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Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

NCT ID: NCT01284062

Last Updated: 2014-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

200 mg PF-05230917, Anrukinzumab active dose level

Group Type EXPERIMENTAL

Anrukinzumab

Intervention Type BIOLOGICAL

200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

Arm 2

400 mg PF-05230917, Anrukinzumab active dose level

Group Type EXPERIMENTAL

Anrukinzumab

Intervention Type BIOLOGICAL

200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

Arm 3

600 mg PF-05230917, Anrukinzumab active dose level

Group Type EXPERIMENTAL

Anrukinzumab

Intervention Type BIOLOGICAL

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.

Arm 4

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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Anrukinzumab

200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

Intervention Type BIOLOGICAL

Anrukinzumab

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

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.

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Other Intervention Names

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PF-05230917 PF-05230917 PF-05230917

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The Kirkland Clinic

Birmingham, Alabama, United States

Site Status

UAB Hospital

Birmingham, Alabama, United States

Site Status

UAB Hospital Department of Pharmacy

Birmingham, Alabama, United States

Site Status

Administrative Offices

Birmingham, Alabama, United States

Site Status

UAB ACIP

Birmingham, Alabama, United States

Site Status

Arizona Surgical Center

Phoenix, Arizona, United States

Site Status

Dedicated Phase I, Inc.

Phoenix, Arizona, United States

Site Status

AGMG Endoscopy Center

Anaheim, California, United States

Site Status

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

West Coast Radiology Center

Santa Ana, California, United States

Site Status

Endoscopy Center of Connecticut, LLC

Hamden, Connecticut, United States

Site Status

Gastroenterology Center of Connecticut, PC

Hamden, Connecticut, United States

Site Status

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Site Status

International Clinical Research - US, LLC

Sanford, Florida, United States

Site Status

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, United States

Site Status

GI Diagnostics

Marietta, Georgia, United States

Site Status

Gastrointestinal Associates, PA

Jackson, Mississippi, United States

Site Status

Gastrointestional Associates, PA

Jackson, Mississippi, United States

Site Status

St. Dominic Hospital

Jackson, Mississippi, United States

Site Status

Digestive Health Specialists, PA

Tupelo, Mississippi, United States

Site Status

North Mississippi Medical Center

Tupelo, Mississippi, United States

Site Status

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Site Status

Piedmont Gastroenterology Specialists

Winston-Salem, North Carolina, United States

Site Status

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease

Cleveland, Ohio, United States

Site Status

Wheeler and Stuckey, Inc.

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Site Status

OU Physicians Building

Oklahoma City, Oklahoma, United States

Site Status

Memphis Gastroenterology Group, PC

Germantown, Tennessee, United States

Site Status

The West Clinic

Memphis, Tennessee, United States

Site Status

Centennial Medical Center Physicians Park

Nashville, Tennessee, United States

Site Status

Centennial Medical Center Tower Medical Imaging

Nashville, Tennessee, United States

Site Status

Columbia Medical Group - The First Clinic Inc.

Nashville, Tennessee, United States

Site Status

Radiology Alliance

Nashville, Tennessee, United States

Site Status

Professional Quality Research, Inc.

Austin, Texas, United States

Site Status

Austin Endoscopy Center

Austin, Texas, United States

Site Status

Austin Gastroenterology, PA

Austin, Texas, United States

Site Status

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Site Status

Austin Gastroenterology, PA

Round Rocks, Texas, United States

Site Status

Cardiology Clinic of San Antonio

San Antonio, Texas, United States

Site Status

Gastroenterology Research of San Antonio

San Antonio, Texas, United States

Site Status

San Antonio Endoscopy Center

San Antonio, Texas, United States

Site Status

CNS Pharmacy

Murray, Utah, United States

Site Status

RGL Medical Services

Salt Lake City, Utah, United States

Site Status

Alpine Medical Group

Salt Lake City, Utah, United States

Site Status

Wasatch Clinical Research

Salt Lake City, Utah, United States

Site Status

Wasatch Endoscopy Center

Salt Lake City, Utah, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Krankenhaus der Elisabethinen Linz GmbH

Linz, , Austria

Site Status

Landesklinikum St. Poelten

Sankt Pölten, , Austria

Site Status

AKH Wien Universitaetsklinik fuer Innere Medizin III

Vienna, , Austria

Site Status

MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie

Rousse, , Bulgaria

Site Status

MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia

Sofia, , Bulgaria

Site Status

DKTs Sveta Anna, Gastroenterologichen cabinet

Sofia, , Bulgaria

Site Status

Heritage Medical Research Clinic - University of Calgary

Calgary, Alberta, Canada

Site Status

Vancouver Coastal Health - Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Vancouver General Hospital - The Gordon and Leslie Diamond Centre

Vancouver, British Columbia, Canada

Site Status

The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston

Kingston, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

CHU Hopital Nord

Amiens, , France

Site Status

Hopital Beaujon

Clichy, , France

Site Status

CHU Hotel-Dieu

Nantes, , France

Site Status

Charite - Campus Berlin Mitte

Berlin, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status

Gastroenterologische Gemeinschaftspraxis Minden

Minden, , Germany

Site Status

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly

Budapest, , Hungary

Site Status

Pannonia Maganorvosi Centrum Kft.

Budapest, , Hungary

Site Status

Clinfan Kft.

Szekszárd, , Hungary

Site Status

VU Medisch Centrum

Amsterdam, , Netherlands

Site Status

Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology

Amsterdam, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii

Warsaw, , Poland

Site Status

Sectia Clinica Medicina Interna II

Bucharest, , Romania

Site Status

Hospital Clinic I Provincial de Barcelona

Barcelona, Barcelona, Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Site Status

Countries

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United States Austria Bulgaria Canada France Germany Hungary Netherlands Poland Romania Spain

References

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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.

Reference Type DERIVED
PMID: 25567115 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2421003&StudyName=Pharmacokinetics/Pharmacodynamics%20Biomarker%20Study%20in%20Active%20Ulcerative%20Colitis%20Patients

To obtain contact information for a study center near you, click here.

Other Identifiers

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IMA-638 Anti-IL13 mAb

Identifier Type: -

Identifier Source: secondary_id

2010-023762-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B2421003

Identifier Type: -

Identifier Source: org_study_id