| Primary | Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score | Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. | Number of Participants analyzed = Participants evaluable for this endpoint | Posted | | Mean | Standard Deviation | Score on a Scale | | Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
| | | Title | Denominators | Categories |
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| Change from Baseline to Week 1 | - ParticipantsOG00032
- ParticipantsOG00131
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| Secondary | Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score | The RMDQ is a self-administered, health status measure for lower back pain (LBP). It measures pain and function using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores are indicative of better function. | Number of Participants Analyzed = Participants evaluable for this endpoint | Posted | | Mean | Standard Deviation | Score on a Scale | | Week 2, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score | The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 1-5 where 1 = very well; 2 = well; 3 = fair; 4 = poor; and 5 = very poor. | Number of Participants Analyzed = Participants evaluable for this endpoint | Posted | | Mean | Standard Deviation | Score on a Scale | | Week 2, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score | Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. | | Posted | | Count of Participants | | Participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score | The BPI-sf is a self-administered questionnaire for participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. With a recall period of 24 hours, the questionnaire contains the front and back body diagrams, the 4 pain severity items and 7 pain interference items rated on 0-10 scale; total interference score ranges from 0-10 (0, does not interfere; 10 completely interferes), and the question about percentage of pain relief by analgesics. The BPI pain interference is typically scored as the mean of the 7 interference items. | Number of Participants Analyzed = Participants evaluable for this endpoint | Posted | | Mean | Standard Deviation | Score on a Scale | | Week 2, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of Adjudicated Arthropathy (AA) Events | Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria. | | Posted | | Number | | Adjudicated Arthropathy (AA) Events | | Up to Week 36 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria | Destructive arthropathy (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 Osteoarthritis type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis. | | Posted | | Number | | Destructive Arthropathy (DA) Events | | Up to Week 36 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. | | Posted | | Number | | Treatment-Emergent Adverse Events | | Up to Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of Sympathetic Nervous System (SNS) Dysfunction Events | Potential events of sympathetic nervous system (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. | | Posted | | Number | | Sympathetic NS Dysfunction Events | | Up to Week 36 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation | Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that required a neurology consultation. | | Posted | | Number | | Peripheral Sensory Adverse Events (AEs) | | Up to Week 36 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of All-Cause Joint Replacement (JR) Surgery Events | All joint replacement surgery events regardless of cause. | | Posted | | Number | | Joint Replacement (JR) Surgery Events | | Up to Week 36 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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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 12) to evaluate the number of participants who had undergone or were scheduled for JR surgery. | | Posted | | Number | | Joint Replacement (JR) Surgery Events | | Up to Week 64 | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. | | OG001 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay | Samples for Anti-Drug Antibody (ADA) evaluation were collected at baseline and at subsequent study visits. ADA variables include ADA status (+ or -) and titer as follows: Total participants negative in the ADA assay at all time points analyzed. Pre-existing immunoreactivity - positive response at baseline with all post-dose results negative, or a 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 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 - any post-dose positive result at least 9-fold over the baseline level when baseline is positive. | Anti-Drug Antibody (ADA) analysis set: All treated participants who received any study drug or placebo (safety analysis set) and had at least one non-missing anti-drug antibody result following the first dose of study drug or placebo | Posted | | Count of Participants | | Participants | | 16 Weeks | | | | ID | Title | Description |
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| OG000 | Fasinumab-matching Placebo | Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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| Secondary | Serum Concentration of Functional Fasinumab Over Time | Summary of mean concentration of functional fasinumab are presented by nominal time point. | Number of Participants Analyzed = Participants evaluable for this endpoint | Posted | | Mean | Standard Deviation | Milligram per Liter (mg/L) | | Baseline, Week 2, Week 4, Week 8, Week 16 | | | | ID | Title | Description |
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| OG000 | Fasinumab 3 mg SC Q4W | Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks. |
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