Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis - Full Text View

Purpose

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

Condition	Intervention	Phase
Colitis, Ulcerative	Drug: Placebo Drug: 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 IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo [ Time Frame: End of Induction [Week 11, Induction Period-78 (IP-78)] ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of the subjects with clinical response of BMS-936557 with that of the placebo [ Time Frame: IP-78 (Week 11) ] [ Designated as safety issue: No ]
Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo [ Time Frame: IP-78 (Week 11) ] [ Designated as safety issue: No ]
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values [ Time Frame: IP-78 (Week 11) ] [ Designated as safety issue: Yes ]
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo [ Time Frame: Baseline (IP-1, Week 1) and IP-78 (Week 11) ] [ Designated as safety issue: No ]

Estimated Enrollment:	289
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1: Induction Placebo or Anti-IP-10 Antibody	Drug: Placebo Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks Drug: Anti-IP-10 Antibody Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Experimental: Cohort 2: Induction Placebo or Anti-IP-10 Antibody	Drug: Placebo Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks Drug: Anti-IP-10 Antibody Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Experimental: Cohort 3: Induction Placebo or Anti-IP-10 Antibody	Drug: Placebo Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks Drug: Anti-IP-10 Antibody Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks Drug: Anti-IP-10 Antibody Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Experimental: Maintenance Placebo or Anti-IP-10 Antibody	Drug: Placebo Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days Drug: Anti-IP-10 Antibody Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days Drug: Anti-IP-10 Antibody Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days Drug: Anti-IP-10 Antibody Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Open Label	Drug: Anti-IP-10 Antibody Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
Mayo score ≥6 with an endoscopic subscore of ≥2
Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Exclusion Criteria:

Diagnosis of Crohn's Disease or Indeterminate Colitis
Diagnosis of UC that is limited to the rectum
Evidence of fulminant colitis, toxic megacolon, or bowel perforation
Current need for a colostomy or ileostomy
Previous total or subtotal colectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294410

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 78 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure 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:	NCT01294410 History of Changes
Other Study ID Numbers:	IM129-005, 2010-022506-41
Study First Received:	February 10, 2011
Last Updated:	August 1, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council Mexico: Federal Commission for Sanitary Risks Protection Brazil: National Health Surveillance Agency Brazil: National Committee of Ethics in Research South Africa: Medicines Control Council France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Austria: Federal Office for Safety in Health Care Germany: Paul-Ehrlich-Institut Hungary: National Institute of Pharmacy Poland: National Institute of Medicines Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Italy: Ministry of Health Italy: Ethics Committee Italy: National Institute of Health Italy: The Italian Medicines Agency

Additional relevant MeSH terms:

Colitis, Ulcerative
Colitis
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases

Inflammatory Bowel Diseases
Pathologic Processes
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013