Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease - Full Text View

Purpose

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

Condition	Intervention	Phase
Crohn's Disease	Drug: Placebo Drug: BMS-936557 (Anti-IP-10 Antibody)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Clinical remission (CDAI score of <150) [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
CDAI: Crohn's Disease Activity Index

Secondary Outcome Measures:

Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150) [ Time Frame: Week 7 and Week 11 ] [ Designated as safety issue: No ]
Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150) [ Time Frame: Week 7 and Week 11 ] [ Designated as safety issue: No ]
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values [ Time Frame: Week 11 ] [ Designated as safety issue: Yes ]
AE - Adverse Event SAE - Serious Adverse Event

Estimated Enrollment:	130
Study Start Date:	December 2011
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1: Induction Placebo	Drug: Placebo Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Experimental: Cohort 2: Induction Anti-IP-10 Antibody	Drug: BMS-936557 (Anti-IP-10 Antibody) Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks Other Name: Anti-IP-10 Antibody
Experimental: Cohort 3: Induction Anti-IP-10 Antibody	Drug: BMS-936557 (Anti-IP-10 Antibody) Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks Other Name: Anti-IP-10 Antibody
Experimental: Cohort 1: Maintenance Placebo	Drug: Placebo Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
Experimental: Cohort 2: Maintenance Anti-IP-10 Antibody	Drug: BMS-936557 (Anti-IP-10 Antibody) Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Experimental: Cohort 3: Maintenance Anti-IP-10 Antibody	Drug: BMS-936557 (Anti-IP-10 Antibody) Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Experimental: Cohort 1: Open Label Anti-IP-10 Antibody	Drug: BMS-936557 (Anti-IP-10 Antibody) Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open

Detailed Description:

Anti-IP10: Anti Interferon-inducible ligand 10

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)

Exclusion Criteria:

Ulcerative colitis (UC) or indeterminate colitis
Short bowel syndrome
Known stricture or noninflammatory stenosis leading to symptoms of obstruction
Current stoma or current need for colostomy or ileostomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466374

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 29 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01466374 History of Changes
Other Study ID Numbers:	IM129-008, 2011-002981-19
Study First Received:	November 3, 2011
Last Updated:	March 14, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013