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A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)

NCT01287897•Pfizer

View on ClinicalTrials.gov

Summary

This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have failed or are intolerant to anti TNFs
•hsCRP greater or equal to 5.0 mg/L
•Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening

Exclusion Criteria

•Pregnant or breastfeeding women
•Crohn's Disease with active fistulae or abscess
•History of diverticulitis or symptomatic diverticulosis
•Abnormality in hematology or chemistry profiles at screening

Locations (193)

UAB Hospital

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Simon Medical Imaging

Scottsdale, Arizona, United States

Digestive Health Research Unit

Scottsdale, Arizona, United States

Adobe Clinical Research, Llc

Tucson, Arizona, United States

Radiology Ltd

Tucson, Arizona, United States

UCSF Endoscopy Unit at Mount Zion

San Francisco, California, United States

University of California - San Francisco

San Francisco, California, United States

University of California San Francisco at Mount Zion

San Francisco, California, United States

Rocky Mountain Clinical Research, LLC

Denver, Colorado, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

September 1, 2014

Completion Date

February 1, 2015

Last Updated

January 21, 2016

Enrollment

250

ACTUAL participants

Conditions

Crohn's Disease

Interventions

PF-04236921 SC injection

DRUG

PF-04236921 SC injection

DRUG

PF-04236921 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

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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: January 21, 2016Data 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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A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

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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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease