Trial Outcomes & Findings for Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES) (NCT NCT05603754)

Last Updated: 2026-09-01

Results Overview

Evaluate change from baseline OA pain in the target knee as assessed by 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 indicates pain as bad as you can imagine.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

499 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2026-09-01

Participant Flow

Participant milestones

Participant milestones
Measure	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	Vehicle Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Overall Study STARTED	247	252
Overall Study Treated	245	251
Overall Study COMPLETED	232	243
Overall Study NOT COMPLETED	15	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Vehicle Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Overall Study Discontinue before Study Treatment Administration	2	1
Overall Study Adverse Event	0	1
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	2	3
Overall Study Site Terminated by Sponsor	0	1
Overall Study Subject Non-compliance	1	0
Overall Study Withdrawal by Subject for Reason other than lack of efficacy	7	3
Overall Study Subject couldn't complete visit within specified window	2	0

Baseline Characteristics

Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lorecivivint n=242 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	Vehicle n=249 Participants Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle	Total n=491 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=14 Participants	0 Participants n=36 Participants	1 Participants n=324 Participants
Race (NIH/OMB) Black or African American	46 Participants n=14 Participants	45 Participants n=36 Participants	91 Participants n=324 Participants
Race (NIH/OMB) White	188 Participants n=14 Participants	196 Participants n=36 Participants	384 Participants n=324 Participants
Race (NIH/OMB) More than one race	4 Participants n=14 Participants	3 Participants n=36 Participants	7 Participants n=324 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Body Mass Index	29.21 kg / m^2 STANDARD_DEVIATION 3.70 • n=14 Participants	28.87 kg / m^2 STANDARD_DEVIATION 3.82 • n=36 Participants	29.04 kg / m^2 STANDARD_DEVIATION 3.76 • n=324 Participants
Age, Continuous	60.4 years STANDARD_DEVIATION 8.7 • n=14 Participants	61.3 years STANDARD_DEVIATION 9.2 • n=36 Participants	60.9 years STANDARD_DEVIATION 9.0 • n=324 Participants
Sex: Female, Male Female	156 Participants n=14 Participants	154 Participants n=36 Participants	310 Participants n=324 Participants
Sex: Female, Male Male	86 Participants n=14 Participants	95 Participants n=36 Participants	181 Participants n=324 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	158 Participants n=14 Participants	158 Participants n=36 Participants	316 Participants n=324 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=14 Participants	90 Participants n=36 Participants	173 Participants n=324 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants	1 Participants n=36 Participants	2 Participants n=324 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants	0 Participants n=36 Participants	1 Participants n=324 Participants
Race (NIH/OMB) Asian	2 Participants n=14 Participants	5 Participants n=36 Participants	7 Participants n=324 Participants
Kellgren-Lawrence Grade Grade 2	242 Participants n=14 Participants	246 Participants n=36 Participants	488 Participants n=324 Participants
Kellgren-Lawrence Grade Grade 3	0 Participants n=14 Participants	3 Participants n=36 Participants	3 Participants n=324 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: The Full Analysis Set (FAS) includes all subjects who were randomized and received a study injection. 2 subjects from Placebo and 3 from Lorecivivint were excluded from FAS due to duplicate enrollments in current or previous Lorecivivint clinical trials. FAS describes the analysis set which is as complete and as close as possible to the intent-to-treat ideal of including all randomized subjects. Subjects' observed data were analyzed as randomized for the FAS without imputation.

Outcome measures

Outcome measures
Measure	Lorecivivint n=215 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	Vehicle n=227 Participants Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Change From Baseline OA Pain in the Target Knee as Assessed by Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12	-3.64 score on a scale Standard Deviation 2.44	-3.54 score on a scale Standard Deviation 2.45

SECONDARY outcome

Timeframe: Baseline and Week 12

Evaluate change from baseline OA function as assessed by WOMAC Function 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 NRS scale \[0-10\], where 0 indicates no pain / no stiffness / no difficulty, and 10 indicates extreme pain / extreme stiffness / extreme difficulty. For analysis, WOMAC Function scores were scaled to 0 to 100, where 0 represents "No Functional Difficulty" and 100 represents "Extreme Functional Difficulty".

Outcome measures

Outcome measures
Measure	Lorecivivint n=216 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	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
Change From Baseline OA Function as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12	-29.28 score on a scale Standard Deviation 23.45	-28.65 score on a scale Standard Deviation 24.40

SECONDARY outcome

Timeframe: Baseline and Week 12

Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12. The Patient Global Assessment is an 11-point NRS \[0-10\] for subject self-reporting of how they feel their target knee is impacting them. For analysis, PGA scores were scaled to 0 to 100, where 0 represents "Very Good" and 100 represents "Very Bad".

Outcome measures

Outcome measures
Measure	Lorecivivint n=216 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	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
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12	-33.84 score on a scale Standard Deviation 26.55	-33.33 score on a scale Standard Deviation 28.21

POST_HOC outcome

Timeframe: Baseline and Week 12

Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS) for non-Hispanic/Latino subjects. 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

Outcome measures
Measure	Lorecivivint n=76 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	Vehicle n=82 Participants Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Change From Baseline in OA Pain in the Target Knee (Pain NRS) for Sites for Non-Hispanic/Latino Subjects	-3.14 score on a scale Standard Deviation 2.25	-2.51 score on a scale Standard Deviation 2.10

Adverse Events

Lorecivivint

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Vehicle

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lorecivivint n=242 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	Vehicle n=249 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
Cardiac disorders Angina pectoris	0.00% 0/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	0.40% 1/249 • Number of events 1 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	0.40% 1/249 • Number of events 1 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	0.40% 1/249 • Number of events 1 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
General disorders Non-cardiac chest pain	0.41% 1/242 • Number of events 1 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	0.00% 0/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Hepatobiliary disorders Cholecystitis acute	0.41% 1/242 • Number of events 1 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	0.00% 0/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.

Other adverse events

Other adverse events
Measure	Lorecivivint n=242 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	Vehicle n=249 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
Nervous system disorders Headache	6.2% 15/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	4.0% 10/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 7/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	2.4% 6/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Gastrointestinal disorders Diarrhoea	2.9% 7/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	1.2% 3/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Infections and infestations Nasopharyngitis	2.5% 6/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	3.2% 8/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Infections and infestations Influenza	2.1% 5/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	0.00% 0/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.
Musculoskeletal and connective tissue disorders Back pain	1.2% 3/242 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.	4.4% 11/249 • AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination. Safety Analysis Set includes all subjects who received a study injection categorized as treated. 2 subjects from Placebo and 3 from Lorecivivint were excluded from the Safety Analysis Set due to duplicate enrollments in current or previous Lorecivivint clinical trials.

Additional Information

Christopher Swearingen, PhD, VP of Biometrics

Biosplice Therapeutics

Phone: 858.926.2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER