Trial Outcomes & Findings for MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis (NCT NCT03706521)
NCT ID: NCT03706521
Last Updated: 2026-03-04
Results Overview
The assessment of hyaline cartilage thickness present in the knee joint can be useful in evaluating cartilage health. Cartilage thickness decreases may indicate knee osteoarthritis progression. Cartilage thickness was measured using a semi-automated Local-Area Cartilage Segmentation (LACS) software for knee cartilage segmentation of knee MRI. The LACS coordinate system is based on anatomical bony landmarks and permits measurement within any subregion of the femorotibial joint consistently across longitudinal assessments.
TERMINATED
PHASE2
13 participants
Baseline and Week 26
2026-03-04
Participant Flow
Participant milestones
| Measure |
Lorecivivint 0.07 mg
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Lorecivivint 0.07 mg
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study Closure
|
2
|
Baseline Characteristics
MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Lorecivivint 0.07 mg
n=13 Participants
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=41 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.5 • n=41 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Given the impact of COVID-19 on data completeness, those subjects that were able to be measured are reported. Formal efficacy analyses were not performed due to the early termination of the study (administrative reasons). No formal Statistical Analysis Plan was prepared, and the clinical study report was finalized without completing any statistical analysis.
The assessment of hyaline cartilage thickness present in the knee joint can be useful in evaluating cartilage health. Cartilage thickness decreases may indicate knee osteoarthritis progression. Cartilage thickness was measured using a semi-automated Local-Area Cartilage Segmentation (LACS) software for knee cartilage segmentation of knee MRI. The LACS coordinate system is based on anatomical bony landmarks and permits measurement within any subregion of the femorotibial joint consistently across longitudinal assessments.
Outcome measures
| Measure |
Lorecivivint 0.07 mg
n=6 Participants
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Change From Baseline in Medial Tibial Cartilage Thickness in the Target Knee as Measured by MRI
|
0.15 millimeters
Interval -0.2 to 1.0
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Given the impact of COVID-19 on data completeness, those subjects that were able to be measured are reported. Formal efficacy analyses were not performed due to the early termination of the study (administrative reasons). No formal Statistical Analysis Plan was prepared, and the clinical study report was finalized without completing any statistical analysis.
The assessment of hyaline cartilage volume present in the knee joint can be useful in evaluating cartilage health. Cartilage volume decreases may indicate knee osteoarthritis progression. Cartilage volume was measured using a semi-automated Local-Area Cartilage Segmentation (LACS) software for knee cartilage segmentation of knee MRI. The LACS coordinate system is based on anatomical bony landmarks and permits measurement within any subregion of the femorotibial joint consistently across longitudinal assessments.
Outcome measures
| Measure |
Lorecivivint 0.07 mg
n=6 Participants
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Change From Baseline in Medial Tibial Cartilage Volume in the Target Knee as Measured by MRI
|
42.33 cubic millimeters
Interval -146.1 to 415.0
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Given the impact of COVID-19 on data completeness, those subjects that were able to be measured are reported. Formal efficacy analyses were not performed due to the early termination of the study (administrative reasons). No formal Statistical Analysis Plan was prepared, and the clinical study report was finalized without completing any statistical analysis.
T1rho mapping refers to an investigational magnetic resonance imaging technique that measures the low-frequency interactions between macromolecules such as proteoglycan and glycosaminoglycan and water, useful for evaluating cartilage health. Increase in T1rho measurements over time can represent cartilage degeneration.
Outcome measures
| Measure |
Lorecivivint 0.07 mg
n=6 Participants
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Change From Baseline in Average T1 Rho for the Medial Tibial Cartilage of Target Knee
|
2.345 milliseconds
Interval -8.92 to 8.79
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Given the impact of COVID-19 on data completeness, those subjects that were able to be measured are reported. Formal efficacy analyses were not performed due to the early termination of the study (administrative reasons). No formal Statistical Analysis Plan was prepared, and the clinical study report was finalized without completing any statistical analysis.
T2 mapping refers to an investigational magnetic resonance imaging technique that measures biochemical changes in cartilage, including the integrity of collagen network, and collagen and water content, useful for evaluating cartilage health. Increase in T2 mapping measurements over time can represent cartilage degeneration.
Outcome measures
| Measure |
Lorecivivint 0.07 mg
n=6 Participants
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Change From Baseline in Average T2 Mapping in Medial Tibial Cartilage of Target Knee
|
-0.4 milliseconds
Interval -5.48 to 4.85
|
Adverse Events
Lorecivivint 0.07 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lorecivivint 0.07 mg
n=13 participants at risk
Single intra-articular injection of lorecivivint (SM04690) 0.07 mg in 2 mL vehicle
lorecivivint: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed at each in-person visit and phone contact from the time of study injection on Day 1 through the Week 52 (end of study).
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed at each in-person visit and phone contact from the time of study injection on Day 1 through the Week 52 (end of study).
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed at each in-person visit and phone contact from the time of study injection on Day 1 through the Week 52 (end of study).
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed at each in-person visit and phone contact from the time of study injection on Day 1 through the Week 52 (end of study).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed at each in-person visit and phone contact from the time of study injection on Day 1 through the Week 52 (end of study).
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed at each in-person visit and phone contact from the time of study injection on Day 1 through the Week 52 (end of study).
|
Additional Information
Christopher Swearingen, PhD, VP of Biometrics
Biosplice Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place