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B0151005 Open-Label Extension Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2

B0151005 Open-Label Extension Study

A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

NCT01345318•Pfizer

Summary

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
•Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

Exclusion Criteria

•Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
•Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.

Locations (127)

Simon Medical Imaging

Scottsdale, Arizona, United States

Digestive Health Research Unit

Scottsdale, Arizona, United States

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Adobe Surgery Center

Tucson, Arizona, United States

Rocky Mountain Gastroenterology Associates

Lakewood, Colorado, United States

Rocky Mountain Gastroenterology

Littleton, Colorado, United States

Rocky Mountain Clinical Research, LLC.

Wheat Ridge, Colorado, United States

Rocky Mountain Clinical Research, LLC

Wheat Ridge, Colorado, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Gastroenterology Consultants of Clearwater

Clearwater, Florida, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

March 1, 2016

Completion Date

March 1, 2016

Last Updated

January 12, 2024

Enrollment

191

ACTUAL participants

Conditions

Crohn's Disease

Interventions

PF-04236921

BIOLOGICAL

PF-04236921

BIOLOGICAL

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 12, 2024Data 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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B0151005 Open-Label Extension Study

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

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

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