Inc. Trading as St. John of God Subiaco Hospital
Subiaco, Western Australia, Australia
CHC Montlegia
Liège, , Belgium
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, , Germany
The Chaim Sheba Medical Center
Ramat Gan, , Israel
ASST Rhodense - Ospedale di Circolo di Rho
Rho, Milano, Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
King Abdulaziz University Hospital
Jeddah, , Saudi Arabia
King Abdullah International Medical Research Center
Riyadh, , Saudi Arabia
King Khalid University Hospital
Riyadh, , Saudi Arabia
CHC "Dr Dragisa Misovic-Dedinje"
Belgrade, , Serbia
Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology
Belgrade, , Serbia
The Catholic University of Korea, St. Vincent's Hospital
Gyeonggi-do, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2017-002108-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BUILD UC
Identifier Type: OTHER
Identifier Source: secondary_id
B7581002
Identifier Type: -
Identifier Source: org_study_id