Trial · NCT02536833
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
NCT02536833, Phase 2, Completed, Biosplice Therapeutics, Inc.; results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects. Trials, record NCT02536833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02536833
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
- NCT number
- NCT02536833
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 455 participants, actual
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Conditions
- Osteoarthritis
- Interventions
- SM04690, Placebo
- First posted
- 2015-09-01
- Last updated
- 2021-03-17
- Results first posted
- 2020-09-16
Source ClinicalTrials.gov
Registered outcomes13
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 | Baseline and Week 13 | Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. 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 reported ranging from 0 to 100. |
| Secondary | Change From Baseline OA Pain in the Target Knee | Baseline and Week 26 | Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 26. 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 reported ranging from 0 to 100. |
| Secondary | Change From Baseline OA Function in the Target Knee | Baseline and Week 13 | Change from 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) at Week 13. 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 reported ranging from 0 to 100. |
| Secondary | Change From Baseline OA Function in the Target Knee | Baseline and Week 26 | Change from 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) at Week 26. 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 reported ranging from 0 to 100. |
| Secondary | Change From Baseline OA Disease Activity as Assessed by the Patient | Baseline and Week 13 | Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 13. The Patient Global Assessment 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. |
| Secondary | Change From Baseline OA Disease Activity as Assessed by the Patient | Baseline and Week 26 | Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 26. The Patient Global Assessment 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. |
| Secondary | Change From Baseline in Medial Joint Space Width of Target Knee | Baseline and Week 26 | Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 26. |
| Other | Change From Baseline OA Pain in the Target Knee | Baseline and Week 52 | Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 52. 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 reported ranging from 0 to 100. |
| Other | Change From Baseline OA Function in the Target Knee | Baseline and Week 52 | Change from 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) at Week 52. 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 reported ranging from 0 to 100. |
| Other | Change From Baseline in Medial Joint Space Width of Target Knee | Baseline and Week 52 | Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 52. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 | Baseline and Week 13 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline OA Pain in the Target Knee | Baseline and Week 26 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline OA Function in the Target Knee | Baseline and Week 13 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline OA Function in the Target Knee | Baseline and Week 26 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline OA Disease Activity as Assessed by the Patient | Baseline and Week 13 | mm | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline OA Disease Activity as Assessed by the Patient | Baseline and Week 26 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in Medial Joint Space Width of Target Knee | Baseline and Week 26 | mm | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Change From Baseline OA Pain in the Target Knee | Baseline and Week 52 | score on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Change From Baseline OA Function in the Target Knee | Baseline and Week 52 | score on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Change From Baseline in Medial Joint Space Width of Target Knee | Baseline and Week 52 | mm | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group52
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 | 0.03 mg SM04690 | -23.3 | Standard Error 2.2 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee | 0.07 mg SM04690 | -23.5 | Standard Error 2.1 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee | 0.23 mg SM04690 | -21.3 | Standard Error 2.2 | score on a scale | |
| Change From Baseline Osteoarthritis (OA) Pain in the Target Knee | Placebo | -22.1 | Standard Error 2.1 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee | 0.03 mg SM04690 | -24.7 | Standard Error 2.3 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee | 0.07 mg SM04690 | -27.3 | Standard Error 2.0 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee | 0.23 mg SM04690 | -23.3 | Standard Error 2.1 | score on a scale | |
| Change From Baseline OA Pain in the Target Knee | Placebo | -24.4 | Standard Error 2.1 | score on a scale | |
| Change From Baseline OA Function in the Target Knee | 0.03 mg SM04690 | -24.5 | Standard Error 2.1 | score on a scale | |
| Change From Baseline OA Function in the Target Knee | 0.07 mg SM04690 | -26.3 | Standard Error 2.0 | score on a scale |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.03 mg SM04690 | 112 | |
| Overall Study | STARTED | 0.07 mg SM04690 | 117 | |
| Overall Study | STARTED | 0.23 mg SM04690 | 110 | |
| Overall Study | STARTED | Placebo | 116 | |
| Overall Study | COMPLETED | 0.03 mg SM04690 | 103 | |
| Overall Study | COMPLETED | 0.07 mg SM04690 | 107 | |
| Overall Study | COMPLETED | 0.23 mg SM04690 | 95 | |
| Overall Study | COMPLETED | Placebo | 97 | |
| Overall Study | NOT COMPLETED | 0.03 mg SM04690 | 9 | |
| Overall Study | NOT COMPLETED | 0.07 mg SM04690 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events240
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 | Anaemia | Blood and lymphatic system disorders | 0.03 mg SM04690 | 0 | 111 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.07 mg SM04690 | 1 | 114 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 0.23 mg SM04690 | 1 | 104 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 108 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Other | 1 | 15 | 1 |
| other | Vertigo | Ear and labyrinth disorders | 0.03 mg SM04690 | 0 | 111 | 0 |
| other | Vertigo | Ear and labyrinth disorders | 0.07 mg SM04690 | 0 | 114 | 0 |
| other | Vertigo | Ear and labyrinth disorders | 0.23 mg SM04690 | 0 | 104 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 108 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Other | 1 | 15 | 1 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.03 mg SM04690 | 0 | 111 |
| Total, all-cause mortality | 0.07 mg SM04690 | 0 | 114 |
| Total, all-cause mortality | 0.23 mg SM04690 | 0 | 104 |
| Total, all-cause mortality | Placebo | 0 | 108 |
| Total, all-cause mortality | Other | 0 | 15 |
| Total, other adverse events | 0.03 mg SM04690 | 25 | 111 |
| Total, other adverse events | 0.07 mg SM04690 | 23 | 114 |
| Total, other adverse events | 0.23 mg SM04690 | 19 | 104 |
| Total, other adverse events | Placebo | 18 | 108 |
| Total, other adverse events | Other | 11 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT02536833
GET https://conductscience.org/api/trials/v1/NCT02536833/results?page=2