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Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
The Kirkland Clinic
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
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

- 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.

NCT01284062
Pfizer
Completed
Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

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Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Colitis, Ulcerative
  • 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
  • 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
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.
 
Completed
84
April 2013
April 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bulgaria,   Canada,   France,   Germany,   Hungary,   Netherlands,   Poland,   Romania,   Spain,   United States
Belgium
 
NCT01284062
B2421003
IMA-638 Anti-IL13 mAb
2010-023762-49 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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