Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis
3 other identifiers
interventional
84
11 countries
76
Brief Summary
This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2011
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
November 18, 2014
CompletedNovember 18, 2014
November 1, 2014
2.1 years
January 25, 2011
November 10, 2014
November 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fold Change From Baseline in Fecal Calprotectin at Week 14
The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.
Baseline, Week 14
Secondary Outcomes (12)
Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab
Pre-dose to end of the dosing interval after Day 1, Week 12
Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab
Pre-dose to end of the dosing interval after Day 1, Week 12
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab
Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2
Plasma Decay Half-Life (t1/2) for Anrukinzumab
Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Systemic Clearance (CL) for Anrukinzumab
Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
- +7 more secondary outcomes
Other Outcomes (5)
Clinical Response Rate at Week 14
Week 14
Clinical Remission Rate at Week 14
Week 14
Change From Baseline in Total Mayo Score at Week 14
Baseline, Week 14
- +2 more other outcomes
Study Arms (4)
Arm 1
EXPERIMENTAL200 mg PF-05230917, Anrukinzumab active dose level
Arm 2
EXPERIMENTAL400 mg PF-05230917, Anrukinzumab active dose level
Arm 3
EXPERIMENTAL600 mg PF-05230917, Anrukinzumab active dose level
Arm 4
PLACEBO COMPARATORMatching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
Interventions
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Eligibility Criteria
You may qualify if:
- Male or Female, Age \>=18 and \<=65 years
- Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score
- women of childbearing potential with highly effective method of contraception
You may not qualify if:
- Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (76)
The Kirkland Clinic
Birmingham, Alabama, 35233, United States
UAB Hospital
Birmingham, Alabama, 35233, United States
UAB Hospital Department of Pharmacy
Birmingham, Alabama, 35249, United States
Administrative Offices
Birmingham, Alabama, 35294, United States
UAB ACIP
Birmingham, Alabama, 35294, United States
Arizona Surgical Center
Phoenix, Arizona, 85006, United States
Dedicated Phase I, Inc.
Phoenix, Arizona, 85013, United States
AGMG Endoscopy Center
Anaheim, California, 92801, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
West Coast Radiology Center
Santa Ana, California, 92705, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, 06518, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
International Clinical Research - US, LLC
Sanford, Florida, 32771, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
GI Diagnostics
Marietta, Georgia, 30067, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202, United States
Gastrointestional Associates, PA
Jackson, Mississippi, 39202, United States
St. Dominic Hospital
Jackson, Mississippi, 39216, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Piedmont Gastroenterology Specialists
Winston-Salem, North Carolina, 27103, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease
Cleveland, Ohio, 44106, United States
Wheeler and Stuckey, Inc.
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
OU Physicians Building
Oklahoma City, Oklahoma, 73104, United States
Memphis Gastroenterology Group, PC
Germantown, Tennessee, 38138, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Centennial Medical Center Physicians Park
Nashville, Tennessee, 37203, United States
Centennial Medical Center Tower Medical Imaging
Nashville, Tennessee, 37203, United States
Columbia Medical Group - The First Clinic Inc.
Nashville, Tennessee, 37203, United States
Radiology Alliance
Nashville, Tennessee, 37203, United States
Professional Quality Research, Inc.
Austin, Texas, 78705, United States
Austin Endoscopy Center
Austin, Texas, 78757, United States
Austin Gastroenterology, PA
Austin, Texas, 78757, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Austin Gastroenterology, PA
Round Rocks, Texas, 78681, United States
Cardiology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229, United States
San Antonio Endoscopy Center
San Antonio, Texas, 78229, United States
CNS Pharmacy
Murray, Utah, 84123, United States
RGL Medical Services
Salt Lake City, Utah, 84084, United States
Alpine Medical Group
Salt Lake City, Utah, 84102, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Wasatch Endoscopy Center
Salt Lake City, Utah, 84124, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Krankenhaus der Elisabethinen Linz GmbH
Linz, 4020, Austria
Landesklinikum St. Poelten
Sankt Pölten, 3100, Austria
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, 1090, Austria
MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie
Rousse, 7002, Bulgaria
MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia
Sofia, 1606, Bulgaria
DKTs Sveta Anna, Gastroenterologichen cabinet
Sofia, 1750, Bulgaria
Heritage Medical Research Clinic - University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Vancouver Coastal Health - Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver General Hospital - The Gordon and Leslie Diamond Centre
Vancouver, British Columbia, V5Z 1M9, Canada
The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston
Kingston, Ontario, K7L 5G2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
CHU Hopital Nord
Amiens, 80054, France
Hopital Beaujon
Clichy, 92110, France
CHU Hotel-Dieu
Nantes, 44093, France
Charite - Campus Berlin Mitte
Berlin, 10117, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, 1136, Hungary
Clinfan Kft.
Szekszárd, 7100, Hungary
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology
Amsterdam, 1105 AZ, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX, Netherlands
Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii
Warsaw, 02-507, Poland
Sectia Clinica Medicina Interna II
Bucharest, 010816, Romania
Hospital Clinic I Provincial de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007, Spain
Related Publications (1)
Reinisch W, Panes J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F. Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study. Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7.
PMID: 25567115DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 26, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 18, 2014
Results First Posted
November 18, 2014
Record last verified: 2014-11