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Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anrukinzumab
Anrukinzumab
Anrukinzumab
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Active Ulcerative Colitis, Phase 2A, Double-blind, Randomized, PK/PD Biomarker Study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Kirkland Clinic
  • UAB Hospital
  • UAB Hospital Department of Pharmacy
  • Administrative Offices
  • UAB ACIP
  • Arizona Surgical Center
  • Dedicated Phase I, Inc.
  • AGMG Endoscopy Center
  • Anaheim Clinical Trials, LLC
  • West Coast Radiology Center
  • Endoscopy Center of Connecticut, LLC
  • Gastroenterology Center of Connecticut, PC
  • Medical Research Center of Connecticut, LLC
  • International Clinical Research - US, LLC
  • Gastrointestinal Specialists of Georgia, PC
  • GI Diagnostics
  • Gastrointestinal Associates, PA
  • Gastrointestional Associates, PA
  • St. Dominic Hospital
  • Digestive Health Specialists, PA
  • North Mississippi Medical Center
  • Premier Medical Group of the Hudson Valley
  • Piedmont Gastroenterology Specialists
  • PMG Research of Winston-Salem
  • University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease
  • Wheeler and Stuckey, Inc.
  • Oklahoma Foundation for Digestive Research
  • OU Physicians Building
  • Memphis Gastroenterology Group, PC
  • The West Clinic
  • Centennial Medical Center Physicians Park
  • Centennial Medical Center Tower Medical Imaging
  • Columbia Medical Group - The First Clinic Inc.
  • Radiology Alliance
  • Professional Quality Research, Inc.
  • Austin Endoscopy Center
  • Austin Gastroenterology, PA
  • Texas Center for Drug Development, Inc.
  • Austin Gastroenterology, PA
  • Cardiology Clinic of San Antonio
  • Gastroenterology Research of San Antonio
  • San Antonio Endoscopy Center
  • CNS Pharmacy
  • RGL Medical Services
  • Alpine Medical Group
  • Wasatch Clinical Research
  • Wasatch Endoscopy Center
  • University of Utah Hospital
  • Krankenhaus der Elisabethinen Linz GmbH
  • Landesklinikum St. Poelten
  • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie
  • MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia
  • DKTs Sveta Anna, Gastroenterologichen cabinet
  • Heritage Medical Research Clinic - University of Calgary
  • Vancouver Coastal Health - Vancouver General Hospital
  • Vancouver General Hospital - The Gordon and Leslie Diamond Centre
  • The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston
  • Sunnybrook Health Sciences Centre
  • CHU Hopital Nord
  • Hopital Beaujon
  • CHU Hotel-Dieu
  • Charite - Campus Berlin Mitte
  • Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly
  • Pannonia Maganorvosi Centrum Kft.
  • Clinfan Kft.
  • VU Medisch Centrum
  • Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology
  • Academisch Ziekenhuis Maastricht
  • Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii
  • Sectia Clinica Medicina Interna II
  • Hospital Clinic I Provincial de Barcelona
  • Hospital General Universitario Gregorio Marañon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

200 mg PF-05230917, Anrukinzumab active dose level

400 mg PF-05230917, Anrukinzumab active dose level

600 mg PF-05230917, Anrukinzumab active dose level

Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab
Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab
Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab
Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.
Plasma Decay Half-Life (t1/2) for Anrukinzumab
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Systemic Clearance (CL) for Anrukinzumab
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Volume of Distribution (Vz) for Anrukinzumab
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12
The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.
Total Interleukin-13 (IL-13) Level
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.
Number of Participants Who Discontinued From the Study Due to Adverse Events
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody
Neutralizing antibody was not analyzed as no participant had positive ADA samples.
Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14
Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.

Full Information

First Posted
January 25, 2011
Last Updated
November 10, 2014
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01284062
Brief Title
Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Active Ulcerative Colitis, Phase 2A, Double-blind, Randomized, PK/PD Biomarker Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
200 mg PF-05230917, Anrukinzumab active dose level
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
400 mg PF-05230917, Anrukinzumab active dose level
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
600 mg PF-05230917, Anrukinzumab active dose level
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
Intervention Type
Biological
Intervention Name(s)
Anrukinzumab
Other Intervention Name(s)
PF-05230917
Intervention Description
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Intervention Type
Biological
Intervention Name(s)
Anrukinzumab
Other Intervention Name(s)
PF-05230917
Intervention Description
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Intervention Type
Biological
Intervention Name(s)
Anrukinzumab
Other Intervention Name(s)
PF-05230917
Intervention Description
200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Fold Change From Baseline in Fecal Calprotectin at Week 14
Description
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.
Time Frame
Baseline, Week 14
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab
Description
Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Time Frame
Pre-dose to end of the dosing interval after Day 1, Week 12
Title
Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab
Description
Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Time Frame
Pre-dose to end of the dosing interval after Day 1, Week 12
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab
Description
Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.
Time Frame
Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2
Title
Plasma Decay Half-Life (t1/2) for Anrukinzumab
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Title
Systemic Clearance (CL) for Anrukinzumab
Description
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame
Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Title
Volume of Distribution (Vz) for Anrukinzumab
Description
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Time Frame
Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Title
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12
Description
The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.
Time Frame
Baseline, Week 2, 4, 8, 12
Title
Total Interleukin-13 (IL-13) Level
Time Frame
Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.
Time Frame
Baseline up to Week 32
Title
Number of Participants Who Discontinued From the Study Due to Adverse Events
Time Frame
Baseline up to Week 32
Title
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody
Description
Neutralizing antibody was not analyzed as no participant had positive ADA samples.
Time Frame
Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32
Title
Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14
Description
Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Time Frame
Baseline, Week 14
Other Pre-specified Outcome Measures:
Title
Clinical Response Rate at Week 14
Description
Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Time Frame
Week 14
Title
Clinical Remission Rate at Week 14
Description
Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Time Frame
Week 14
Title
Change From Baseline in Total Mayo Score at Week 14
Description
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Time Frame
Baseline, Week 14
Title
Number of Participants With Change From Baseline in Stool Frequency at Week 14
Description
Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Time Frame
Baseline, Week 14
Title
Number of Participants With Change From Baseline in Rectal Bleeding at Week 14
Description
Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Time Frame
Baseline, Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The Kirkland Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
UAB Hospital Department of Pharmacy
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Administrative Offices
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UAB ACIP
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Surgical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Dedicated Phase I, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
AGMG Endoscopy Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
West Coast Radiology Center
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Gastroenterology Center of Connecticut, PC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
International Clinical Research - US, LLC
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
GI Diagnostics
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Gastrointestional Associates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
St. Dominic Hospital
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Piedmont Gastroenterology Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Wheeler and Stuckey, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
OU Physicians Building
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Memphis Gastroenterology Group, PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Centennial Medical Center Physicians Park
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Centennial Medical Center Tower Medical Imaging
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Columbia Medical Group - The First Clinic Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Radiology Alliance
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Professional Quality Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Endoscopy Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Austin Gastroenterology, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Austin Gastroenterology, PA
City
Round Rocks
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Cardiology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Gastroenterology Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Endoscopy Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CNS Pharmacy
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
RGL Medical Services
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84084
Country
United States
Facility Name
Alpine Medical Group
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wasatch Endoscopy Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Krankenhaus der Elisabethinen Linz GmbH
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Landesklinikum St. Poelten
City
St. Poelten
ZIP/Postal Code
3100
Country
Austria
Facility Name
AKH Wien Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
DKTs Sveta Anna, Gastroenterologichen cabinet
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
Heritage Medical Research Clinic - University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Vancouver Coastal Health - Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver General Hospital - The Gordon and Leslie Diamond Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CHU Hopital Nord
City
Amiens Cedex 01
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU Hotel-Dieu
City
Nantes CEDEX 1
ZIP/Postal Code
44093
Country
France
Facility Name
Charite - Campus Berlin Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft.
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Clinfan Kft.
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Sectia Clinica Medicina Interna II
City
Bucuresti
ZIP/Postal Code
010816
Country
Romania
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25567115
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2421003&StudyName=Pharmacokinetics/Pharmacodynamics%20Biomarker%20Study%20in%20Active%20Ulcerative%20Colitis%20Patients
Description
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Learn more about this trial

Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

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