Trial Outcomes & Findings for Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1) (NCT NCT04385303)
NCT ID: NCT04385303
Last Updated: 2026-02-04
Results Overview
Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
COMPLETED
PHASE3
496 participants
Baseline and Week 12
2026-02-04
Participant Flow
Participant milestones
| Measure |
Vehicle
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
243
|
|
Overall Study
COMPLETED
|
233
|
221
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
Reasons for withdrawal
| Measure |
Vehicle
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Subject Non-Compliance
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
|
Overall Study
Duplicate Subject
|
2
|
1
|
Baseline Characteristics
Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
Baseline characteristics by cohort
| Measure |
Vehicle
n=239 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=231 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
Total
n=470 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 7.9 • n=25 Participants
|
61.0 years
STANDARD_DEVIATION 8.7 • n=26 Participants
|
61.0 years
STANDARD_DEVIATION 8.3 • n=51 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=25 Participants
|
136 Participants
n=26 Participants
|
284 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=25 Participants
|
95 Participants
n=26 Participants
|
186 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=25 Participants
|
60 Participants
n=26 Participants
|
115 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
184 Participants
n=25 Participants
|
171 Participants
n=26 Participants
|
355 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=25 Participants
|
3 Participants
n=26 Participants
|
6 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=25 Participants
|
3 Participants
n=26 Participants
|
6 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=25 Participants
|
3 Participants
n=26 Participants
|
6 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=25 Participants
|
48 Participants
n=26 Participants
|
93 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
181 Participants
n=25 Participants
|
167 Participants
n=26 Participants
|
348 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=25 Participants
|
7 Participants
n=26 Participants
|
11 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Osteoarthritis Symptoms Laterality
Bilateral Symptoms
|
170 Participants
n=25 Participants
|
149 Participants
n=26 Participants
|
319 Participants
n=51 Participants
|
|
Osteoarthritis Symptoms Laterality
Unilateral Symptoms
|
69 Participants
n=25 Participants
|
82 Participants
n=26 Participants
|
151 Participants
n=51 Participants
|
|
Kellgren-Lawrence Grade
Grade 2
|
115 Participants
n=25 Participants
|
111 Participants
n=26 Participants
|
226 Participants
n=51 Participants
|
|
Kellgren-Lawrence Grade
Grade 3
|
124 Participants
n=25 Participants
|
120 Participants
n=26 Participants
|
244 Participants
n=51 Participants
|
|
Medial Joint Space Width
|
2.74 mm
STANDARD_DEVIATION 1.47 • n=25 Participants
|
2.79 mm
STANDARD_DEVIATION 1.57 • n=26 Participants
|
2.77 mm
STANDARD_DEVIATION 1.52 • n=51 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Outcome measures
| Measure |
Vehicle
n=213 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=211 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12
|
-2.15 units on a scale
Standard Error 0.14
|
-2.22 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Outcome measures
| Measure |
Vehicle
n=201 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=185 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24
|
-2.31 units on a scale
Standard Error 0.14
|
-2.26 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Outcome measures
| Measure |
Vehicle
n=222 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=218 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12
|
-22.00 units on a scale
Standard Error 1.42
|
-20.29 units on a scale
Standard Error 1.45
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Outcome measures
| Measure |
Vehicle
n=215 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=202 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24
|
-21.91 units on a scale
Standard Error 1.51
|
-20.60 units on a scale
Standard Error 1.55
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Outcome measures
| Measure |
Vehicle
n=228 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=220 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12
|
-22.36 units on a scale
Standard Error 1.52
|
-23.19 units on a scale
Standard Error 1.56
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 24. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Outcome measures
| Measure |
Vehicle
n=219 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=204 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24
|
-22.18 units on a scale
Standard Error 1.64
|
-23.44 units on a scale
Standard Error 1.69
|
POST_HOC outcome
Timeframe: Baseline and Week 12Population: The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12 in those subjects with Kellgren-Lawrence Grade 2. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Outcome measures
| Measure |
Vehicle
n=94 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=86 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12 in Subjects With Kellgren-Lawrence Grade 2
|
-1.77 units on a scale
Standard Error 0.23
|
-2.30 units on a scale
Standard Error 0.24
|
POST_HOC outcome
Timeframe: Baseline and Week 24Population: The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24 in those subjects with Kellgren-Lawrence Grade 2. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Outcome measures
| Measure |
Vehicle
n=90 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=80 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24 in Subjects With Kellgren-Lawrence Grade 2
|
-1.94 units on a scale
Standard Error 0.25
|
-2.60 units on a scale
Standard Error 0.27
|
POST_HOC outcome
Timeframe: Baseline and Week 12Population: The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 12 in those subjects With Kellgren-Lawrence Grade 2. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Outcome measures
| Measure |
Vehicle
n=93 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=93 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12 in Subjects With Kellgren-Lawrence Grade 2
|
-17.69 units on a scale
Standard Error 2.20
|
-22.94 units on a scale
Standard Error 2.20
|
POST_HOC outcome
Timeframe: Baseline and Week 24Population: The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 24 in those subjects With Kellgren-Lawrence Grade 2. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Outcome measures
| Measure |
Vehicle
n=93 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=89 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24 in Subjects With Kellgren-Lawrence Grade 2
|
-19.76 units on a scale
Standard Error 2.25
|
-23.60 units on a scale
Standard Error 2.30
|
POST_HOC outcome
Timeframe: Baseline and Week 12Population: The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.)
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12 in those subjects with Kellgren-Lawrence Grade 2. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Outcome measures
| Measure |
Vehicle
n=98 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=94 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 in Subjects With Kellgren-Lawrence Grade 2
|
-17.78 units on a scale
Standard Error 2.33
|
-24.76 units on a scale
Standard Error 2.38
|
POST_HOC outcome
Timeframe: Baseline and Week 24Population: The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 24 in those subjects with Kellgren-Lawrence Grade 2. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Outcome measures
| Measure |
Vehicle
n=97 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=89 Participants
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24 in Subjects With Kellgren-Lawrence Grade 2
|
-18.94 units on a scale
Standard Error 2.46
|
-27.33 units on a scale
Standard Error 2.56
|
Adverse Events
Vehicle
Lorecivivint
Serious adverse events
| Measure |
Vehicle
n=251 participants at risk
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=241 participants at risk
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/251 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
0.83%
2/241 • Number of events 2 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/251 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
0.41%
1/241 • Number of events 1 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/251 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
0.41%
1/241 • Number of events 1 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/251 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
0.41%
1/241 • Number of events 1 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.40%
1/251 • Number of events 1 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
0.00%
0/241 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
Other adverse events
| Measure |
Vehicle
n=251 participants at risk
Healthcare professional-administered intra-articular injection; performed on Day 1.
Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
|
Lorecivivint
n=241 participants at risk
Healthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
2.8%
7/251 • Number of events 9 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
3.7%
9/241 • Number of events 13 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Infections and infestations
COVID-19
|
3.2%
8/251 • Number of events 8 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
2.9%
7/241 • Number of events 8 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Vascular disorders
Hypertension
|
1.2%
3/251 • Number of events 3 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
2.9%
7/241 • Number of events 7 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
14/251 • Number of events 16 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
2.9%
7/241 • Number of events 7 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Nervous system disorders
Headache
|
2.0%
5/251 • Number of events 6 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
0.83%
2/241 • Number of events 2 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.4%
6/251 • Number of events 6 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
0.00%
0/241 • AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.
|
Additional Information
Christopher Swearingen, PhD, VP of Biometrics
Biosplice Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER