Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

Phase 2

Terminated

• Conditions: Crohn's Disease
• Interventions: Biological: Placebo matching with BMS-945429; Biological: BMS-945429

• Registration Number: NCT01545050
• Lead Sponsor: CSL Behring

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Study Start: 2012-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Disposition First Submitted: 2015-07-24
• Disposition First Submitted QC: 2015-07-24
• Disposition First Posted: 2015-08-13
• Results First Submitted: 2021-10-07
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-06
• Last Update Submitted: 2021-11-06
• Results First Posted: 2021-12-03
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)	BMS-945429	-
Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)	BMS-945429	-
Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)	Placebo matching with BMS-945429	-
Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)	Placebo matching with BMS-945429	-
Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)	Placebo matching with BMS-945429	-
Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg)	BMS-945429	-
Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg)	BMS-945429	-
Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)	Placebo matching with BMS-945429	-
Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)	BMS-945429	-
Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)	Placebo matching with BMS-945429	-
Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)	BMS-945429	-
Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab)	Placebo matching with BMS-945429	-
Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg)	BMS-945429	-

Primary Outcome Measures

Name	Time	Method
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)	At 8 weeks during the Induction Period	CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity

Secondary Outcome Measures

Name	Time	Method
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period	Week 0 and Week 4
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score	Week 8 and Week 12	IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies	Up to Week 12
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI	At 8 weeks during the Induction Period	CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period	Week 4, Week 8
Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period	Week 0, Week 4, Week 8

Trial Locations

Locations (9)

Options Health Research, Llc; 🇺🇸 Tulsa, Oklahoma, United States

Precision Research Institute, Llc; 🇺🇸 San Diego, California, United States

University Of California, San Diego; 🇺🇸 La Jolla, California, United States

Gastro One; 🇺🇸 Germantown, Tennessee, United States

University Of Louisville; 🇺🇸 Louisville, Kentucky, United States

South Denver Gastroenterology, Pc; 🇺🇸 Lone Tree, Colorado, United States

Premier Medical Group Of The Hudson Valley, Pc; 🇺🇸 Poughkeepsie, New York, United States

University Of Florida; 🇺🇸 Gainesville, Florida, United States

Local Institution; 🇬🇧 Harrow, United Kingdom