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A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

NCT01620255 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2021-06-11

Study results available
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Summary

To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

Conditions

Interventions

DRUG

Placebo

Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks

DRUG

PF-00547659 SC Injection

Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks

DRUG

PF-00547659 SC Injection

Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks

DRUG

PF-00547659 SC Injection

Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks

DRUG

PF-00547659 SC Injection

Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-02
Primary Completion
2014-09-22
Completion
2016-02-04

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620255 on ClinicalTrials.gov