Phase 2 Study of BIIB092 in Participants With Early Alzhe... | NCT03352557 | Trialant
NCT03352557
Sponsor
Biogen
Status
Terminated
Last Update Posted
Nov 8, 2022Actual
Enrollment
654Actual
Phase
Phase 2
Conditions
Alzheimer's Disease
Interventions
BIIB092
Placebo
Countries
United States
Australia
France
Germany
Italy
Japan
Poland
Spain
Sweden
Protocol Section
Identification Module
NCT ID
NCT03352557
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
251AD201
Secondary IDs
ID
Type
Description
Link
2017-002901-37
EudraCT Number
Brief Title
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Official Title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease
Acronym
TANGO
Organization
BiogenINDUSTRY
Status Module
Record Verification Date
Oct 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.
Expanded Access Info
No
Start Date
May 3, 2018Actual
Primary Completion Date
Aug 30, 2021Actual
Completion Date
Aug 30, 2021Actual
First Submitted Date
Nov 21, 2017
First Submission Date that Met QC Criteria
Nov 21, 2017
First Posted Date
Nov 24, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 26, 2022
Results First Submitted that Met QC Criteria
Oct 18, 2022
Results First Posted Date
Nov 8, 2022Actual
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
Oct 18, 2022
Last Update Posted Date
Nov 8, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BiogenINDUSTRY
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
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.
The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's Disease
Keywords
Mild cognitive impairment
Alzheimer's disease
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
654Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Low-dose BIIB092
Experimental
Intravenous (IV) infusion once every 4 weeks OR once every 12 weeks and placebo at the other 4-week dosing visits to maintain the treatment blind.
Drug: BIIB092
Medium-dose BIIB092
Experimental
Intravenous (IV) infusion once every 4 weeks.
Drug: BIIB092
High-dose BIIB092
Experimental
Intravenous (IV) infusion once every 4 weeks.
Drug: BIIB092
Placebo
Placebo Comparator
Intravenous (IV) infusion once every 4 weeks.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIIB092
Drug
Administered as specified in treatment arm.
High-dose BIIB092
Low-dose BIIB092
Medium-dose BIIB092
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
LTE Period: Percentage of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a participant 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; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
From Week 80 to Week 173
Secondary Outcomes
Measure
Description
Time Frame
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Must have a gradual and progressive change in memory function over more than 6 months.
Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
Objective evidence of cognitive impairment at Screening
Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
CDR Memory Box score of ≥0.5
Must consent to apolipoprotein E (ApoE) genotyping
Must have 1 informant/study partner
Must have amyloid beta positivity confirmed at Screening
Key Exclusion Criteria:
Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
Indication of impaired renal or liver function
Alcohol or substance abuse in past 1 year
Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
Contraindications to study procedures
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Shulman M, Kong J, O'Gorman J, Ratti E, Rajagovindan R, Viollet L, Huang E, Sharma S, Racine AM, Czerkowicz J, Graham D, Li Y, Hering H, Haeberlein SB. TANGO: a placebo-controlled randomized phase 2 study of efficacy and safety of the anti-tau monoclonal antibody gosuranemab in early Alzheimer's disease. Nat Aging. 2023 Dec;3(12):1591-1601. doi: 10.1038/s43587-023-00523-w. Epub 2023 Nov 27.
A total of 654 participants with Alzheimer's Disease (AD) were enrolled and randomized to receive placebo or BIIB092 125/375/600/2000 milligrams(mg) in Placebo-Controlled (PC) period. Following PC period, 521 participants entered and 516 were dosed in Long-term Extension (LTE) period, and no participants completed the study due to early termination of the study. WBP/G=Withdrawal by Parent/Guardian
Recruitment Details
Participants were enrolled at approximately 100 investigational sites from 03 May 2018 to 30 August 2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PC Period: Placebo
Participants received BIIB092-matching placebo, intravenous (IV) infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
FG002
PC Period: BIIB092 375 mg/12 Week
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
FG003
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
FG004
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
FG005
LTE Period: BIIB092 125 mg/4 Week
Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
FG006
LTE Period: BIIB092 375 mg/12 Week
Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.
FG007
LTE Period: BIIB092 600 mg/4 Week
Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
FG008
LTE Period: BIIB092 2000 mg/4 Week - Early Start
Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
FG009
LTE Period: BIIB092 2000 mg/4 Week - Late Start
Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
FG000214 subjects
FG00158 subjects
FG00258 subjects
FG003106 subjects
FG004218 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Safety Analysis Set
Safety Analysis Set = Dosed Participants
FG000214 subjects
FG00158 subjects
FG00258 subjects
FG003106 subjects
FG004214 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Full Analysis Set (FAS)
FG000214 subjects
FG00158 subjects
FG00258 subjects
FG003106 subjects
FG004214 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Antidrug Antibody (ADA) Evaluable Set
FG000211 subjects
FG00157 subjects
FG00257 subjects
FG003105 subjects
FG004212 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG000172 subjects
FG00148 subjects
FG00250 subjects
FG00391 subjects
FG004175 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG00042 subjects
FG00110 subjects
FG0028 subjects
FG00315 subjects
FG00443 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG00010 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Noncompliance with Study Drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Randomized by Mistake
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Site Terminated by Sponsor
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts
FG0007 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Withdrawal by Participant-Concern About Study Procedures/Perceived Risks
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Withdrawal by Participant-Relocation (Moving or Has Moved)
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
Withdrawal by Participant-Desire for Change in Treatment (Unrelated to Safety)
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Withdrawal by Participant-Other
FG0006 subjects
FG0012 subjects
FG0022 subjects
FG0035 subjects
FG004
WBP/G-Study Visit Burden/Scheduling Conflicts
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
WBP/G-Concern About Study Procedures/Perceived Risks
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
WBP/G-Desire for Change in Treatment (Unrelated to Safety)
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
WBP/G-Other
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision-Unrelated to Safety
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0005 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG004
Not Dosed
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
LTE Period: Week 80 to Week 173
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00546 subjects2 PC completers did not enter LTE.
FG00649 subjects1 PC completer did not enter LTE.
FG00790 subjects1 PC completer did not enter LTE.
FG008169 subjects6 PC completers did not enter LTE.
FG009167 subjects5 PC completers did not enter LTE.
Safety Analysis Set
Safety Analysis Set = Dosed Participants
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Randomized participants included enrolled participants who received a randomization treatment assignment from the Interactive Response Technology (BIIB092 or placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PC Period: Placebo
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
BG001
PC Period: BIIB092 125 mg/4 Week
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
BG002
PC Period: BIIB092 375 mg/12 Week
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
BG003
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
BG004
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000214
BG00158
BG00258
BG003106
BG004218
BG005654
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00069.8± 6.63
BG00170.4± 6.80
BG00270.3± 6.79
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000106
BG00128
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
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
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).
Posted
Number
percentage of participants
Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
ID
Title
Description
OG000
PC Period: Placebo
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
OG001
PC Period: BIIB092 125 mg/4 Week
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
OG002
PC Period: BIIB092 375 mg/12 Week
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
OG003
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
OG004
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
Units
Counts
Participants
OG000214
OG00158
OG00258
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG00084.6
OG00186.2
OG00282.8
OG003
Primary
LTE Period: Percentage of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a participant 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; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).
Posted
Number
percentage of participants
From Week 80 to Week 173
ID
Title
Description
OG000
LTE Period: BIIB092 125 mg/4 Week
Participants who received BIIB092, 125 mg, IV infusion during the PC Period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
OG001
LTE Period: BIIB092 375 mg/12 Week
Participants who received BIIB092, 375 mg, IV infusion during the PC Period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.
Secondary
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
FAS included all randomized participants who received study treatment (BIIB092 or placebo). As pre-specified in study protocol, 125 mg and 375 mg groups were pooled as 'Low dose' group for efficacy analyses.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 78
ID
Title
Description
OG000
PC Period: Placebo
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
OG001
PC Period: BIIB092 Low Dose
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks or BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
Secondary
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
The ADA evaluable set is defined as participants in the FAS who have an evaluable postbaseline ADA sample.
Posted
Number
percentage of participants
Baseline up to Week 76
ID
Title
Description
OG000
PC Period: Placebo
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
OG001
PC Period: BIIB092 125 mg/4 Week
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
OG002
PC Period: BIIB092 375 mg/12 Week
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
OG003
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
Time Frame
From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
Description
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
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
PC Period: Placebo
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
1
214
26
214
121
214
EG001
PC Period: BIIB092 125 mg/4 Week
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
1
58
6
58
39
58
EG002
PC Period: BIIB092 375 mg/12 Week
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
0
58
6
58
38
58
EG003
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
0
106
13
106
68
106
EG004
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
1
214
25
214
139
214
EG005
LTE Period: BIIB092 125 mg/4 Week
Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
2
45
5
45
10
45
EG006
LTE Period: BIIB092 375 mg/12 Week
Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.
0
49
1
49
11
49
EG007
LTE Period: BIIB092 600 mg/4 Week
Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
1
89
9
89
19
89
EG008
LTE Period: BIIB092 2000 mg/4 Week - Early Start
Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
1
168
10
168
28
168
EG009
LTE Period: BIIB092 2000 mg/4 Week - Late Start
Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
1
165
13
165
29
165
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG0030 affected106 at risk
EG0040 affected214 at risk
EG0050 affected45 at risk
EG0060 affected49 at risk
EG0070 affected89 at risk
EG0080 affected168 at risk
EG0090 affected165 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Idiopathic orbital inflammation
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0021 affected58 at risk
EG003
Large intestinal stenosis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Oesophageal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0021 affected58 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Retroperitoneal abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0021 affected58 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected214 at risk
EG0011 affected58 at risk
EG0021 affected58 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0021 affected58 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Bladder cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Breast cancer stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Pancreatic carcinoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0021 affected58 at risk
EG003
Penile squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0021 affected58 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Device dislocation
Product Issues
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0011 affected58 at risk
EG0020 affected58 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0008 affected214 at risk
EG0015 affected58 at risk
EG0021 affected58 at risk
EG0032 affected106 at risk
EG0046 affected214 at risk
EG0050 affected45 at risk
EG0060 affected49 at risk
EG0070 affected89 at risk
EG0080 affected168 at risk
EG0090 affected165 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00012 affected214 at risk
EG00111 affected58 at risk
EG0023 affected58 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00013 affected214 at risk
EG0014 affected58 at risk
EG0022 affected58 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0007 affected214 at risk
EG0011 affected58 at risk
EG0024 affected58 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00022 affected214 at risk
EG0014 affected58 at risk
EG0026 affected58 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected214 at risk
EG0013 affected58 at risk
EG0020 affected58 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00015 affected214 at risk
EG0015 affected58 at risk
EG0023 affected58 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00013 affected214 at risk
EG0015 affected58 at risk
EG0023 affected58 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0010 affected58 at risk
EG0020 affected58 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG00023 affected214 at risk
EG0016 affected58 at risk
EG00211 affected58 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0006 affected214 at risk
EG0010 affected58 at risk
EG0021 affected58 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0011 affected58 at risk
EG0023 affected58 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0004 affected214 at risk
EG0012 affected58 at risk
EG0023 affected58 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected214 at risk
EG0013 affected58 at risk
EG0020 affected58 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG00014 affected214 at risk
EG0016 affected58 at risk
EG0027 affected58 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG00016 affected214 at risk
EG0015 affected58 at risk
EG0023 affected58 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected214 at risk
EG0013 affected58 at risk
EG0020 affected58 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected214 at risk
EG0013 affected58 at risk
EG0020 affected58 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG00013 affected214 at risk
EG0015 affected58 at risk
EG0022 affected58 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG00020 affected214 at risk
EG0011 affected58 at risk
EG0026 affected58 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG00011 affected214 at risk
EG0014 affected58 at risk
EG0022 affected58 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected214 at risk
EG0014 affected58 at risk
EG0020 affected58 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG00013 affected214 at risk
EG0014 affected58 at risk
EG0022 affected58 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected214 at risk
EG0013 affected58 at risk
EG0021 affected58 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected214 at risk
EG0013 affected58 at risk
EG0022 affected58 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected214 at risk
EG0013 affected58 at risk
EG0021 affected58 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected214 at risk
EG0011 affected58 at risk
EG0023 affected58 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected214 at risk
EG0011 affected58 at risk
EG0023 affected58 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG00014 affected214 at risk
EG0015 affected58 at risk
EG0023 affected58 at risk
EG003
The study was terminated based on lack of efficacy following the placebo-controlled period readout.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0075 subjects
FG0083 subjects
FG0093 subjects
Withdrawal by Participant-Relocation (Moving or Has Moved)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
Withdrawal by Participant-Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0094 subjects
WBP/G-Study Visit Burden/Scheduling Conflicts
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
WBP/G-Concern About Study Procedures/Perceived Risks
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
WBP/G-Relocation (Moving or Has Moved)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
WBP/G-Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
FG0091 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0082 subjects
FG0090 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
69.7
± 6.66
BG00469.4± 7.11
BG00569.7± 6.81
26
BG00355
BG004114
BG005329
Male
BG000108
BG00130
BG00232
BG00351
BG004104
BG005325
2
BG0031
BG0049
BG00517
Not Hispanic or Latino
BG000208
BG00153
BG00255
BG003103
BG004208
BG005627
Unknown or Not Reported
BG0003
BG0013
BG0021
BG0032
BG0041
BG00510
0
BG0030
BG0040
BG0051
Asian
BG0005
BG0013
BG0022
BG0036
BG0047
BG00523
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0004
BG0010
BG0021
BG0031
BG0041
BG0057
White
BG000201
BG00153
BG00253
BG00398
BG004206
BG005611
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Unknown or Not Reported
BG0003
BG0012
BG0022
BG0031
BG0044
BG00512
106
OG004214
88.7
OG00488.3
SAEs
Title
Measurements
OG00012.1
OG00110.3
OG00210.3
OG00312.3
OG00411.7
OG002
LTE Period: BIIB092 600 mg/4 Week
Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
OG003
LTE Period: BIIB092 2000 mg/4 Week - Early Start
Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
OG004
LTE Period: BIIB092 2000 mg/4 Week - Late Start
Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
Units
Counts
Participants
OG00045
OG00149
OG00289
OG003168
OG004165
Title
Denominators
Categories
AEs
Title
Measurements
OG00068.9
OG00155.1
OG00258.4
OG00361.3
OG00460.0
SAEs
Title
Measurements
OG00011.1
OG0012.0
OG00210.1
OG003
OG002
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
OG003
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
Units
Counts
Participants
OG000214
OG001116
OG002106
OG003214
Title
Denominators
Categories
Baseline
ParticipantsOG000214
ParticipantsOG001116
ParticipantsOG002106
ParticipantsOG003214
Title
Measurements
OG0003.07± 1.467
OG0012.92± 1.620
OG0023.24± 1.557
OG003
Change at Week 78
ParticipantsOG000170
ParticipantsOG00198
ParticipantsOG00291
ParticipantsOG003174
OG004
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.