Dose Ranging Study of BMS-945429 in Subjects With Moderat... | NCT01545050 | Trialant
NCT01545050
Sponsor
CSL Behring
Status
Terminated
Last Update Posted
Dec 3, 2021Actual
Enrollment
72Actual
Phase
Phase 2
Conditions
Crohn's Disease
Interventions
Placebo matching with BMS-945429
Placebo matching with BMS-945429
Placebo matching with BMS-945429
Placebo matching with BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
BMS-945429
Countries
United States
Austria
Canada
Czechia
France
Germany
Hong Kong
Hungary
India
Israel
Italy
Mexico
Netherlands
Poland
South Korea
Switzerland
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01545050
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM133-005
Secondary IDs
ID
Type
Description
Link
2011-004763-72
EudraCT Number
Brief Title
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
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
Acronym
Not provided
Organization
CSL BehringINDUSTRY
Status Module
Record Verification Date
Nov 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
due to sponsor decision
Expanded Access Info
No
Start Date
Jun 2012
Primary Completion Date
Dec 2013Actual
Completion Date
Dec 2013Actual
First Submitted Date
Mar 1, 2012
First Submission Date that Met QC Criteria
Mar 5, 2012
First Posted Date
Mar 6, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 7, 2021
Results First Submitted that Met QC Criteria
Nov 6, 2021
Results First Posted Date
Dec 3, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 24, 2015
Certification/Extension First Submitted that Passed QC Review
Jul 24, 2015
Certification/Extension First Posted Date
Aug 13, 2015Estimated
Last Update Submitted Date
Nov 6, 2021
Last Update Posted Date
Dec 3, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CSL BehringINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 provided
Conditions Module
Conditions
Crohn's Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
72Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
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
At 8 weeks during the Induction Period
Secondary Outcomes
Measure
Description
Time Frame
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
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
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg)
Clazakizumab
At 8 weeks during the Induction Period
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
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.
Week 8 and Week 12
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
Up to Week 12
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Week 4, Week 8
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
Week 0 and Week 4
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
San Diego
California
92114
United States
South Denver Gastroenterology, Pc
Lone Tree
Colorado
80124
United States
University Of Florida
Gainesville
Florida
32610
United States
University Of Louisville
Louisville
Kentucky
40202
United States
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie
New York
12601
United States
Options Health Research, Llc
Tulsa
Oklahoma
74104
United States
Gastro One
Germantown
Tennessee
38138
United States
Local Institution
Vienna
1090
Austria
Local Institution
Calgary
Alberta
T2N 4Z6
Canada
Local Institution
Vancouver
British Columbia
V6Z 2K5
Canada
Local Institution
Saskatoon
Saskatchewan
S7N 0W8
Canada
Local Institution
Hradec Králové
50012
Czechia
Local Institution
Clermont-Ferrand
63003
France
Local Institution
Lille
59037
France
Local Institution
Nice
06200
France
Local Institution
Pessac
33600
France
Local Institution
Saint-Priest-en-Jarez
42270
France
Local Institution
Düsseldorf
40237
Germany
Local Institution
Frankfurt A. M
60431
Germany
Local Institution
Herne
44623
Germany
Local Institution
Kiel
24105
Germany
Local Institution
Magdeburg
39120
Germany
Local Institution
Münster
48155
Germany
Local Institution
Hong Kong
Hong Kong
Local Institution
Budapest
1136
Hungary
Local Institution
Debrecen
4025
Hungary
Local Institution
Pécs
7623
Hungary
Local Institution
Hyderabad
Andhra Pradesh
500082
India
Local Institution
Mumbai
Maharashtra
400020
India
Local Institution
Ludhiana
141001
India
Local Institution
Mumbai
400 029
India
Local Institution
Pune
411030
India
Local Institution
Jerusalem
91031
Israel
Local Institution
Rehovot
76100
Israel
Local Institution
Tel Aviv
64239
Israel
Local Institution
Florence
50134
Italy
Local Institution
Padova
35128
Italy
Local Institution
Roma
00152
Italy
Local Institution
San Donato Milanese (mi)
20097
Italy
Local Institution
San Giovanni Rotondo (fg)
71013
Italy
Local Institution
Mexico City
Mexico City
14080
Mexico
Local Institution
Monterrey
Nuevo León
64460
Mexico
Local Institution
Nijmegen
6500 HB
Netherlands
Local Institution
Krakow
31-864
Poland
Local Institution
Lodz
90-302
Poland
Local Institution
Wroclaw
50-556
Poland
Local Institution
Wroclaw
53-114
Poland
Local Institution
Seoul
120-752
South Korea
Local Institution
Seoul
135-710
South Korea
Local Institution
Seoul
138-736
South Korea
Local Institution
Zurich
8091
Switzerland
Local Institution
Kaohsiung City
80756
Taiwan
Local Institution
Taipei
100
Taiwan
Local Institution
Hull
Kingston Upon Hull, City of
HU3 2JZ
United Kingdom
Local Institution
Harrow
HA1 2UJ
United Kingdom
FG002
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
FG003
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
FG004
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
FG00018 subjects
FG0019 subjects
FG0029 subjects
FG00318 subjects
FG00418 subjects
COMPLETED
FG00011 subjects
FG0014 subjects
FG0024 subjects
FG0036 subjects
FG0049 subjects
NOT COMPLETED
FG0007 subjects
FG0015 subjects
FG0025 subjects
FG00312 subjects
FG0049 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0042 subjects
Adverse Event
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Discontinued study treatment
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Participant no longer meets study criteria
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Administrative reason by sponsor
FG0004 subjects
FG0012 subjects
FG0023 subjects
FG0035 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
BG001
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
BG002
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
BG003
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
BG004
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00018
BG0019
BG0029
BG00318
BG00418
BG00572
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.1± 11.70
BG00136.3± 14.79
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00014
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
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
modified Intent-to-Treat (mITT) defined as all randomized and treated subjects who had a chance to reach Day 57 by the date of study termination
Posted
Number
percentage of participants
At 8 weeks during the Induction Period
ID
Title
Description
OG000
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
OG001
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG002
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG003
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
OG004
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
Units
Counts
Participants
OG00017
OG0019
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00017.6
OG00133.3
OG0020
OG003
Secondary
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
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
mITT
Posted
Number
percentage of participants
At 8 weeks during the Induction Period
ID
Title
Description
OG000
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
OG001
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG002
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG003
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
Secondary
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
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.
mITT
Posted
Mean
Standard Deviation
score on a scale
Week 8 and Week 12
ID
Title
Description
OG000
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
OG001
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG002
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG003
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
Secondary
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
mITT
Posted
Number
participants
Up to Week 12
ID
Title
Description
OG000
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
OG001
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG002
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG003
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
OG004
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
Secondary
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Due to early termination of the study, only a limited number of PK samples were collected and analyzed.
Posted
Mean
Standard Deviation
ug/mL
Week 4, Week 8
ID
Title
Description
OG000
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG001
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG002
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
OG003
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
Units
Counts
Secondary
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.
Posted
Week 0 and Week 4
ID
Title
Description
OG000
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG001
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG002
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
OG003
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
Units
Counts
Secondary
Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period
The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.
Posted
Week 0, Week 4, Week 8
ID
Title
Description
OG000
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG001
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
OG002
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
OG003
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
Time Frame
Up to 12 weeks per participant
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
0
18
2
18
1
18
EG001
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
0
9
2
9
2
9
EG002
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
1
9
2
9
3
9
EG003
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
0
18
6
18
8
18
EG004
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
0
18
4
18
2
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cronh's disease
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG0032 affected18 at risk
EG0043 affected18 at risk
Anal fistula
Gastrointestinal disorders
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Anorectal disorder
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Peritonitis
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Anal fistula infection
Infections and infestations
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Clostridium difficile infection
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Erysipelas
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Pelvic abscess
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Septic shock
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Myocardial infarction
Cardiac disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pericarditis
Cardiac disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
General physical health deterioration
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site erythema
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0032 affected18 at risk
EG0041 affected18 at risk
Injection site reaction
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Influenza like illness
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Injection site haematoma
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Injection site induration
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Injection site rash
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Erysipelas
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Peritonitis
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Septic shock
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Pruritis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Skin depigmentation
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Insomnia
Nervous system disorders
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Pericarditis
Cardiac disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Dry eye
Eye disorders
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood albumin decreased
Investigations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Monocyte count increased
Investigations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Neutrophil count increased
Investigations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Protein total decreased
Investigations
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
CSL behring
610-878-4000
clinicaltrials@cslbehring.com
ID
Term
D003424
Crohn Disease
Ancestor Terms
ID
Term
D015212
Inflammatory Bowel Diseases
D005759
Gastroenteritis
D005767
Gastrointestinal Diseases
D004066
Digestive System Diseases
D007410
Intestinal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000604955
clazakizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
1 subjects
1 subjects
5 subjects
0
BG0040
BG0050
Between 18 and 65 years
BG00017
BG0019
BG0028
BG00318
BG00417
BG00569
>=65 years
BG0001
BG0010
BG0021
BG0030
BG0041
BG0053
36.2
± 17.29
BG00336.3± 10.96
BG00440.9± 11.48
BG00538.6± 12.53
7
BG00310
BG0049
BG00545
Male
BG0004
BG0014
BG0022
BG0038
BG0049
BG00527
16
OG00416
18.8
OG00412.5
OG004
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
Units
Counts
Participants
OG00017
OG0019
OG0028
OG00316
OG00416
Title
Denominators
Categories
Title
Measurements
OG00029.4
OG00133.3
OG00225.0
OG00331.3
OG00412.5
OG004
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day