AXER-204 in Participants With Chronic Spinal Cord Injury | NCT03989440 | Trialant
NCT03989440
Sponsor
ReNetX Bio, Inc.
Status
Completed
Last Update Posted
Aug 22, 2023Actual
Enrollment
52Actual
Phase
Phase 1Phase 2
Conditions
Chronic Spinal Cord Injury
Interventions
AXER-204
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03989440
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RNX-AX204-101
Secondary IDs
Not provided
Brief Title
AXER-204 in Participants With Chronic Spinal Cord Injury
Official Title
A Multicenter, Two Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AXER-204 in Subjects With Chronic Spinal Cord Injury
Acronym
RESET
Organization
ReNetX Bio, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 16, 2019Actual
Primary Completion Date
Jun 21, 2022Actual
Completion Date
Jun 21, 2022Actual
First Submitted Date
Jun 11, 2019
First Submission Date that Met QC Criteria
Jun 17, 2019
First Posted Date
Jun 18, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jun 9, 2023
Results First Submitted that Met QC Criteria
Jul 28, 2023
Results First Posted Date
Aug 22, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 28, 2023
Last Update Posted Date
Aug 22, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ReNetX Bio, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
This two-part trial will assess the safety, tolerability, pharmacokinetics, and efficacy of AXER-204 administered by lumbar puncture and slow bolus infusion. Part 1 will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of AXER-204. Part 2 will evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 in comparison to placebo.
Detailed Description
AXER-204 is a human fusion protein that acts as a soluble decoy/trap for the myelin-associated inhibitors of axonal growth known as Nogo-A, MAG, and OMgp. AXER-204 and a surrogate protein used in early preclinical studies have been found to promote axon growth and recovery of function in animal models of spinal cord injury.
Part 1 of the trial is a multicenter, open-label, single ascending dose study in participants with chronic cervical spinal cord injury. Four cohorts of 6 participants each are planned, with participants within each cohort expected to receive the same dose of AXER-204.
Part 2 is a multicenter, randomized, double-blind, placebo-controlled, repeat dose study in chronic cervical spinal cord injury participants. Approximately 32 participants will be randomized (ratio 1:1) to receive repeated doses of AXER-204 or placebo (a phosphate buffered saline formulation). The dose level and dose frequency will be dependent upon outcomes from Part 1.
Conditions Module
Conditions
Chronic Spinal Cord Injury
Keywords
myelin-associated inhibitor
Nogo-A
MAG
OMgp
Nogo Receptor
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
52Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AXER-204
Experimental
Part 1 - Single ascending doses; Part 2 - Repeated dose
Drug: AXER-204
Placebo
Placebo Comparator
Part 2 only - Repeated dose
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AXER-204
Drug
human NoGo Trap fusion protein
AXER-204
human NoGo Trap
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
Up to Day 29 for Part 1 and Day 253 for Part 2
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in Serum
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Cmax in Serum
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Tmax in Serum
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
t1/2 in Serum
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Clearance From Serum
Secondary Outcomes
Measure
Description
Time Frame
Change in International Standards for Neurological Classification of SCI (ISNCSCI) Bilateral Upper Extremity Motor Score (UEMS)
The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate greater strength.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Traumatic spinal cord injury that occurred ≥ 1 year ago
Cervical spinal cord injury with serious neurologic deficit as evidenced by 1) bilateral ISNCSCI UEMS between 4 and 36 points inclusive, and 2) bilateral GRASSP Prehension Ability score between 4 and 17 points inclusive
Confirmation by MRI of the following:
Chronic SCI (persistent spinal cord lesion)
For AIS grade of A without sensory or motor zone of partial preservation extending at least two levels caudal to the level of injury, no apparent transection of the cord
CSF space spanning the lesion
Key Exclusion Criteria:
Penetrating injury to the cord or spinal cord trauma caused by ballistic injury including gunshot that did not penetrate the spinal cord
History of stroke, cerebrovascular injury, or elevated intracranial pressure
Contraindications for lumbar puncture
Requiring mechanical ventilatory assistance of any type
Body mass index (BMI) ≥ 35 kg/m2 or body weight <50 kg
History of life threatening allergic or immune-mediated reaction to vaccines, or biologic drugs, at any time or any life threatening allergic or immune-mediated reaction within the past 12 months
Subjects fitted with an implanted pump or port for delivery of therapeutics to the CSF
Uncontrolled medical condition including but not limited to cardiovascular disease, sleep apnea, obstructive lung disease, severe neuropathic or severe chronic pain, severe autonomic dysreflexia
Participation in any other investigational drug or device trial within 30 days or within 5 half-lives of the investigational drug or any past participation in a SCI cellular therapy trial.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Maynard G, Kannan R, Liu J, Wang W, Lam TKT, Wang X, Adamson C, Hackett C, Schwab JM, Liu C, Leslie DP, Chen D, Marino R, Zafonte R, Flanders A, Block G, Smith E, Strittmatter SM. Soluble Nogo-Receptor-Fc decoy (AXER-204) in patients with chronic cervical spinal cord injury in the USA: a first-in-human and randomised clinical trial. Lancet Neurol. 2023 Aug;22(8):672-684. doi: 10.1016/S1474-4422(23)00215-6.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Part 1: 25 participants were enrolled. One patient was withdrawn from the study prior to dosing and is not included in the Safety Population used for data analyses. Part 2: 27 participants were enrolled.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
FG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
FG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
FG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
FG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
FG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0037 subjects
FG00414 subjects
FG00513 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0025 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
COVID-19 travel restrictions
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
BG001
Part 1 - AXER-204 - 30 mg
Denominators
Units
Counts
Participants
BG000
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
Outcome Measures Module
Outcome Measures
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
Incidence of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
Posted
Count of Participants
Participants
Up to Day 29 for Part 1 and Day 253 for Part 2
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Adverse Events Module
Frequency Threshold
0
Time Frame
Part 1: up to Day 29, Part 2: up to Day 253
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
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
Day 1 pre-dose up to Day 29 in Part 1, Pre-dose up to Day 253 in Part 2
Volume of Distribution
Volume of distribution calculated from serum exposure data
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in CSF
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Cmax of AXER-204 in CSF
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Tmax of AXER-204 in CSF
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
t1/2 of AXER-204 in CSF
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
Baseline to Day 169
Change in Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Bilateral Prehension Performance Score
The GRASSP Bilateral Prehension Performance Score is determined based on performance of four tasks with each hand with scores ranging from 0 to 5 for each task resulting in a maximum score of 40. Higher scores indicate better function.
Baseline to Day 169
Change in Version III of the Spinal Cord Independence Measure (SCIM III) Self-care
The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20 with higher scores correspond to better ability to carry out these self-care activities.
Baseline to Day 169
Patient Global Impression of Change (PGIC) Responder Rate
The PGIC instrument captures the patient's overall evaluation of response to treatment. Specifically, the PGIC asks: "Since beginning this clinical trial, how would you describe the overall change (if any) related to your chronic spinal cord injury?" The patient is asked to report the degree to which they have changed since entering the treatment period using a 7-point Likert scale (1='Much worse', 2='Worse', 3='A little worse', 4='No change', 5='A little better', 6='Better', 7='Much better') and "If better or worse, what has changed?". Patients that have evaluation results including "Much better", "Better", or "A little better" are considered Responders.
Day 169
Atlanta
Georgia
30309
United States
Shirley Ryan AbilityLab / Northwestern
Chicago
Illinois
60611
United States
Spaulding Rehabilitation
Boston
Massachusetts
02129
United States
The Ohio State University Wexner Medical Center
Columbus
Ohio
43210
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
14 subjects
FG00513 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Unsuccessful lumbar puncture
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
BG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
BG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
BG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
BG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
BG006
Total
Total of all reporting groups
6
BG0016
BG0026
BG0036
BG00414
BG00513
BG00651
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG00400
BG0050
BG0060
Between 18 and 65 years
BG0006
BG0016
BG0026
BG0036
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00031.7± 9.1
BG00144.8± 11.5
BG00237.3± 16
BG00341.2± 16.2
BG00441.1± 13.8
BG00534.5± 13.2
BG00638.3± 13.5
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG0021
BG0034
BG0041
BG0053
BG00610
Male
BG0005
BG0016
BG0025
BG0032
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Asian
BG0002
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0011
BG0021
BG0031
BG004
White
BG0003
BG0015
BG0025
BG0035
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0006
BG0016
BG0026
BG0036
BG00414
BG00513
BG00651
International Standards for the Neurological Classification of Spinal Cord Injury, Bilateral Upper E
The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate greater strength.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00024.2± 6.6
BG00126.7± 6.3
BG00228.0± 5.5
BG00328.7± 4.8
BG00426.6± 5.4
BG00523.9± 5.6
BG00626.1± 5.6
Graded Redefined Assessment of Strength, Sensibility, and Prehension; Bilateral Prehension Performan
The GRASSP Bilateral Prehension Performance Score is determined based on performance of four tasks with each hand with scores ranging from 0 to 5 for each task resulting in a maximum score of 40. Higher scores indicate better function.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00016.5± 5.8
BG00121.0± 7.6
BG00218.0± 6.3
BG00316.3± 6.7
BG00416.4± 3.8
BG00518.5± 4.5
BG00617.7± 5.4
Spinal Cord Independence Measure, Version III; Self-care
The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20 with higher scores correspond to better ability to carry out these self-care activities.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0009.8± 5.0
BG0018.5± 4.7
BG00211.5± 2.8
BG00310.3± 3.6
BG00410.4± 5.7
BG00511± 3.6
BG00610.4± 4.4
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG00414
OG00513
Title
Denominators
Categories
Title
Measurements
OG0005
OG0014
OG0025
OG0036
OG00414
OG00510
Primary
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in Serum
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
h*ng/mL
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAll values below limit of quantification
OG001NA± NAQuantifiable concentrations were present in too few of the samples to permit calculation
OG0023670
Primary
Cmax in Serum
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14)
Posted
Mean
Standard Deviation
ng/mL
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAll values below limit of quantification
OG001NA± NAQuantifiable concentrations were present in too few of the samples to permit determination
OG002
Primary
Tmax in Serum
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
hours
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAll values below limit of quantification
OG001NA± NAQuantifiable concentrations were present in too few of the samples to permit determination
OG002
Primary
t1/2 in Serum
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
hours
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAll values below limit of quantification
OG001NA± NAQuantifiable concentrations were present in too few of the samples to permit calculation
OG002NA
Primary
Clearance From Serum
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
L/h
Day 1 pre-dose up to Day 29 in Part 1, Pre-dose up to Day 253 in Part 2
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAll values below limit of quantification
OG001NA± NAQuantifiable concentrations were present in too few of the samples to permit calculation
OG002NA
Primary
Volume of Distribution
Volume of distribution calculated from serum exposure data
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
L
Part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, Day 4, 8, 15, and 29, Part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on Study Days 169 and 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAll values below limit of quantification
OG001NA± NAQuantifiable concentrations were present in too few of the samples to permit calculation
OG002NA
Primary
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of AXER-204 in CSF
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
h*ng/mL
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00057200± 61500
OG0015810000± 12300000
OG00212500000± 18000000
OG003
Primary
Cmax of AXER-204 in CSF
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
ng/mL
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003340± 2890
OG00187900± 128000
OG002280000± 221000
OG003
Primary
Tmax of AXER-204 in CSF
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
h
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00024.2± 0.91
OG00123.9± 0.89
OG00223.2± 0.49
OG003
Primary
t1/2 of AXER-204 in CSF
In Part 2, only pharmacokinetic samples from participants receiving AXER-204 were analyzed (n=14).
Posted
Mean
Standard Deviation
h
Part 1: pre-dose, post-dose at 24 h, 72 h, Days 8 and 29, Part 2: pre-dose on Days 1, 21, 42, 63, and 104, and on Day 253.
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAQuantifiable concentrations were present in too few of the samples to permit calculation
OG00123.1± 32.2
OG00213.5± 10.8
Secondary
Change in International Standards for Neurological Classification of SCI (ISNCSCI) Bilateral Upper Extremity Motor Score (UEMS)
The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate greater strength.
This was pre-specified to be an exploratory outcome in Part 1, and therefore data will not be reported
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline to Day 169
ID
Title
Description
OG000
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG001
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG00014
OG00113
Title
Denominators
Categories
Title
Measurements
OG0002.05(0.59 to 3.52)
OG0011.52(0.021 to 3.01)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.59
LS Mean Difference
0.54
2-Sided
95
-1.48
2.55
Superiority
Secondary
Change in Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Bilateral Prehension Performance Score
The GRASSP Bilateral Prehension Performance Score is determined based on performance of four tasks with each hand with scores ranging from 0 to 5 for each task resulting in a maximum score of 40. Higher scores indicate better function.
This was pre-specified to be an exploratory outcome in Part 1, and therefore data will not be reported
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline to Day 169
ID
Title
Description
OG000
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG001
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG00014
OG00113
Title
Denominators
Categories
Title
Measurements
OG0000.42(-1.07 to 1.91)
OG0011.97(0.41 to 3.54)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.13
LS Mean Difference
-1.56
2-Sided
95
-3.62
0.50
Superiority
Secondary
Change in Version III of the Spinal Cord Independence Measure (SCIM III) Self-care
The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20 with higher scores correspond to better ability to carry out these self-care activities.
This was pre-specified to be an exploratory outcome in Part 1, and therefore data will not be reported
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline to Day 169
ID
Title
Description
OG000
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG001
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG00014
OG00113
Title
Denominators
Categories
Title
Measurements
OG000-0.25(-1.50 to 1.00)
OG0010.91(-0.38 to 2.20)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.16
LS Mean Difference
-1.16
2-Sided
95
-2.81
0.50
Superiority
Secondary
Patient Global Impression of Change (PGIC) Responder Rate
The PGIC instrument captures the patient's overall evaluation of response to treatment. Specifically, the PGIC asks: "Since beginning this clinical trial, how would you describe the overall change (if any) related to your chronic spinal cord injury?" The patient is asked to report the degree to which they have changed since entering the treatment period using a 7-point Likert scale (1='Much worse', 2='Worse', 3='A little worse', 4='No change', 5='A little better', 6='Better', 7='Much better') and "If better or worse, what has changed?". Patients that have evaluation results including "Much better", "Better", or "A little better" are considered Responders.
Posted
Count of Participants
Participants
Day 169
ID
Title
Description
OG000
Part 1 - AXER-204 - 3 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
OG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
OG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
Units
Counts
Participants
OG0006
OG0016
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG000NANot evaluated in Part 1
OG001NANot evaluated in Part 1
OG002NANot evaluated in Part 1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Fisher Exact
0.68
% Difference in responder rate
-9.3
2-Sided
95
-43.3
25.4
Superiority
0
6
0
6
5
6
EG001
Part 1 - AXER-204 - 30 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
0
6
0
6
4
6
EG002
Part 1 - AXER-204 - 90 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
0
6
0
6
5
6
EG003
Part 1 - AXER-204 - 200 mg
Part 1 Open-label single ascending dose. Participants received a single dose of AXER-204. AXER-204: human NoGo Trap fusion protein
0
6
0
6
6
6
EG004
Part 2 - AXER-204 - 200 mg
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. AXER-204: human NoGo Trap fusion protein
0
14
4
14
14
14
EG005
Part 2 - Placebo
Part 2 Double-blind, placebo-controlled repeat dose. Participants received up to 6 doses given approximately every 21 days. Placebo: Phosphate buffered saline formulation
0
13
2
13
10
13
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0052 affected13 at risk
Cellulitis
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Constipation
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Hip fracture
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Headache
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
EG0003 affected6 at risk
EG0011 affected6 at risk
EG0023 affected6 at risk
EG0035 affected6 at risk
EG00413 affected14 at risk
EG0056 affected13 at risk
Paraesthesia
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected6 at risk
EG0032 affected6 at risk
EG0043 affected14 at risk
EG0055 affected13 at risk
Pleocytosis
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0046 affected14 at risk
EG0050 affected13 at risk
Muscle spasticity
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0044 affected14 at risk
EG0051 affected13 at risk
Cerebrospinal fluid leakage
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Neuralgia
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Syncope
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Dizziness
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Hypertonia
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Neurological symptom
Nervous system disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Urinary tract infection
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0046 affected14 at risk
EG0052 affected13 at risk
Cellulitis
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Bacterial disease carrier
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Corona virus infection
Infections and infestations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Constipation
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0051 affected13 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0041 affected14 at risk
EG0052 affected13 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Anal incontinence
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Odynophagia
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Toothache
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0031 affected6 at risk
EG0043 affected14 at risk
EG0054 affected13 at risk
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0042 affected14 at risk
EG0051 affected13 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0042 affected14 at risk
EG0050 affected13 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0051 affected13 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Autonomic dysreflexia
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0053 affected13 at risk
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0051 affected13 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0051 affected13 at risk
Cartilage injury
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Fall
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Scratch
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Stoma site pain
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Procedural headache
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Blood pressure increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0041 affected14 at risk
EG0051 affected13 at risk
CSF protein increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0042 affected14 at risk
EG0050 affected13 at risk
Blood bilirubin increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Body temperature decreased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
CSF white blood cell count increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Haemoglobin decreased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0051 affected13 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Blood blister
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Ingrown hair
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Pyrexia
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected6 at risk
EG0032 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Chills
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0042 affected14 at risk
EG0050 affected13 at risk
Fatigue
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0051 affected13 at risk
Application site irritation
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Axillary pain
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Vaccination site pain
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Asthenia
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Feeling cold
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Feeling hot
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Injection site discomfort
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Puncture site bruise
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Swelling
General disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0050 affected13 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0042 affected14 at risk
EG0051 affected13 at risk
Mental fatigue
Psychiatric disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0042 affected14 at risk
EG0050 affected13 at risk
Attention deficit/hyperactivity disorder
Psychiatric disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected14 at risk
EG0051 affected13 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Hypertensive urgency
Vascular disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
Labile hypertension
Vascular disorders
MedDRA Version 22.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected14 at risk
EG0050 affected13 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PIs are free to publish, present, or use institution specific study data and results arising out of their performance of the protocol. At least forty five (45) days prior to submission for publication, PIs must submit to sponsor for review and comment any proposed oral or written publication. The first publication of the results shall be a joint multi-center publication of the study results managed and coordinated by sponsor unless this is not completed within 18 months after completion date.
14
BG00512
BG00650
0
BG0051
BG0061
13
BG00510
BG00641
1
BG0050
BG0063
0
BG0050
BG0060
1
BG0052
BG0067
12
BG00511
BG00641
0
BG0050
BG0060
0
BG0050
BG0060
6
OG00414
OG0050
± 1520
OG00320900± 7540
OG004NA± NACould not be calculated due to the limited sampling interval
6
OG00414
OG0050
277
± 79.1
OG003641± 173
OG004NA± NACould not be determined due to the limited sampling interval
6
OG00414
OG0050
16.8
± 6.5
OG00312.8± 5.06
OG004NA± NACould not be determined due to the limited sampling interval
6
OG00414
OG0050
± NA
Quantifiable concentrations were present in too few of the samples to permit calculation
OG00353.9± 24.8
OG004NA± NACould not be calculated due to the limited sampling interval
6
OG00414
OG0050
± NA
Quantifiable concentrations were present in too few of the samples to permit calculation
OG0034.84± 1.41
OG004NA± NACould not be calculated due to the limited sampling interval
6
OG00414
OG0050
± NA
Quantifiable concentrations were present in too few of the samples to permit calculation
OG003344± 70.1
OG004NA± NACould not be calculated due to the limited sampling interval
6
OG00414
OG0050
10000000
± 6260000
OG004NA± NACould not be calculated due to the limited sampling interval
6
OG00414
OG0050
412000
± 129000
OG004NA± NACould not be determined due to the limited sampling interval
6
OG00414
OG0050
22.9
± 0.93
OG004NA± NACould not be determined due to the limited sampling interval
6
OG00414
OG0050
OG00312.5± 7.08
OG004NA± NACould not be calculated due to the limited sampling interval