Osteoarthritis of the Knee, Pain
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy. The secondary objectives of the study are: * To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks * To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks * To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
Interventions
DRUGREGN5069
Intravenous (IV) Dose every 4 weeks (Q4W)
DRUGMatching Placebo
Intravenous (IV) Dose every 4 weeks (QW4)
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Generally in good health at the screening visit * Body mass index (BMI) ≤39 kg/m2 at the screening visit * Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit * Moderate-to-severe pain in the index joint * A history of inadequate pain relief from or intolerance to analgesics used for OA Key
Exclusion criteria
* Diagnosis of systemic diseases that may affect joints * History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader. * Is scheduled for a joint replacement surgery to be performed during the study period * Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit * Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted). * History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy * Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study * History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit Note: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Baseline to Week 12 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score | Week 12 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score | Week 12 | The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). |
| Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score | Week 12 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change From Baseline to Week 12 in WOMAC Total Score | Week 12 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Baseline to Week 36 | An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. Treatment-emergent AEs (TEAEs) are AEs that developed or worsened during the treatment period. |
| Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study | Baseline to Week 36 | Adjudicated arthropathy is an umbrella term referring to Rapidly Progressive Osteoarthritis Type 1 (RPOA-1), Rapidly Progressive Osteoarthritis Type 2 (RPOA-2), subchondral insufficiency fractures (SIF) and osteonecrosis (ON) confirmed by an arthropathy adjudication committee. |
| Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Baseline to Week 36 | Immunogenicity will be characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; 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 in the REG5069 ADA assay post first dose when baseline results = negative or missing. |
| Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score | Week 12 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
Countries
Georgia, Moldova, Poland, Ukraine, United States
Participant flow
Recruitment details
The study was conducted in 5 countries and 12 sites participated in enrollment. It consisted of screening period up to 30 days, followed by a 12-week randomized, double-blind, placebo-controlled treatment period, a 24-week follow-up period, and end-of-study phone call approximately 52 weeks after first dose. Study was terminated after all participants completed the week 36 visits.
Pre-assignment details
A total of 259 participants were randomized in 1:1:1 ratio to receive REGN5069 at 100 mg IV Q4W, REGN5069 at 1000 mg IV Q4W, or matching placebo Q4W. Participants were to receive 3 fixed-dose IV infusions at baseline, week 4, and week 8. 171 participants were randomized to receive REGN5069 (86 participants in the 100 mg Q4W group and 85 in the 1000 mg Q4W group) and 88 were randomized to receive placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo intravenously every 4 weeks (Q4W) | 88 |
| REGN5069 100 mg Q4W Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W) | 86 |
| REGN5069 1000 mg Q4W Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W) | 85 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Sponsor decision | 65 | 66 | 64 |
| Overall Study | Withdrawal by Subject | 5 | 5 | 6 |
Baseline characteristics
| Characteristic | Total | REGN5069 1000 mg Q4W | REGN5069 100 mg Q4W | Placebo |
|---|---|---|---|---|
| Age, Continuous | 64.0 Years STANDARD_DEVIATION 7.98 | 64.7 Years STANDARD_DEVIATION 8.3 | 63.9 Years STANDARD_DEVIATION 7.39 | 63.5 Years STANDARD_DEVIATION 8.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 252 Participants | 83 Participants | 85 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 249 Participants | 81 Participants | 85 Participants | 83 Participants |
| Sex: Female, Male Female | 206 Participants | 68 Participants | 74 Participants | 64 Participants |
| Sex: Female, Male Male | 53 Participants | 17 Participants | 12 Participants | 24 Participants |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score | 6.36 Scores on a scale STANDARD_DEVIATION 1.179 | 6.47 Scores on a scale STANDARD_DEVIATION 1.15 | 6.24 Scores on a scale STANDARD_DEVIATION 1.203 | 6.68 Scores on a scale STANDARD_DEVIATION 1.257 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 85 | 0 / 84 |
| other Total, other adverse events | 48 / 88 | 33 / 85 | 36 / 84 |
| serious Total, serious adverse events | 3 / 88 | 3 / 85 | 0 / 84 |
Outcome results
Primary
Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 12
Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | -2.09 Scores on a scale | Standard Error 0.188 |
| REGN5069 100 mg Q4W | Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | -2.37 Scores on a scale | Standard Error 0.191 |
| REGN5069 1000 mg Q4W | Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | -1.98 Scores on a scale | Standard Error 0.19 |
p-value: 0.2978Mixed Models Analysis
p-value: 0.689Mixed Models Analysis
Secondary
Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Time frame: Week 12
Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score | -0.59 Scores on a scale | Standard Error 0.076 |
| REGN5069 100 mg Q4W | Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score | -0.75 Scores on a scale | Standard Error 0.078 |
| REGN5069 1000 mg Q4W | Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score | -0.80 Scores on a scale | Standard Error 0.078 |
p-value: 0.1365Mixed Models Analysis
p-value: 0.0604Mixed Models Analysis
Secondary
Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Week 12
Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score | -1.74 Scores on a scale | Standard Error 0.18 |
| REGN5069 100 mg Q4W | Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score | -2.09 Scores on a scale | Standard Error 0.183 |
| REGN5069 1000 mg Q4W | Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score | -1.75 Scores on a scale | Standard Error 0.182 |
p-value: 0.1597Mixed Models Analysis
p-value: 0.9719Mixed Models Analysis
Secondary
Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Week 12
Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score | -1.70 Scores on a scale | Standard Error 0.214 |
| REGN5069 100 mg Q4W | Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score | -2.20 Scores on a scale | Standard Error 0.217 |
| REGN5069 1000 mg Q4W | Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score | -1.88 Scores on a scale | Standard Error 0.217 |
p-value: 0.0989Mixed Models Analysis
p-value: 0.5487Mixed Models Analysis
Secondary
Change From Baseline to Week 12 in WOMAC Total Score
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Week 12
Population: Full analysis set population (FAS): included all randomized participants; Here number analyzed = number of evaluable participants at this time interval
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in WOMAC Total Score | -1.83 Scores on a scale | Standard Error 0.177 |
| REGN5069 100 mg Q4W | Change From Baseline to Week 12 in WOMAC Total Score | -2.15 Scores on a scale | Standard Error 0.179 |
| REGN5069 1000 mg Q4W | Change From Baseline to Week 12 in WOMAC Total Score | -1.81 Scores on a scale | Standard Error 0.181 |
p-value: 0.1973Mixed Models Analysis
p-value: 0.942Mixed Models Analysis
Secondary
Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study
Adjudicated arthropathy is an umbrella term referring to Rapidly Progressive Osteoarthritis Type 1 (RPOA-1), Rapidly Progressive Osteoarthritis Type 2 (RPOA-2), subchondral insufficiency fractures (SIF) and osteonecrosis (ON) confirmed by an arthropathy adjudication committee.
Time frame: Baseline to Week 36
Population: Safety Analysis Set (SAF): included all randomized participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study | Baseline Up to and Including Week 12 Visit | 1 Events |
| Placebo | Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study | After Week 12 Visit, Up to and Including Week 36 | 0 Events |
| REGN5069 100 mg Q4W | Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study | Baseline Up to and Including Week 12 Visit | 0 Events |
| REGN5069 100 mg Q4W | Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study | After Week 12 Visit, Up to and Including Week 36 | 0 Events |
| REGN5069 1000 mg Q4W | Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study | Baseline Up to and Including Week 12 Visit | 0 Events |
| REGN5069 1000 mg Q4W | Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study | After Week 12 Visit, Up to and Including Week 36 | 0 Events |
Secondary
Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. Treatment-emergent AEs (TEAEs) are AEs that developed or worsened during the treatment period.
Time frame: Baseline to Week 36
Population: Safety Analysis Set (SAF): included all randomized participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Non-Serious TEAEs | 78 Events |
| Placebo | Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Serious TEAEs | 0 Events |
| REGN5069 100 mg Q4W | Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Non-Serious TEAEs | 42 Events |
| REGN5069 100 mg Q4W | Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Serious TEAEs | 2 Events |
| REGN5069 1000 mg Q4W | Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Non-Serious TEAEs | 55 Events |
| REGN5069 1000 mg Q4W | Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study | Serious TEAEs | 0 Events |
Secondary
Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study
Immunogenicity will be characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; 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 in the REG5069 ADA assay post first dose when baseline results = negative or missing.
Time frame: Baseline to Week 36
Population: Anti-Drug Antibody (ADA) Analysis Set: included all treated participants who received any amount of study drug (active or placebo \[safety analysis set (SAF)\]) and had at least one non-missing anti-REGN5069 antibody result following the first dose of study drug or placebo. ADA analysis set is based on actual treatment received, rather than randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Treatment-Emergent Response | 1 Participants |
| Placebo | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Negative | 82 Participants |
| Placebo | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Pre-Existing Immunoreactivity | 1 Participants |
| Placebo | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Treatment-Boosted Response | 0 Participants |
| REGN5069 100 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Treatment-Boosted Response | 0 Participants |
| REGN5069 100 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Treatment-Emergent Response | 0 Participants |
| REGN5069 100 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Pre-Existing Immunoreactivity | 0 Participants |
| REGN5069 100 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Negative | 83 Participants |
| REGN5069 1000 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Treatment-Boosted Response | 0 Participants |
| REGN5069 1000 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Negative | 78 Participants |
| REGN5069 1000 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Pre-Existing Immunoreactivity | 4 Participants |
| REGN5069 1000 mg Q4W | Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study | Treatment-Emergent Response | 0 Participants |
Secondary
Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Week 12
Population: Full analysis set population (FAS): included all randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score | 51.1 Percentage of participants |
| REGN5069 100 mg Q4W | Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score | 58.1 Percentage of participants |
| REGN5069 1000 mg Q4W | Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score | 47.1 Percentage of participants |
p-value: 0.3572Cochran-Mantel-Haenszel
p-value: 0.5747Cochran-Mantel-Haenszel