Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

NCT01284062

Last updated date
Study Location
The Kirkland Clinic
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1
    200 mg PF-05230917, Anrukinzumab active dose level
    Intervention: Biological: Anrukinzumab
  • Experimental: Arm 2
    400 mg PF-05230917, Anrukinzumab active dose level
    Intervention: Biological: Anrukinzumab
  • Experimental: Arm 3
    600 mg PF-05230917, Anrukinzumab active dose level
    Intervention: Biological: Anrukinzumab
  • Placebo Comparator: Arm 4
    Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
    Intervention: Other: placebo
Publications * Reinisch W, Panés 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2013)
84
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2011)
80
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bulgaria,   Canada,   France,   Germany,   Hungary,   Netherlands,   Poland,   Romania,   Spain,   United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT01284062
Other Study ID Numbers  ICMJE B2421003
IMA-638 Anti-IL13 mAb
2010-023762-49 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP