Trial Outcomes & Findings for 3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis (NCT NCT04931667)
NCT ID: NCT04931667
Last Updated: 2026-03-31
Results Overview
Change from baseline in pain numeric rating scale (NRS) score for the left knee. 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. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
TERMINATED
PHASE3
72 participants
Three Months after Day 1 Injection
2026-03-31
Participant Flow
Participant milestones
| Measure |
0.07 mg Lorecivivint
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
0.07 mg Lorecivivint
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
63
|
|
Overall Study
Withdrawal by Subject
|
7
|
Baseline Characteristics
3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
0.07 mg Lorecivivint
n=72 Participants
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Symptomatic OA Laterality by Investigator Assessment
Bilateral
|
58 Participants
n=4 Participants
|
|
Symptomatic OA Laterality by Investigator Assessment
Unilateral, Right
|
10 Participants
n=4 Participants
|
|
Symptomatic OA Laterality by Investigator Assessment
Unilateral, Left
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Three Months after Day 1 InjectionPopulation: Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized without any imputation for missing data.
Change from baseline in pain numeric rating scale (NRS) score for the left knee. 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. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=13 Participants
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Change From Baseline in Pain Numeric Rating Scale (NRS) Score for the Left Knee
|
-0.9 units on a scale
Interval -6.0 to 4.0
|
PRIMARY outcome
Timeframe: Three Months after Day 1 InjectionPopulation: Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized without any imputation for missing data.
Change from baseline in pain numeric rating scale (NRS) score for the right knee. 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. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=13 Participants
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Change From Baseline in Pain Numeric Rating Scale (NRS) Score for the Right Knee
|
-1.2 units on a scale
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: Three Months after Day 1 InjectionPopulation: Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized.
Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 physical function subscore (WOMAC Function) in left knee. 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, stiffness, and physical functioning of a target joint. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 170 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=13 Participants
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) in Left Knee
|
-13.4 units on a scale
Interval -58.2 to 20.0
|
SECONDARY outcome
Timeframe: Three Months after Day 1 InjectionPopulation: Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized.
Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 physical function subscore (WOMAC Function) in right knee. 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, stiffness, and physical functioning of a target joint. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 170 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=13 Participants
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) in Right Knee
|
-13.5 units on a scale
Interval -46.9 to 5.9
|
SECONDARY outcome
Timeframe: Three Months after Day 1 InjectionPopulation: Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized.
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 pain subscore (WOMAC Pain) in left knee. 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, stiffness, and physical functioning of a target joint. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore ranges from 0 to 50 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=13 Participants
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) in Left Knee
|
-16.8 units on a scale
Interval -56.0 to -16.0
|
SECONDARY outcome
Timeframe: Three Months after Day 1 InjectionPopulation: Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized.
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 pain subscore (WOMAC Pain) in right knee. 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, stiffness, and physical functioning of a target joint. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore ranges from 0 to 50 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=13 Participants
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) in Right Knee
|
-13.7 units on a scale
Interval -36.0 to 8.0
|
Adverse Events
0.07 mg Lorecivivint
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.07 mg Lorecivivint
n=72 participants at risk
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/72 • Number of events 1 • Adverse events were assessed at each in-person and phone visit from the time of study injection(s) on Day 1 through the end of the study (Day 116 / four months duration).
|
|
Infections and infestations
Bacterial Vaginosis
|
1.4%
1/72 • Number of events 1 • Adverse events were assessed at each in-person and phone visit from the time of study injection(s) on Day 1 through the end of the study (Day 116 / four months duration).
|
Additional Information
Christopher Swearingen, PhD, VP of Biometrics
Biosplice Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER