Trial · NCT03928184
Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis
NCT03928184, Phase 3, Completed, Biosplice Therapeutics, Inc.; results first posted 2026-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis. Trials, record NCT03928184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03928184
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis
- NCT number
- NCT03928184
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 501 participants, actual
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Conditions
- Knee Osteoarthritis
- Interventions
- Lorecivivint, Placebo
- First posted
- 2019-04-26
- Last updated
- 2026-02-13
- Results first posted
- 2026-02-13
- Limitations and caveats
This trial was conducted during COVID-19 and its confounding effects on clinical outcomes in knee OA patients based on observational data have been reported (Knee Surg Sports Traumatol Arthrosc, 2020;28(8):2435-43). Structural progression enrichment, leading to a severely damaged OA population in the OA-11 trial, might have confounded short-term therapeutic pain detection and repeat dosing may be required to demonstrate clinical benefit in severely damaged OA populations.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in OA Pain in the Target Knee (Pain NRS) | 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). 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. |
| Secondary | Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Baseline and Week 24 | Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). 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. |
| Secondary | Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Baseline and Week 52 | Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). 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. |
| Secondary | Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Baseline and Week 12 | Evaluate 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). 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. |
| Secondary | Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Baseline and Week 24 | Evaluate 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). 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. |
| Secondary | Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Baseline and Week 52 | Evaluate 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). 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. |
| Secondary | Change From Baseline in OA Disease Activity (Patient Global Assessment) | Baseline and Week 12 | Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. 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". |
| Secondary | Change From Baseline in OA Disease Activity (Patient Global Assessment) | Baseline and Week 24 | Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. 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". |
| Secondary | Change From Baseline in OA Disease Activity (Patient Global Assessment) | Baseline and Week 52 | Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. 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". |
| Other | Change From Baseline in Medial Joint Space Width (mJSW) in the Target Knee | Baseline and Week 52 | Evaluate change from baseline in mJSW as documented by radiograph of the target knee |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Baseline and Week 12 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Baseline and Week 24 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Baseline and Week 52 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Baseline and Week 12 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Baseline and Week 24 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Baseline and Week 52 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Disease Activity (Patient Global Assessment) | Baseline and Week 12 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Disease Activity (Patient Global Assessment) | Baseline and Week 24 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in OA Disease Activity (Patient Global Assessment) | Baseline and Week 52 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Medial Joint Space Width (mJSW) in the Target Knee | Baseline and Week 52 | Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation. | mm | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in OA Pain in the Target Knee (Pain NRS) | 0.07 mg Lorecivivint | -2.24 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Vehicle | -2.49 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in OA Pain in the Target Knee (Pain NRS) | 0.07 mg Lorecivivint | -2.42 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Vehicle | -2.56 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in OA Pain in the Target Knee (Pain NRS) | 0.07 mg Lorecivivint | -2.31 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in OA Pain in the Target Knee (Pain NRS) | Vehicle | -2.47 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in OA Function in the Target Knee (WOMAC Function) | 0.07 mg Lorecivivint | -21.87 | Standard Error 1.34 | units on a scale | |
| Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Vehicle | -23.67 | Standard Error 1.34 | units on a scale | |
| Change From Baseline in OA Function in the Target Knee (WOMAC Function) | 0.07 mg Lorecivivint | -23.07 | Standard Error 1.42 | units on a scale | |
| Change From Baseline in OA Function in the Target Knee (WOMAC Function) | Vehicle | -23.93 | Standard Error 1.41 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.07 mg Lorecivivint | 248 | |
| Overall Study | STARTED | Vehicle | 253 | |
| Overall Study | Safety Analysis Set | 0.07 mg Lorecivivint | 249 | |
| Overall Study | Safety Analysis Set | Vehicle | 252 | |
| Overall Study | COMPLETED | 0.07 mg Lorecivivint | 224 | |
| Overall Study | COMPLETED | Vehicle | 223 | |
| Overall Study | NOT COMPLETED | 0.07 mg Lorecivivint | 24 | |
| Overall Study | NOT COMPLETED | Vehicle | 30 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 0.07 mg Lorecivivint | 19 | 249 | 21 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Vehicle | 17 | 252 | 19 |
| other | Urinary tract infection | Infections and infestations | 0.07 mg Lorecivivint | 16 | 249 | 17 |
| other | Urinary tract infection | Infections and infestations | Vehicle | 13 | 252 | 13 |
| other | Back pain | Musculoskeletal and connective tissue disorders | 0.07 mg Lorecivivint | 13 | 249 | 14 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Vehicle | 8 | 252 | 10 |
| other | COVID-19 | Infections and infestations | 0.07 mg Lorecivivint | 11 | 249 | 11 |
| other | COVID-19 | Infections and infestations | Vehicle | 7 | 252 | 7 |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | 0.07 mg Lorecivivint | 7 | 249 | 8 |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | Vehicle | 4 | 252 | 4 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.07 mg Lorecivivint | 1 | 249 |
| Total, all-cause mortality | Vehicle | 0 | 252 |
| Total, other adverse events | 0.07 mg Lorecivivint | 85 | 249 |
| Total, other adverse events | Vehicle | 81 | 252 |
| Total, serious adverse events | 0.07 mg Lorecivivint | 12 | 249 |
| Total, serious adverse events | Vehicle | 13 | 252 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39495154 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 0.07 mg Lorecivivint vs Vehicle: deaths from any cause | Trial comparisons |
| 0.07 mg Lorecivivint vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03928184
GET https://conductscience.org/api/trials/v1/NCT03928184/events?page=2