Trial · NCT04385303
Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
NCT04385303, Phase 3, Completed, Biosplice Therapeutics, Inc.; results first posted 2026-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1). Trials, record NCT04385303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04385303
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
- NCT number
- NCT04385303
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 496 participants, actual
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Conditions
- Knee Osteoarthritis
- Interventions
- Lorecivivint, Placebo
- First posted
- 2020-05-12
- Last updated
- 2026-02-04
- Results first posted
- 2026-02-04
- 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 in the OA-11 trial, which enrolled concurrently, might have confounded short-term therapeutic pain detection; this hypothesis was evaluated in the post-hoc Kellgren-Lawrence Grade 2 only analysis.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Baseline and Week 12 | 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. |
| Secondary | 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 | Baseline and Week 24 | 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. |
| Secondary | 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 | Baseline and Week 12 | 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. |
| Secondary | 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 | Baseline and Week 24 | 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. |
| Secondary | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 | 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 \[0-10\] 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 OA Disease Activity as Assessed by Patient Global Assessment at Week 24 | Baseline and Week 24 | 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". |
Source ClinicalTrials.gov
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline and Week 12 | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline and Week 24 | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline and Week 12 | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline and Week 24 | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 | Baseline and Week 12 | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | units on a scale | MEAN |
| SECONDARY | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24 | Baseline and Week 24 | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | 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 | Baseline and Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | 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 | Baseline and Week 24 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | 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 | Baseline and Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | 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 | Baseline and Week 24 | 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. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Vehicle | -2.15 | Standard Error 0.14 | units on a scale | |
| 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 | Lorecivivint | -2.22 | Standard Error 0.14 | units on a scale | |
| 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 | Vehicle | -2.31 | Standard Error 0.14 | units on a scale | |
| 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 | Lorecivivint | -2.26 | Standard Error 0.14 | units on a scale | |
| 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 | Vehicle | -22.00 | Standard Error 1.42 | units on a scale | |
| 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 | Lorecivivint | -20.29 | Standard Error 1.45 | units on a scale | |
| 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 | Vehicle | -21.91 | Standard Error 1.51 | units on a scale | |
| 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 | Lorecivivint | -20.60 | Standard Error 1.55 | units on a scale | |
| Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 | Vehicle | -22.36 | Standard Error 1.52 | units on a scale | |
| Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 | Lorecivivint | -23.19 | Standard Error 1.56 | units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle | 253 | |
| Overall Study | STARTED | Lorecivivint | 243 | |
| Overall Study | COMPLETED | Vehicle | 233 | |
| Overall Study | COMPLETED | Lorecivivint | 221 | |
| Overall Study | NOT COMPLETED | Vehicle | 20 | |
| Overall Study | NOT COMPLETED | Lorecivivint | 22 |
Source ClinicalTrials.gov
Adverse events22
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 | Urinary tract infection | Infections and infestations | Vehicle | 7 | 251 | 9 |
| other | Urinary tract infection | Infections and infestations | Lorecivivint | 9 | 241 | 13 |
| other | COVID-19 | Infections and infestations | Vehicle | 8 | 251 | 8 |
| other | COVID-19 | Infections and infestations | Lorecivivint | 7 | 241 | 8 |
| other | Hypertension | Vascular disorders | Vehicle | 3 | 251 | 3 |
| other | Hypertension | Vascular disorders | Lorecivivint | 7 | 241 | 7 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Vehicle | 14 | 251 | 16 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Lorecivivint | 7 | 241 | 7 |
| other | Headache | Nervous system disorders | Vehicle | 5 | 251 | 6 |
| other | Headache | Nervous system disorders | Lorecivivint | 2 | 241 | 2 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle | 1 | 251 |
| Total, all-cause mortality | Lorecivivint | 0 | 241 |
| Total, other adverse events | Vehicle | 38 | 251 |
| Total, other adverse events | Lorecivivint | 27 | 241 |
| Total, serious adverse events | Vehicle | 1 | 251 |
| Total, serious adverse events | Lorecivivint | 4 | 241 |
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 |
|---|---|
| Lorecivivint vs Vehicle: deaths from any cause | Trial comparisons |
| 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/NCT04385303
GET https://conductscience.org/api/trials/v1/NCT04385303/results?page=2