Trial · NCT03706521
MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis
NCT03706521, Phase 2, Terminated, Biosplice Therapeutics, Inc.; results first posted 2026-03-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis. Trials, record NCT03706521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03706521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis
- NCT number
- NCT03706521
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Conditions
- Knee Osteoarthritis
- Interventions
- lorecivivint
- First posted
- 2018-10-16
- Last updated
- 2026-03-04
- Results first posted
- 2026-03-04
- Limitations and caveats
- Given the pilot nature of the study and the impact of COVID-19 pandemic-related issues on data completeness, limited conclusions can be drawn from this study.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Medial Tibial Cartilage Thickness in the Target Knee as Measured by MRI | Baseline and Week 26 | 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. |
| Primary | Change From Baseline in Medial Tibial Cartilage Volume in the Target Knee as Measured by MRI | Baseline and Week 26 | 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. |
| Primary | Change From Baseline in Average T1 Rho for the Medial Tibial Cartilage of Target Knee | Baseline and Week 26 | 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. |
| Primary | Change From Baseline in Average T2 Mapping in Medial Tibial Cartilage of Target Knee | Baseline and Week 26 | 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. |
Source ClinicalTrials.gov
Outcomes4
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 Medial Tibial Cartilage Thickness in the Target Knee as Measured by MRI | Baseline and Week 26 | 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. | millimeters | MEAN |
| PRIMARY | Change From Baseline in Medial Tibial Cartilage Volume in the Target Knee as Measured by MRI | Baseline and Week 26 | 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. | cubic millimeters | MEAN |
| PRIMARY | Change From Baseline in Average T1 Rho for the Medial Tibial Cartilage of Target Knee | Baseline and Week 26 | 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. | milliseconds | MEAN |
| PRIMARY | Change From Baseline in Average T2 Mapping in Medial Tibial Cartilage of Target Knee | Baseline and Week 26 | 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. | milliseconds | MEAN |
Source ClinicalTrials.gov
Results by group4
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 Medial Tibial Cartilage Thickness in the Target Knee as Measured by MRI | Lorecivivint 0.07 mg | 0.15 | Full Range -0.2 to 1 | millimeters | |
| Change From Baseline in Medial Tibial Cartilage Volume in the Target Knee as Measured by MRI | Lorecivivint 0.07 mg | 42.33 | Full Range -146.1 to 415 | cubic millimeters | |
| Change From Baseline in Average T1 Rho for the Medial Tibial Cartilage of Target Knee | Lorecivivint 0.07 mg | 2.345 | Full Range -8.92 to 8.79 | milliseconds | |
| Change From Baseline in Average T2 Mapping in Medial Tibial Cartilage of Target Knee | Lorecivivint 0.07 mg | -0.4 | Full Range -5.48 to 4.85 | milliseconds |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lorecivivint 0.07 mg | 13 | |
| Overall Study | COMPLETED | Lorecivivint 0.07 mg | 7 | |
| Overall Study | NOT COMPLETED | Lorecivivint 0.07 mg | 6 |
Source ClinicalTrials.gov
Adverse events6
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 | Lorecivivint 0.07 mg | 1 | 13 | 1 |
| other | Fall | Injury, poisoning and procedural complications | Lorecivivint 0.07 mg | 1 | 13 | 1 |
| other | Joint lock | Musculoskeletal and connective tissue disorders | Lorecivivint 0.07 mg | 1 | 13 | 1 |
| other | Nasopharyngitis | Infections and infestations | Lorecivivint 0.07 mg | 1 | 13 | 1 |
| other | Tendon rupture | Injury, poisoning and procedural complications | Lorecivivint 0.07 mg | 1 | 13 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Lorecivivint 0.07 mg | 1 | 13 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lorecivivint 0.07 mg | 0 | 13 |
| Total, other adverse events | Lorecivivint 0.07 mg | 4 | 13 |
| Total, serious adverse events | Lorecivivint 0.07 mg | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03706521
GET https://conductscience.org/api/trials/v1/NCT03706521/registered