| Primary | Change From Baseline in Peroneal Motor Nerve Conduction Velocity at Week 16 | Peroneal motor nerve conduction velocity was evaluated by electrical stimulation of the nerve and recorded the compound muscle action potential from surface electrodes overlying a muscle supplied by the nerve. Change from baseline in peroneal motor nerve conduction velocity at Week 16 was reported. | The SAF included all randomized participants who received any study drug and was based on the treatment received (as treated). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | m/sec | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.2± 0.46
- OG0010.2± 0.42
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| | 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 |
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| | Mixed Model for Repeated Measures (MMRM) | | 0.4192 | Analyses are based on Mixed Model for Repeated Measures (MMRM) model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction. | Least Square (LS) Mean Difference | 0.4 | | | 2-Sided | 95 | -0.55 | 1.32 | | | | | Superiority | | |
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| Primary | Change From Baseline in Peroneal Motor Nerve Action Potential Amplitude at Week 16 | Peroneal motor nerve action potential amplitude was evaluated at ankle by electrical stimulation of the nerve and recorded the compound muscle action potential from surface electrodes overlying a muscle supplied by the nerve. Change from baseline in peroneal motor nerve action potential amplitude at Week 16 was reported. | SAF included all randomized participants who received any study drug and was based on the treatment received (as treated). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | mV | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Primary | Change From Baseline in Sural Sensory Nerve Conduction Velocity at Week 16 | Sural sensory nerve conduction velocity was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in sural sensory nerve conduction velocity at Week 16 was reported. | SAF included all randomized participants who received any study drug and was based on the treatment received (as treated). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | m/sec | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Primary | Change From Baseline in Sural Sensory Nerve Action Potential Amplitude at Week 16 | Sural sensory nerve action potential amplitude was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in sural sensory nerve action potential amplitude at Week 16 was reported. | SAF included all randomized participants who received any study drug and was based on the treatment received (as treated). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | mcV | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Primary | Change From Baseline in Ulnar Sensory Nerve Conduction Velocity at Week 16 | Ulnar sensory nerve conduction velocity was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in ulnar sensory nerve conduction velocity at Week 16 was reported. | SAF included all randomized participants who received any study drug and was based on the treatment received (as treated). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | m/sec | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Primary | Change From Baseline in Ulnar Sensory Nerve Action Potential Amplitude at Week 16 | Ulnar sensory nerve action potential amplitude was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline ulnar sensory nerve action potential amplitude at Week 16 was reported. | SAF included all randomized participants who received any study drug and was based on the treatment received (as treated). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | mcV | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. A negative change from baseline indicated improvement. Change from baseline in WOMAC Pain subscale score at Week 16 was reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Change From Baseline in WOMAC Physical Function Subscale Score at Week 16 | Physical function referred to subject's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. A negative change from baseline indicated improvement. Change from baseline in WOMAC physical function subscale score at Week 16 was reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | Score on a Scale | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as an AE with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs were reported. | SAF included all randomized participants who received any study drug and was based on the actual treatment received (as treated). | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Number of Adjudicated Arthropathy (AA) Events | AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. Number of confirmed AA events from baseline up to follow-up (Week 36) were reported. | SAF included all randomized participants who received any study drug and was based on the actual treatment received (as treated). | Posted | | Number | | Adjudicated Arthropathy (AA) Events | | Baseline up to follow-up (Week 36) | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Number of AA Events Meeting Destructive Arthropathy (DA) Criteria | AAs were evaluated to determine if they met Destructive Arthropathy (DA) criteria. DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. Number of confirmed AA events meeting DA criteria from baseline up to follow-up (Week 36) were reported. | SAF included all randomized participants who received any study drug and was based on the actual treatment received (as treated). "Overall Number of Participants Analyzed" signifies those participants who had confirmed AA events. | Posted | | Number | | Destructive Arthropathy (DA) Events | | Baseline up to follow-up (Week 36) | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Number of Sympathetic Nervous System (SNS) Dysfunction Events | Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist. Number of SNS dysfunction events from baseline up to follow-up (Week 36) were reported. | SAF included all randomized participants who received any study drug and was based on the actual treatment received (as treated). | Posted | | Number | | SNS Dysfunction Events | | Baseline up to follow-up (Week 36) | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation | Any peripheral sensory AE (for example [e.g.], paraesthesia and hypoaesthesia) that required a neurology consultation. Number of peripheral sensory adverse events from baseline up to follow-up (Week 36) were reported. | SAF included all randomized participants who received any study drug and was based on the actual treatment received (as treated). | Posted | | Number | | Peripheral Sensory Adverse Events (AEs) | | Baseline up to follow-up (Week 36) | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Number of All-Cause Joint Replacement (JR) Surgery Events | All joint replacement surgery events regardless of cause. | SAF included all randomized participants who received any study drug and was based on the actual treatment received (as treated). | Posted | | Number | | Joint Replacement (JR) Surgery Events | | Baseline up to follow-up (Week 36) | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W | Participants received Fasinumab 1 mg SC Q4W from Day 1 through Week 12 of the 16-week treatment period. |
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| Secondary | Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug | An end of study phone contact was conducted approximately 52 weeks following the last dose of study drug (Week 64) to evaluate the number of participants who had undergone or were scheduled for JR surgery. | SAF included all randomized participants who received any study drug and was based on the actual treatment received (as treated). | Posted | | Number | | Joint Replacement (JR) Surgery Events | | Baseline up to EOS (Week 64) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received SC injection of placebo matched to Fasinumab Q4W on Day 1, Weeks 4, 8 and 12. | | OG001 | Fasinumab 1 mg SC Q4W | Subjects received SC injection of Fasinumab at a dose of 1 mg Q4W on Day 1, Weeks 4, 8 and 12. |
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| Secondary | Serum Concentration of Functional Fasinumab | Serum concentrations of functional Fasinumab were reported. | The Pharmacokinetic (PK) Analysis Set included all treated participants who received any study drug and who had at least 1 non-missing drug concentration result following the first dose of study drug. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points. | Posted | | Mean | Standard Deviation | Milligrams per Liter (mg/L) | | Baseline, Week 1, 2, 4, 8, 12, 16 and 36 | | | | ID | Title | Description |
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| OG000 | Fasinumab 1 mg SC Q4W | Subjects received SC injection of Fasinumab at a dose of 1 mg Q4W on Day 1, Weeks 4, 8 and 12. |
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| Secondary | Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) | Samples for ADA evaluation were collected at baseline and at subsequent study visits. ADA variables included ADA status (+/-) and titer as follows: Total participants negative in ADA assay at all time points analyzed. Pre-existing immunoreactivity- positive response at baseline with all post-dose results negative/positive response at baseline with all post-dose responses less than 9-fold over baseline titer levels. Treatment emergent - post-dose positive result when baseline results were negative. Persistent - A positive result detected in at least/ more 2 consecutive post baseline samples separated by at least a 16-week post baseline period, with no negative results in-between. Indeterminate - A positive result at the last collection time point analyzed only. Transient - Not persistent or indeterminate regardless of any missing samples. Treatment boosted- positive response in ADA assay post first dose that is greater than/equal 9-fold over baseline level when baseline is positive. | The anti-drug antibody (ADA) analysis set included all treated participants who received any study drug and had at least 1 qualified (non-missing) ADA result following the first dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to follow-up period (Week 36) | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received Fasinumab-matching placebo SC Q4W from Day 1 through Week 12 of the 16-week treatment period. | | OG001 | Fasinumab 1 mg SC Q4W |
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