Trial · NCT03122860
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
NCT03122860, Phase 2, Completed, Biosplice Therapeutics, Inc.; results first posted 2021-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis. Trials, record NCT03122860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03122860
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
- NCT number
- NCT03122860
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 700 participants, actual
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Conditions
- Knee Osteoarthritis
- Interventions
- SM04690, Placebo, Sham
- First posted
- 2017-04-21
- Last updated
- 2021-06-11
- Results first posted
- 2021-05-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | Baseline and Week 24 | 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 (pain as bad as one can imagine). |
| Primary | Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) | Baseline and Week 24 | Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 24. 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 is standardized and reported ranging from 0 to 100 \[0 = no pain; 100 = pain as bad as it can be\]. |
| Primary | Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function) | Baseline and Week 24 | Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 24. 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 is standardized and reported ranging from 0 to 100 \[0 = no functional disability, 100 = unable to function\]. |
| Primary | Change From Baseline in Medial Joint Space Width (mJSW) of the Target Knee | Baseline and Week 24 | Change from baseline in mJSW as documented by radiograph of the target knee. |
| Secondary | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA) | Baseline and Week 24 | Change from baseline OA disease activity as assessed by PtGA at Week 24. The PtGA was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject. |
| Other | Change From Baseline OA Pain in the Target Knee as Assessed by WOMAC Pain Subscore (WOMAC Pain) | Baseline and Week 12 | Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 12. 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 is standardized and reported ranging from 0 to 100 \[0 = no pain, 100 = pain as bad as it can be\]. |
| Other | Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function) | Baseline and Week 12 | Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 12. 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 is standardized and reported ranging from 0 to 100 \[0 = no functional disability, 100 = unable to function\]. |
| Other | Change From Baseline OA Pain in the Target Knee as Assesses by the Weekly Average of Daily Pain NRS | Baseline and Week 12 | 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 (pain as bad as one can imagine). |
| Other | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA) | Baseline and Week 12 | Change from baseline OA disease activity as assessed by PtGA at Week 12. The PtGA completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | Baseline and Week 24 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | score on a scale | MEAN |
| PRIMARY | Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) | Baseline and Week 24 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | score on a scale | MEAN |
| PRIMARY | Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function) | Baseline and Week 24 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Medial Joint Space Width (mJSW) of the Target Knee | Baseline and Week 24 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | mm | MEAN |
| SECONDARY | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA) | Baseline and Week 24 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | mm | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline OA Pain in the Target Knee as Assessed by WOMAC Pain Subscore (WOMAC Pain) | Baseline and Week 12 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function) | Baseline and Week 12 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline OA Pain in the Target Knee as Assesses by the Weekly Average of Daily Pain NRS | Baseline and Week 12 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA) | Baseline and Week 12 | Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | 0.03 mg SM04690 | -2.77 | Standard Deviation 2.44 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | 0.07 mg SM04690 | -2.93 | Standard Deviation 2.21 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | 0.15 mg SM04690 | -2.43 | Standard Deviation 2.18 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | 0.23 mg SM04690 | -3.03 | Standard Deviation 2.43 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | Placebo | -2.26 | Standard Deviation 2.44 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) | Sham | -2.21 | Standard Deviation 2.46 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) | 0.03 mg SM04690 | -27.6 | Standard Error 22.8 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) | 0.07 mg SM04690 | -30.0 | Standard Error 22.5 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) | 0.15 mg SM04690 | -24.7 | Standard Error 21.6 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) | 0.23 mg SM04690 | -33.3 | Standard Error 22.9 | score on a scale |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.03 mg SM04690 | 117 | |
| Overall Study | STARTED | 0.07 mg SM04690 | 116 | |
| Overall Study | STARTED | 0.15 mg SM04690 | 117 | |
| Overall Study | STARTED | 0.23 mg SM04690 | 116 | |
| Overall Study | STARTED | Placebo | 117 | |
| Overall Study | STARTED | Sham | 117 | |
| Overall Study | Full Analysis Set | 0.03 mg SM04690 | 116 | |
| Overall Study | Full Analysis Set | 0.07 mg SM04690 | 115 | |
| Overall Study | Full Analysis Set | 0.15 mg SM04690 | 115 | |
| Overall Study | Full Analysis Set | 0.23 mg SM04690 | 116 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events210
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 | Abdominal tenderness | Gastrointestinal disorders | 0.03 mg SM04690 | 0 | 106 | 0 |
| other | Abdominal tenderness | Gastrointestinal disorders | 0.07 mg SM04690 | 0 | 104 | 0 |
| other | Abdominal tenderness | Gastrointestinal disorders | 0.15 mg SM04690 | 0 | 106 | 0 |
| other | Abdominal tenderness | Gastrointestinal disorders | 0.23 mg SM04690 | 1 | 106 | 1 |
| other | Abdominal tenderness | Gastrointestinal disorders | Placebo | 0 | 114 | 0 |
| other | Abdominal tenderness | Gastrointestinal disorders | Sham | 0 | 120 | 0 |
| other | Abdominal tenderness | Gastrointestinal disorders | Other | 1 | 39 | 1 |
| other | Nausea | Gastrointestinal disorders | 0.03 mg SM04690 | 0 | 106 | 0 |
| other | Nausea | Gastrointestinal disorders | 0.07 mg SM04690 | 1 | 104 | 1 |
| other | Nausea | Gastrointestinal disorders | 0.15 mg SM04690 | 0 | 106 | 0 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.03 mg SM04690 | 0 | 106 |
| Total, all-cause mortality | 0.07 mg SM04690 | 0 | 104 |
| Total, all-cause mortality | 0.15 mg SM04690 | 0 | 106 |
| Total, all-cause mortality | 0.23 mg SM04690 | 0 | 106 |
| Total, all-cause mortality | Placebo | 0 | 114 |
| Total, all-cause mortality | Sham | 0 | 120 |
| Total, all-cause mortality | Other | 0 | 39 |
| Total, other adverse events | 0.03 mg SM04690 | 14 | 106 |
| Total, other adverse events | 0.07 mg SM04690 | 19 | 104 |
| Total, other adverse events | 0.15 mg SM04690 | 14 | 106 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT03122860
GET https://conductscience.org/api/trials/v1/NCT03122860/results?page=2