A Phase 3 interventional study of Fasinumab and Diclofenac in Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals. Completed at 71 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.
The secondary objectives of the study are:
Key Inclusion Criteria (additional criteria may apply at screening):
Key Exclusion Criteria (additional criteria may apply at screening):
Drug: Fasinumab · Drug: Matching placebo
Other: Diclofenac · Drug: Matching placebo
Other: Celecoxib · Drug: Matching placebo
Drug: Matching placebo
Solution for injection in pre-filled syringe
Also known as: REGN475, MT-5547
NSAID active comparator (capsule)
Also known as: ZORVOLEX
NSAID active comparator (capsule)
Also known as: CELEBREX
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
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.
Time frame: Baseline up to Week 24
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
Physical function referred to participant'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 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
Time frame: Baseline up to Week 24
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo
WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Time frame: Baseline up to Week 24
Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Time frame: Baseline up to Week 24
Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Time frame: Baseline up to Week 24
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
Physical function referred to participant'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 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
Time frame: Baseline up to Week 24
Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Time frame: Baseline up to Week 24
Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale
Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.
Time frame: Baseline up to Week 24
Number of Participants With 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. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Time frame: Baseline up to follow-up period (Week 44)
Number of Participants With AA Events Meeting 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.
Time frame: Baseline up to follow-up period (Week 44)
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. TEAE was defined as an AE with an onset that occurs after receiving 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. Any TEAE included participants with both serious and non-serious TEAEs.
Time frame: Baseline up to follow-up period (Week 44)
Number of Participants With 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.
Time frame: Baseline up to follow-up period (Week 44)
Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)
Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).
Time frame: Baseline up to Week 44
Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24
Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.
Time frame: Baseline up to Week 24
Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44
Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.
Time frame: Baseline up to Week 44
Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)
An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
Time frame: At Week 72
Serum Concentrations of Functional Fasinumab
Time frame: At Weeks 0, 4, 8, 16, 24 and 44
Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development
Immunogenicity was characterized by ADA responses \& titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, \>= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.
Time frame: Baseline up to Week 44
A total of 4531 participants were screened in this study. Out of which, 1650 participants were randomized to 1 of the following arms: Fasinumab (1 milligram \[mg\]), non-steroidal anti-inflammatory drug (NSAIDs), matched placebo, Fasinumab 3 and 6 mg. Screen failure was mostly due to inclusion criteria not met/exclusion criteria met. Eligible participants were randomized to receive placebo matched to Fasinumab/NSAIDs, NSAIDs (Diclofenac and Celecoxib) and Fasinumab 1 mg.
| Milestone | Placebo | NSAIDs | Fasinumab 1 mg | Fasinumab 3 mg | Fasinumab 6 mg |
|---|---|---|---|---|---|
| Started | 308 | 612 | 612 | 59 | 59 |
| Full analysis set (fas) | 308 | 612 | 612 | 0 | 0 |
| Safety analysis set (saf) | 309 | 609 | 609 | 0 | 0 |
| Urgent safety measure set (usms) | 0 | 0 | 0 | 59 | 59 |
| Completed treatment | 218 | 436 | 454 | 0 | 0 |
| Completed | 238 | 471 | 463 | 42 | 42 |
| Not completed | 70 | 141 | 149 | 17 | 17 |
| Withdrew: Protocol violation | 8 | 10 | 5 | 0 | 2 |
| Withdrew: Adverse event | 4 | 20 | 17 | 1 | 0 |
| Withdrew: Lack of efficacy | 17 | 16 | 20 | 0 | 0 |
| Withdrew: Physician decision | 6 | 10 | 6 | 9 | 10 |
| Withdrew: Withdrawal by subject | 26 | 58 | 66 | 3 | 5 |
| Withdrew: Lost to follow-up | 8 | 24 | 35 | 4 | 0 |
| Withdrew: Death | 1 | 2 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 1 | 0 | 0 | 0 |
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.
| Score on a Scale | Placebo | Fasinumab 1 mg |
|---|---|---|
| FAS | -2.21 ± 0.165 | -2.84 ± 0.127 |
| mFAS | -2.01 ± 0.182 | -2.78 ± 0.141 |
Physical function referred to participant'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 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
| Score on a Scale | Placebo | Fasinumab 1 mg |
|---|---|---|
| FAS | -2.02 ± 0.164 | -2.65 ± 0.125 |
| mFAS | -1.80 ± 0.180 | -2.62 ± 0.138 |
WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
| Percentage of Participants | Placebo | Fasinumab 1 mg |
|---|---|---|
| Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo | 48.7 | 59.8 |
The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
| Score on a Scale | Placebo | Fasinumab 1 mg |
|---|---|---|
| Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo | -0.66 ± 0.063 | -0.81 ± 0.047 |
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
| Score on a Scale | NSAIDs | Fasinumab 1 mg |
|---|---|---|
| FAS | -2.60 ± 0.128 | -2.84 ± 0.127 |
| mFAS | -2.48 ± 0.140 | -2.78 ± 0.141 |
Physical function referred to participant'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 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
| Score on a Scale | NSAIDs | Fasinumab 1 mg |
|---|---|---|
| FAS | -2.33 ± 0.127 | -2.65 ± 0.125 |
| mFAS | -2.26 ± 0.140 | -2.62 ± 0.138 |
The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
| Score on a Scale | NSAIDs | Fasinumab 1 mg |
|---|---|---|
| Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs | -0.75 ± 0.048 | -0.81 ± 0.047 |
Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.
| Score on a Scale | Pooled Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale | -1.85 ± 0.130 | -2.13 ± 0.101 | -2.51 ± 0.100 |
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. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
| Participants | Pooled Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants With Adjudicated Arthropathy (AA) Events | 5 | 9 | 34 |
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.
| Participants | Pooled Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria | 0 | 0 | 2 |
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. TEAE was defined as an AE with an onset that occurs after receiving 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. Any TEAE included participants with both serious and non-serious TEAEs.
| Participants | Pooled Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 186 | 406 | 403 |
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.
| Participants | Pooled Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events | 0 | 0 | 0 |
Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).
| Participants | Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs) | 8 | 24 | 31 |
Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.
| Participants | Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24 | 2 | 7 | 3 |
Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.
| Participants | Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44 | 6 | 13 | 10 |
An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
| Participants | Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72) | 11 | 29 | 21 |
| Milligrams per Liter (mg/L) | Fasinumab 1 mg |
|---|---|
| Week 0 | 0.000155 ± 0.002 |
| Week 4 | 0.0469 ± 0.0179 |
| Week 8 | 0.0644 ± 0.0275 |
| Week 16 | 0.0738 ± 0.0380 |
| Week 24 | 0.0713 ± 0.0379 |
| Week 44 | 0.000349 ± 0.00476 |
Immunogenicity was characterized by ADA responses \& titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, \>= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.
| Participants | Placebo | NSAIDs | Fasinumab 1 mg |
|---|---|---|---|
| Pre-Existing Immunoreactivity | 10 | 9 | 15 |
| Treated-Boosted Response | 0 | 0 | 0 |
| Treatment-Emergent Response | 3 | 1 | 4 |
Collected over First dose to week 44. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 1/309 (0.3%) | 20/309 (6.5%) | 121/309 (39.2%) |
| NSAIDs | 3/609 (0.5%) | 45/609 (7.4%) | 263/609 (43.2%) |
| Fasinumab 1mg Q4W | 1/609 (0.2%) | 35/609 (5.7%) | 261/609 (42.9%) |
| Fasinumab 3mg Q4W | 0/58 (0%) | 5/58 (8.6%) | 17/58 (29.3%) |
| Fasinumab 6mg Q8W | 0/59 (0%) | 2/59 (3.4%) | 15/59 (25.4%) |
| Event | Placebo | NSAIDs | Fasinumab 1mg Q4W | Fasinumab 3mg Q4W | Fasinumab 6mg Q8W |
|---|---|---|---|---|---|
| Rapidly progressive osteoarthritisMusculoskeletal and connective tissue disorders | 2/309 | 0/609 | 8/609 | 2/58 | 2/59 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/309 | 1/609 | 0/609 | 1/58 | 0/59 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 3/309 | 6/609 | 1/609 | 1/58 | 0/59 |
| Knee arthroplastySurgical and medical procedures | 1/309 | 4/609 | 2/609 | 1/58 | 0/59 |
| Atrioventricular block completeCardiac disorders | 0/309 | 0/609 | 0/609 | 1/58 | 0/59 |
| Subchondral insufficiency fractureMusculoskeletal and connective tissue disorders | 0/309 | 0/609 | 0/609 | 1/58 | 0/59 |
| Joint arthroplastySurgical and medical procedures | 1/309 | 3/609 | 1/609 | 0/58 | 0/59 |
| Hip arthroplastySurgical and medical procedures | 1/309 | 3/609 | 1/609 | 0/58 | 0/59 |
| Atrial fibrillationCardiac disorders | 1/309 | 2/609 | 0/609 | 0/58 | 0/59 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/309 | 0/609 | 2/609 | 0/58 | 0/59 |
| Event | Placebo | NSAIDs | Fasinumab 1mg Q4W | Fasinumab 3mg Q4W | Fasinumab 6mg Q8W |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 48/309 | 107/609 | 95/609 | 2/58 | 2/59 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 36/309 | 78/609 | 82/609 | 4/58 | 3/59 |
| Urinary tract infectionInfections and infestations | 25/309 | 35/609 | 50/609 | 1/58 | 2/59 |
| Back painMusculoskeletal and connective tissue disorders | 17/309 | 44/609 | 46/609 | 1/58 | 1/59 |
| NasopharyngitisInfections and infestations | 22/309 | 38/609 | 29/609 | 2/58 | 1/59 |
| Upper respiratory tract infectionInfections and infestations | 15/309 | 30/609 | 30/609 | 3/58 | 1/59 |
| Blood creatine phosphokinase increasedInvestigations | 3/309 | 5/609 | 5/609 | 3/58 | 3/59 |
| Muscle strainInjury, poisoning and procedural complications | 0/309 | 4/609 | 6/609 | 3/58 | 1/59 |
| Ligament sprainInjury, poisoning and procedural complications | 2/309 | 4/609 | 5/609 | 0/58 | 3/59 |
| Age, Continuous(Years) | Placebo | NSAIDs | Fasinumab 1 mg | Fasinumab 3 mg | Fasinumab 6 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 62.0 ± 9.30 | 62.3 ± 9.41 | 62.1 ± 9.13 | 62.8 ± 9.38 | 61.5 ± 9.55 | 62.2 ± 9.28 |
| Sex: Female, Male(Participants) | Placebo | NSAIDs | Fasinumab 1 mg | Fasinumab 3 mg | Fasinumab 6 mg | Total |
|---|---|---|---|---|---|---|
| Female | 222 | 418 | 436 | 36 | 34 | 1146 |
| Male | 86 | 194 | 176 | 23 | 25 | 504 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | NSAIDs | Fasinumab 1 mg | Fasinumab 3 mg | Fasinumab 6 mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 20 | 44 | 31 | 5 | 10 | 110 |
| Not Hispanic or Latino | 285 | 568 | 581 | 54 | 49 | 1537 |
| Unknown or Not Reported | 3 | 0 | 0 | 0 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Placebo | NSAIDs | Fasinumab 1 mg | Fasinumab 3 mg | Fasinumab 6 mg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 2 | 0 | 0 | 2 |
| Asian | 33 | 57 | 54 | 8 | 3 | 155 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 | 0 | 0 | 2 |
| Black or African American | 60 | 134 | 132 | 12 | 16 | 354 |
| White | 202 | 396 | 405 | 39 | 40 | 1082 |
| More than one race | 11 | 24 | 18 | 0 | 0 | 53 |
| Unknown or Not Reported | 1 | 1 | 0 | 0 | 0 | 2 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score(Score on a scale) | Placebo | NSAIDs | Fasinumab 1 mg | Fasinumab 3 mg | Fasinumab 6 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 6.42 ± 1.394 | 6.38 ± 1.344 | 6.46 ± 1.321 | 6.43 ± 1.401 | 6.54 ± 1.279 | 6.42 ± 1.344 |
| WOMAC Physical Function Subscale Scores(Score on a scale) | Placebo | NSAIDs | Fasinumab 1 mg | Fasinumab 3 mg | Fasinumab 6 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 6.40 ± 1.495 | 6.32 ± 1.418 | 6.39 ± 1.462 | 6.50 ± 1.350 | 6.34 ± 1.392 | 6.37 ± 1.445 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Regeneron Pharmaceuticals