Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Colitis, Ulcerative	Biological: Anrukinzumab Other: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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 Patients With Active Ulcerative Colitis

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Bowel Movement Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Fold change from baseline in fecal calprotectin at Week 14. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The PK of anrukinzumab will be characterized from data obtained at pre specified time points up to 32 weeks. The pharmacokinetic parameters AUC, and half life will be estimated using noncompartmental analysis [ Time Frame: Up to Week 32 ] [ Designated as safety issue: No ]
Fold change from baseline in fecal calprotectin at Weeks 2, 4, 8, and 12. [ Time Frame: Weeks 2,4,8, and 12 ] [ Designated as safety issue: No ]
Total IL-13 (free IL-13 and IL-13 complexed with anrukinzumab) measured at pre-specified time points up to 32 weeks. [ Time Frame: Up to Week 32 ] [ Designated as safety issue: No ]
The frequency of on treatment adverse events, serious adverse events and withdrawals due to adverse events will be summarized. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Frequency of ADAs and NAbs, if observed, at pre-specified timepoints timepoints up to 32 weeks. [ Time Frame: Up to Week 32 ] [ Designated as safety issue: Yes ]
Clinical response rate at Week 14 [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Clinical remission rate at Week 14 [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Other exploratory efficacy endpoints including change from baseline in total Mayo score, change from baseline in stool frequency, rectal bleeding, and endoscopic subscores. [ Time Frame: Week 32 ] [ Designated as safety issue: No ]

Enrollment:	84
Study Start Date:	March 2011
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 200 mg PF-05230917, Anrukinzumab active dose level	Biological: Anrukinzumab 200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Other Name: PF-05230917
Experimental: Arm 2 400 mg PF-05230917, Anrukinzumab active dose level	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 Other Name: PF-05230917
Experimental: Arm 3 600 mg PF-05230917, Anrukinzumab active dose level	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. Other Name: PF-05230917
Placebo Comparator: Arm 4 Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.	Other: 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 Other Name: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284062

Hide Study Locations

Locations

United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35249
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Connecticut
Pfizer Investigational Site
Hamden, Connecticut, United States, 06518
United States, Florida
Pfizer Investigational Site
Sanford, Florida, United States, 32771
United States, Georgia
Pfizer Investigational Site
Marietta, Georgia, United States, 30060
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States, 39202
Pfizer Investigational Site
Tupelo, Mississippi, United States, 38801
United States, New York
Pfizer Investigational Site
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Tennessee
Pfizer Investigational Site
Germantown, Tennessee, United States, 38138
Pfizer Investigational Site
Memphis, Tennessee, United States, 38120
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Austin, Texas, United States, 78759
Pfizer Investigational Site
Austin, Texas, United States, 78757
Pfizer Investigational Site
Houston, Texas, United States, 77081
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84119
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
Pfizer Investigational Site
West Jordan, Utah, United States, 84084
Austria
Pfizer Investigational Site
Linz, Austria, 4020
Pfizer Investigational Site
St. Poelten, Austria, 3100
Pfizer Investigational Site
Wien, Austria, 1090
Bulgaria
Pfizer Investigational Site
Ruse, Bulgaria, 7002
Pfizer Investigational Site
Sofia, Bulgaria, 1606
Pfizer Investigational Site
Sofia, Bulgaria, 1750
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 5G2
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
France
Pfizer Investigational Site
Amiens Cedex 01, France, 80054
Pfizer Investigational Site
Clichy, France, 92110
Pfizer Investigational Site
Nantes CEDEX 1, France, 44093
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Kiel, Germany, 24105
Pfizer Investigational Site
Minden, Germany, 32423
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1136
Pfizer Investigational Site
Budapest, Hungary, 1125
Pfizer Investigational Site
Szekszard, Hungary, 7100
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Pfizer Investigational Site
Amsterdam, Netherlands, 1105 AZ
Pfizer Investigational Site
Maastricht, Netherlands, 6229 HX
Poland
Pfizer Investigational Site
Wroclaw, Dolnoslaskie, Poland, 50-556
Pfizer Investigational Site
Warszawa, Poland, 02-507
Romania
Pfizer Investigational Site
Bucuresti, Romania
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Madrid, Spain, 28007

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01284062 History of Changes
Other Study ID Numbers:	B2421003, IMA-638 Anti-IL13 mAb
Study First Received:	January 25, 2011
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Active Ulcerative Colitis
Phase 2A
Double-blind
Randomized
PK/PD Biomarker Study

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013