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NCT01284062 · ClinicalTrials.gov registry record · Phase 2

Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target

NCT01284062 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 84 participants.

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The verdict

NCT01284062, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target

Study 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.

Interventions

  • OTHER placebo
  • BIOLOGICAL Anrukinzumab

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2011-03
Est. Completion 2013-04
Phase Phase 2

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01284062

The ClinicalTrials.gov registry entry for NCT01284062 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01284062 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01284062 about?

NCT01284062 is a clinical study titled "Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients". 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...

What is the current status of trial NCT01284062?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2011-03. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01284062?

The interventions under investigation include: placebo (OTHER), Anrukinzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01284062?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.