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

Shire

Status and phase

Completed

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: PF-00547659 SC Injection

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01620255

2012-002030-37 (EudraCT Number)

A7281009

TURANDOT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

357 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with diagnosis of Ulcerative Colitis for 3 or more months.
Ulcerative colitis must be active beyond the rectum.
Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points

Exclusion criteria

Pregnant or breast feeding.
Diagnosis of indeterminate colitis or Crohn's Disease
Subjects with history of colonic or small bowel obstruction or resection.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

357 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug Dose Level 1

Experimental group

Treatment:

Drug: PF-00547659 SC Injection

Drug Dose Level 2

Experimental group

Treatment:

Drug: PF-00547659 SC Injection

Drug Dose Level 3

Experimental group

Treatment:

Drug: PF-00547659 SC Injection

Drug Dose Level 4

Experimental group

Treatment:

Drug: PF-00547659 SC Injection

Trial contacts and locations

190

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