Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
2014년 11월 10일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
84
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Amsterdam, 네덜란드, 1081 HV
- VU Medisch Centrum
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Amsterdam, 네덜란드, 1105 AZ
- Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology
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Maastricht, 네덜란드, 6229 HX
- Academisch Ziekenhuis Maastricht
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Berlin, 독일, 10117
- Charite - Campus Berlin Mitte
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Heidelberg, 독일, 69120
- UniversitaetsKlinikum Heidelberg
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Kiel, 독일, 24105
- Universitaetsklinikum Schleswig-Holstein, Campus Kiel
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Minden, 독일, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
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Bucuresti, 루마니아, 010816
- Sectia Clinica Medicina Interna II
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Alabama
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Birmingham, Alabama, 미국, 35249
- UAB Hospital Department of Pharmacy
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Birmingham, Alabama, 미국, 35233
- UAB Hospital
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Birmingham, Alabama, 미국, 35233
- The Kirkland Clinic
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Birmingham, Alabama, 미국, 35294
- Administrative Offices
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Birmingham, Alabama, 미국, 35294
- UAB ACIP
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Arizona
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Phoenix, Arizona, 미국, 85013
- Dedicated Phase I, Inc.
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Phoenix, Arizona, 미국, 85006
- Arizona Surgical Center
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California
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Anaheim, California, 미국, 92801
- Anaheim Clinical Trials, LLC
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Anaheim, California, 미국, 92801
- AGMG Endoscopy Center
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Santa Ana, California, 미국, 92705
- West Coast Radiology Center
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Connecticut
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Hamden, Connecticut, 미국, 06518
- Medical Research Center of Connecticut, LLC
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Hamden, Connecticut, 미국, 06518
- Gastroenterology Center of Connecticut, PC
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Hamden, Connecticut, 미국, 06518
- Endoscopy Center of Connecticut, LLC
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Florida
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Sanford, Florida, 미국, 32771
- International Clinical Research - US, LLC
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Georgia
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Marietta, Georgia, 미국, 30060
- Gastrointestinal Specialists of Georgia, PC
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Marietta, Georgia, 미국, 30067
- GI Diagnostics
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Mississippi
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Jackson, Mississippi, 미국, 39216
- St. Dominic Hospital
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Jackson, Mississippi, 미국, 39202
- Gastrointestinal Associates, PA
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Jackson, Mississippi, 미국, 39202
- Gastrointestional Associates, PA
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Tupelo, Mississippi, 미국, 38801
- North Mississippi Medical Center
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Tupelo, Mississippi, 미국, 38801
- Digestive Health Specialists, PA
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New York
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Poughkeepsie, New York, 미국, 12601
- Premier Medical Group of the Hudson Valley
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North Carolina
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Winston-Salem, North Carolina, 미국, 27103
- PMG Research of Winston-Salem
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Winston-Salem, North Carolina, 미국, 27103
- Piedmont Gastroenterology Specialists
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma Foundation for Digestive Research
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Oklahoma City, Oklahoma, 미국, 73104
- OU Physicians Building
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Oklahoma City, Oklahoma, 미국, 73103
- Wheeler and Stuckey, Inc.
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Tennessee
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Germantown, Tennessee, 미국, 38138
- Memphis Gastroenterology Group, PC
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Memphis, Tennessee, 미국, 38120
- The West Clinic
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Nashville, Tennessee, 미국, 37203
- Centennial Medical Center Physicians Park
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Nashville, Tennessee, 미국, 37203
- Centennial Medical Center Tower Medical Imaging
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Nashville, Tennessee, 미국, 37203
- Columbia Medical Group - The First Clinic Inc.
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Nashville, Tennessee, 미국, 37203
- Radiology Alliance
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Texas
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Austin, Texas, 미국, 78705
- Professional Quality Research, Inc.
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Austin, Texas, 미국, 78757
- Austin Endoscopy Center
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Austin, Texas, 미국, 78757
- Austin Gastroenterology, PA
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Houston, Texas, 미국, 77081
- Texas Center for Drug Development, Inc.
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Round Rocks, Texas, 미국, 78681
- Austin Gastroenterology, PA
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San Antonio, Texas, 미국, 78229
- Cardiology Clinic of San Antonio
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San Antonio, Texas, 미국, 78229
- Gastroenterology Research of San Antonio
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San Antonio, Texas, 미국, 78229
- San Antonio Endoscopy Center
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Utah
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Murray, Utah, 미국, 84123
- CNS Pharmacy
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Salt Lake City, Utah, 미국, 84132
- University of Utah Hospital
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Salt Lake City, Utah, 미국, 84102
- Alpine Medical Group
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Salt Lake City, Utah, 미국, 84107
- Wasatch Clinical Research
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Salt Lake City, Utah, 미국, 84124
- Wasatch Endoscopy Center
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Salt Lake City, Utah, 미국, 84084
- RGL Medical Services
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Ruse, 불가리아, 7002
- MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie
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Sofia, 불가리아, 1606
- MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia
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Sofia, 불가리아, 1750
- DKTs Sveta Anna, Gastroenterologichen cabinet
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Barcelona, 스페인, 08036
- Hospital Clinic I Provincial De Barcelona
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Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Marañon
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Linz, 오스트리아, 4020
- Krankenhaus der Elisabethinen Linz GmbH
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St. Poelten, 오스트리아, 3100
- Landesklinikum St. Poelten
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Wien, 오스트리아, 1090
- AKH Wien Universitaetsklinik fuer Innere Medizin III
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Alberta
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Calgary, Alberta, 캐나다, T2N 4Z6
- Heritage Medical Research Clinic - University Of Calgary
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Vancouver Coastal Health - Vancouver General Hospital
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Vancouver General Hospital - The Gordon and Leslie Diamond Centre
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Ontario
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Kingston, Ontario, 캐나다, K7L 5G2
- The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Sciences Centre
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Warszawa, 폴란드, 02-507
- Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii
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Amiens Cedex 01, 프랑스, 80054
- CHU Hopital Nord
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Clichy, 프랑스, 92110
- Hôpital Beaujon
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Nantes CEDEX 1, 프랑스, 44093
- CHU Hotel-Dieu
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Budapest, 헝가리, 1136
- Pannonia Maganorvosi Centrum Kft.
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Budapest, 헝가리, 1125
- Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly
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Szekszard, 헝가리, 7100
- Clinfan Kft.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Arm 1
200 mg PF-05230917, Anrukinzumab active dose level
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200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
다른 이름들:
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
다른 이름들:
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.
다른 이름들:
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실험적: Arm 2
400 mg PF-05230917, Anrukinzumab active dose level
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200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
다른 이름들:
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
다른 이름들:
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.
다른 이름들:
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실험적: Arm 3
600 mg PF-05230917, Anrukinzumab active dose level
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200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
다른 이름들:
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
다른 이름들:
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.
다른 이름들:
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위약 비교기: Arm 4
Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fold Change From Baseline in Fecal Calprotectin at Week 14
기간: Baseline, Week 14
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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.
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Baseline, Week 14
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab
기간: Pre-dose to end of the dosing interval after Day 1, Week 12
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Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
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Pre-dose to end of the dosing interval after Day 1, Week 12
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Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab
기간: Pre-dose to end of the dosing interval after Day 1, Week 12
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Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
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Pre-dose to end of the dosing interval after Day 1, Week 12
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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab
기간: Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2
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Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.
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Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2
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Plasma Decay Half-Life (t1/2) for Anrukinzumab
기간: Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
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Systemic Clearance (CL) for Anrukinzumab
기간: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
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CL is a quantitative measure of the rate at which a drug substance is removed from the body.
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Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
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Volume of Distribution (Vz) for Anrukinzumab
기간: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
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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.
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Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
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Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12
기간: Baseline, Week 2, 4, 8, 12
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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.
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Baseline, Week 2, 4, 8, 12
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Total Interleukin-13 (IL-13) Level
기간: Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32
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Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Baseline up to Week 32
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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.
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Baseline up to Week 32
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Number of Participants Who Discontinued From the Study Due to Adverse Events
기간: Baseline up to Week 32
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Baseline up to Week 32
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Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody
기간: Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32
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Neutralizing antibody was not analyzed as no participant had positive ADA samples.
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Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32
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Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14
기간: Baseline, Week 14
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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.
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Baseline, Week 14
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Response Rate at Week 14
기간: Week 14
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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.
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Week 14
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Clinical Remission Rate at Week 14
기간: Week 14
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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.
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Week 14
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Change From Baseline in Total Mayo Score at Week 14
기간: Baseline, Week 14
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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.
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Baseline, Week 14
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Number of Participants With Change From Baseline in Stool Frequency at Week 14
기간: 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
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Number of Participants With Change From Baseline in Rectal Bleeding at Week 14
기간: 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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 3월 1일
기본 완료 (실제)
2013년 4월 1일
연구 완료 (실제)
2013년 4월 1일
연구 등록 날짜
최초 제출
2011년 1월 25일
QC 기준을 충족하는 최초 제출
2011년 1월 25일
처음 게시됨 (추정)
2011년 1월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 11월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 11월 10일
마지막으로 확인됨
2014년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .