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Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

2014年11月10日 更新者：Pfizer

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

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

84

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 保加利亚
      • Ruse、保加利亚、7002
        • MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie
      • Sofia、保加利亚、1606
        • MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia
      • Sofia、保加利亚、1750
        • DKTs Sveta Anna, Gastroenterologichen cabinet
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4Z6
        • Heritage Medical Research Clinic - University Of Calgary
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • Vancouver Coastal Health - Vancouver General Hospital
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • Vancouver General Hospital - The Gordon and Leslie Diamond Centre
    • Ontario
      • Kingston、Ontario、加拿大、K7L 5G2
        • The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston
      • Toronto、Ontario、加拿大、M4N 3M5
        • Sunnybrook Health Sciences Centre
  • 匈牙利
      • Budapest、匈牙利、1136
        • Pannonia Maganorvosi Centrum Kft.
      • Budapest、匈牙利、1125
        • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly
      • Szekszard、匈牙利、7100
        • Clinfan Kft.
  • 奥地利
      • Linz、奥地利、4020
        • Krankenhaus der Elisabethinen Linz GmbH
      • St. Poelten、奥地利、3100
        • Landesklinikum St. Poelten
      • Wien、奥地利、1090
        • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • 德国
      • Berlin、德国、10117
        • Charite - Campus Berlin Mitte
      • Heidelberg、德国、69120
        • Universitaetsklinikum Heidelberg
      • Kiel、德国、24105
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
      • Minden、德国、32423
        • Gastroenterologische Gemeinschaftspraxis Minden
  • 法国
      • Amiens Cedex 01、法国、80054
        • CHU Hôpital Nord
      • Clichy、法国、92110
        • Hopital Beaujon
      • Nantes CEDEX 1、法国、44093
        • CHU Hôtel-Dieu
  • 波兰
      • Warszawa、波兰、02-507
        • Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii
  • 罗马尼亚
      • Bucuresti、罗马尼亚、010816
        • Sectia Clinica Medicina Interna II
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35249
        • UAB Hospital Department of Pharmacy
      • Birmingham、Alabama、美国、35233
        • UAB Hospital
      • Birmingham、Alabama、美国、35233
        • The Kirkland Clinic
      • Birmingham、Alabama、美国、35294
        • Administrative Offices
      • Birmingham、Alabama、美国、35294
        • UAB ACIP
    • Arizona
      • Phoenix、Arizona、美国、85013
        • Dedicated Phase I, Inc.
      • Phoenix、Arizona、美国、85006
        • Arizona Surgical Center
    • California
      • Anaheim、California、美国、92801
        • Anaheim Clinical Trials, LLC
      • Anaheim、California、美国、92801
        • AGMG Endoscopy Center
      • Santa Ana、California、美国、92705
        • West Coast Radiology Center
    • Connecticut
      • Hamden、Connecticut、美国、06518
        • Medical Research Center of Connecticut, LLC
      • Hamden、Connecticut、美国、06518
        • Gastroenterology Center of Connecticut, PC
      • Hamden、Connecticut、美国、06518
        • Endoscopy Center of Connecticut, LLC
    • Florida
      • Sanford、Florida、美国、32771
        • International Clinical Research - US, LLC
    • Georgia
      • Marietta、Georgia、美国、30060
        • Gastrointestinal Specialists of Georgia, PC
      • Marietta、Georgia、美国、30067
        • GI Diagnostics
    • Mississippi
      • Jackson、Mississippi、美国、39216
        • St. Dominic Hospital
      • Jackson、Mississippi、美国、39202
        • Gastrointestinal Associates, PA
      • Jackson、Mississippi、美国、39202
        • Gastrointestional Associates, PA
      • Tupelo、Mississippi、美国、38801
        • North Mississippi Medical Center
      • Tupelo、Mississippi、美国、38801
        • Digestive Health Specialists, PA
    • New York
      • Poughkeepsie、New York、美国、12601
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Winston-Salem、North Carolina、美国、27103
        • PMG Research of Winston-Salem
      • Winston-Salem、North Carolina、美国、27103
        • Piedmont Gastroenterology Specialists
    • Ohio
      • Cleveland、Ohio、美国、44106
        • University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • Oklahoma Foundation for Digestive Research
      • Oklahoma City、Oklahoma、美国、73104
        • OU Physicians Building
      • Oklahoma City、Oklahoma、美国、73103
        • Wheeler and Stuckey, Inc.
    • Tennessee
      • Germantown、Tennessee、美国、38138
        • Memphis Gastroenterology Group, PC
      • Memphis、Tennessee、美国、38120
        • The West Clinic
      • Nashville、Tennessee、美国、37203
        • Centennial Medical Center Physicians Park
      • Nashville、Tennessee、美国、37203
        • Centennial Medical Center Tower Medical Imaging
      • Nashville、Tennessee、美国、37203
        • Columbia Medical Group - The First Clinic Inc.
      • Nashville、Tennessee、美国、37203
        • Radiology Alliance
    • Texas
      • Austin、Texas、美国、78705
        • Professional Quality Research, Inc.
      • Austin、Texas、美国、78757
        • Austin Endoscopy Center
      • Austin、Texas、美国、78757
        • Austin Gastroenterology, PA
      • Houston、Texas、美国、77081
        • Texas Center for Drug Development, Inc.
      • Round Rocks、Texas、美国、78681
        • Austin Gastroenterology, PA
      • San Antonio、Texas、美国、78229
        • Cardiology Clinic of San Antonio
      • San Antonio、Texas、美国、78229
        • Gastroenterology Research of San Antonio
      • San Antonio、Texas、美国、78229
        • San Antonio Endoscopy Center
    • Utah
      • Murray、Utah、美国、84123
        • CNS Pharmacy
      • Salt Lake City、Utah、美国、84132
        • University of Utah Hospital
      • Salt Lake City、Utah、美国、84102
        • Alpine Medical Group
      • Salt Lake City、Utah、美国、84107
        • Wasatch Clinical Research
      • Salt Lake City、Utah、美国、84124
        • Wasatch Endoscopy Center
      • Salt Lake City、Utah、美国、84084
        • RGL Medical Services
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • VU Medisch Centrum
      • Amsterdam、荷兰、1105 AZ
        • Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology
      • Maastricht、荷兰、6229 HX
        • Academisch Ziekenhuis Maastricht
  • 西班牙
      • Barcelona、西班牙、08036
        • Hospital Clinic i Provincial de Barcelona
      • Madrid、西班牙、28007
        • Hospital General Universitario Gregorio Marañón

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm 1
200 mg PF-05230917, Anrukinzumab active dose level
生物：Anrukinzumab
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
其他名称：
  • PF-05230917
生物：Anrukinzumab
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
其他名称：
  • PF-05230917
生物：Anrukinzumab
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.
其他名称：
  • PF-05230917
实验性的：Arm 2
400 mg PF-05230917, Anrukinzumab active dose level
生物：Anrukinzumab
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
其他名称：
  • PF-05230917
生物：Anrukinzumab
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
其他名称：
  • PF-05230917
生物：Anrukinzumab
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.
其他名称：
  • PF-05230917
实验性的：Arm 3
600 mg PF-05230917, Anrukinzumab active dose level
生物：Anrukinzumab
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
其他名称：
  • PF-05230917
生物：Anrukinzumab
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
其他名称：
  • PF-05230917
生物：Anrukinzumab
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.
其他名称：
  • PF-05230917
安慰剂比较：Arm 4
Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
其他：placebo
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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Fold Change From Baseline in Fecal Calprotectin at Week 14
大体时间：Baseline, 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

次要结果测量

结果测量
措施说明
大体时间
Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab
大体时间：Pre-dose to end of the dosing interval after Day 1, Week 12
Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Pre-dose to end of the dosing interval after Day 1, Week 12
Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab
大体时间：Pre-dose to end of the dosing interval after Day 1, Week 12
Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
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
大体时间：Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2
Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.
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
大体时间：Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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
大体时间：Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Volume of Distribution (Vz) for Anrukinzumab
大体时间：Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
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.
Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12
大体时间：Baseline, Week 2, 4, 8, 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.
Baseline, Week 2, 4, 8, 12
Total Interleukin-13 (IL-13) Level
大体时间：Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32
Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline up to Week 32
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.
Baseline up to Week 32
Number of Participants Who Discontinued From the Study Due to Adverse Events
大体时间：Baseline up to Week 32
Baseline up to Week 32
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody
大体时间：Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32
Neutralizing antibody was not analyzed as no participant had positive ADA samples.
Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32
Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14
大体时间：Baseline, 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.
Baseline, Week 14

其他结果措施

结果测量
措施说明
大体时间
Clinical Response Rate at Week 14
大体时间：Week 14
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.
Week 14
Clinical Remission Rate at Week 14
大体时间：Week 14
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.
Week 14
Change From Baseline in Total Mayo Score at Week 14
大体时间：Baseline, Week 14
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.
Baseline, Week 14
Number of Participants With Change From Baseline in Stool Frequency at Week 14
大体时间：Baseline, Week 14
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.
Baseline, Week 14
Number of Participants With Change From Baseline in Rectal Bleeding at Week 14
大体时间：Baseline, Week 14
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.
Baseline, Week 14

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (实际的)

2013年4月1日

研究完成 (实际的)

2013年4月1日

研究注册日期

首次提交

2011年1月25日

首先提交符合 QC 标准的

2011年1月25日

首次发布 (估计)

2011年1月26日

研究记录更新

最后更新发布 (估计)

2014年11月18日

上次提交的符合 QC 标准的更新

2014年11月10日

最后验证

2014年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • B2421003
  • IMA-638 Anti-IL13 mAb
  • 2010-023762-49 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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