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Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

NCT01276509•Shire

View on ClinicalTrials.gov

Summary

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
•hsCRP greater than 3mg/L
•Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria

•Pregnant or breast feeding
•Short bowel syndrome due to multiple small bowel resections
•Presence of a stoma

Locations (137)

Clopton Clinic

Jonesboro, Arkansas, United States

Gastroenterology Specialists of Arkansas

Jonesboro, Arkansas, United States

Little Rock Diagnostic Clinic, P.A.

Little Rock, Arkansas, United States

UCSD Medical Center-Thornton Hospital

La Jolla, California, United States

Community Clinical Trials

Orange, California, United States

Gastro Diagnostics

Orange, California, United States

Inland Gastroenterology Medical Associates, Inc.

Redlands, California, United States

BioMark Research Inc.

Whittier, California, United States

Clinical Research of the Rockies

Lafayette, Colorado, United States

Rocky Mountain Gastroenterology Associates

Thornton, Colorado, United States

Key Dates

Start Date

April 6, 2011

Primary Completion Date

February 7, 2014

Completion Date

October 9, 2015

Last Updated

June 3, 2021

Enrollment

265

ACTUAL participants

Conditions

Crohn's Disease

Interventions

PF-00547659 SC injection

DRUG

PF-00547659 SC injection

DRUG

PF-00547659 SC injection

DRUG

PF-00547659 SC injection

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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