Trial · NCT04520607
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
NCT04520607, Phase 3, Terminated, Biosplice Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee. Trials, record NCT04520607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04520607
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
- NCT number
- NCT04520607
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 276 participants, actual
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Conditions
- Osteoarthritis, Knee
- Interventions
- Placebo, Lorecivivint
- First posted
- 2020-08-20
- Last updated
- 2026-03-24
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 OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee | OA-11-study baseline; Visit 3E (Week 48) | Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology. |
| Primary | Change From OA-07-study Baseline OA Pain in the Target Knee | OA-07-study baseline; Visit 2E (Week 24) | Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 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 \[no pain\] to 100 \[pain as bad as it can be\]. |
| Primary | Change From OA-07-study Baseline OA Function in the Target Knee | OA-07-study baseline; Visit 2E (Week 24) | Change from OA-07-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 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 \[highest functional status\] to 100 \[most impaired functional status\]. |
| Secondary | Change From OA-07-study Baseline OA Pain in the Target Knee | OA-07-study baseline; Visit 3E (Week 48) | Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 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 \[no pain\] to 100 \[pain as bad as it can be\]. |
| Secondary | Change From OA-07-study Baseline OA Function in the Target Knee | OA-07-study baseline; Visit 3E (Week 48) | Change from OA-07-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 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 \[highest functional status\] to 100 \[most impaired functional status\]. |
| Other | Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee | OA-11-study baseline; Visit 6E (Week 100) | Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT04520607
GET https://conductscience.org/api/trials/v1/NCT04520607/registered