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Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
This study has been terminated.
Sponsor:
Alder Biopharmaceuticals, Inc.
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01545050
First received: March 1, 2012
Last updated: July 24, 2015
Last verified: July 2015
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Purpose
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.
| Condition | Intervention | Phase |
|---|---|---|
| Crohn's Disease | Biological: Placebo matching with BMS-945429 Biological: BMS-945429 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe 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 Alder Biopharmaceuticals, Inc.:
Primary Outcome Measures:
- Proportion of subjects with clinical remission as measured by the Crohn's Disease Activity Index [ Time Frame: At 8 weeks during the Induction Period ]
Secondary Outcome Measures:
- Proportion of subjects with clinical response during Induction Period [ Time Frame: Week 8 ]
- Change from baseline of Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 (SF-36) [ Time Frame: Baseline (Week 0), Week 8 and Week 12 ]
- Safety during the Induction Period as measured by adverse events, vital signs, physical examinations and safety lab values [ Time Frame: Up to Week 12 ]
- Immunogenicity during the Induction Period will be assessed based on levels of anti-BMS-945429 antibodies [ Time Frame: Up to Week 12 ]
- Steady-state trough concentration (Cmin) of BMS-945429 during the Induction Period [ Time Frame: Week 4, Week 8, Week 12 ]
- Observed maximum concentration (Cmax) of BMS-945429 during the Induction Period [ Time Frame: Week 0 and Week 4 ]
- Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-945429 during the Induction Period [ Time Frame: Week 0, Week 4, Week 8 ]
| Enrollment: | 72 |
| Study Start Date: | June 2012 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Induction Cohort: Placebo matching with BMS-945429 |
Biological: Placebo matching with BMS-945429
Injection, Intravenous (IV), 0 mg, Day One Only, One Day
Biological: Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
|
| Experimental: Induction Cohort: BMS-945429 (600 IV/200 SC mg) |
Biological: Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
Biological: BMS-945429
Injection, Intravenous (IV), 600 mg, Day One Only, One Day
Biological: BMS-945429
Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
|
| Experimental: Induction Cohort: BMS-945429 (300 IV/100 SC mg) |
Biological: Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
Biological: BMS-945429
Injection, Intravenous (IV), 300 mg, Day One Only, One Day
Biological: BMS-945429
Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
|
| Experimental: Induction Cohort: BMS-945429 (150 IV/100 SC mg) |
Biological: Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
Biological: BMS-945429
Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
Biological: BMS-945429
Injection, Intravenous (IV), 150 mg, Day One Only, One Day
|
| Experimental: Induction Cohort: BMS-945429 (400 SC/200 SC mg) |
Biological: Placebo matching with BMS-945429
Injection, Intravenous (IV), 0 mg, Day One Only, One Day
Biological: BMS-945429
Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
Biological: BMS-945429
Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
|
| Experimental: Maintenance Cohort: Placebo matching with BMS-945429 |
Biological: Placebo matching with BMS-945429
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
|
| Experimental: Maintenance Cohort: BMS-945429 (100 SC mg) |
Biological: BMS-945429
Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
|
| Experimental: Maintenance Cohort: BMS-945429 (200 SC mg) |
Biological: BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
|
| Experimental: Open Label Cohort: BMS-945429 (200 SC mg) |
Biological: BMS-945429
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months
- Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
- Failed conventional therapy or steroid dependent
Exclusion Criteria:
- Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease
- Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
- History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545050
Show 56 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545050
Show 56 Study Locations
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Alder Biopharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01545050 History of Changes |
| Other Study ID Numbers: |
IM133-005 2011-004763-72 ( EudraCT Number ) |
| Study First Received: | March 1, 2012 |
| Last Updated: | July 24, 2015 |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on June 23, 2017