Trial · NCT03727022

Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

NCT03727022, Phase 2, Completed, Biosplice Therapeutics, Inc.; results first posted 2026-01-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis. Trials, record NCT03727022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03727022

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
NCT number: NCT03727022
Status: Completed
Phases: Phase 2
Enrollment: 101 participants, actual
Lead sponsor: Biosplice Therapeutics, Inc.
Conditions: Knee Osteoarthritis
Interventions: Placebo, SM04690
First posted: 2018-11-01
Last updated: 2026-01-12
Results first posted: 2026-01-12

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 52	Evaluate change in total bone mineral density (BMD) from baseline in the treated knee compared to placebo by quantitative computed tomography (qCT)
Secondary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Weeks 12	Evaluate change in total BMD from baseline in the treated knee compared to placebo by qCT
Secondary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 24	Evaluate change in total BMD from baseline in the treated knee compared to placebo by qCT
Secondary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 36	Evaluate change in total BMD from baseline in the treated knee compared to placebo by qCT
Secondary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 64	Evaluate change in total bone mineral density (BMD) from baseline in the treated knee compared to placebo by quantitative computed tomography (qCT)
Secondary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 76	Evaluate change in total BMD from baseline in the treated knee compared to placebo by qCT
Secondary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 88	Evaluate change in total BMD from baseline in the treated knee compared to placebo by qCT
Secondary	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 104	Evaluate change in total BMD from baseline in the treated knee compared to placebo by qCT

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 52	Full Analysis Set includes all subjects who received at least one study injection in Phase A. Subjects' observed data were analyzed as randomized for the FAS without imputation.	mg/cm^3	MEAN
SECONDARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Weeks 12	Full Analysis Set includes all subjects who received at least one study injection in Phase A. Subjects' observed data were analyzed as randomized for the FAS without imputation.	mg/cm^3	MEAN
SECONDARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 24	Full Analysis Set includes all subjects who received at least one study injection in Phase A. Subjects' observed data were analyzed as randomized for the FAS without imputation.	mg/cm^3	MEAN
SECONDARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 36	Full Analysis Set includes all subjects who received at least one study injection in Phase A. Subjects' observed data were analyzed as randomized for the FAS without imputation.	mg/cm^3	MEAN
SECONDARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 64	Full Analysis Set (FASB) includes all subjects who received at least one study injection in Phase B. Subjects' observed data were analyzed as randomized for the FASB without imputation.	mg/cm^3	MEAN
SECONDARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 76	Full Analysis Set (FASB) includes all subjects who received at least one study injection in Phase B. Subjects' observed data were analyzed as randomized for the FASB without imputation.	mg/cm^3	MEAN
SECONDARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 88	Full Analysis Set (FASB) includes all subjects who received at least one study injection in Phase B. Subjects' observed data were analyzed as randomized for the FASB without imputation.	mg/cm^3	MEAN
SECONDARY	Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Baseline and Week 104	Full Analysis Set (FASB) includes all subjects who received at least one study injection in Phase B. Subjects' observed data were analyzed as randomized for the FASB without imputation.	mg/cm^3	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Vehicle	-0.47	Standard Deviation 8.21	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	0.07 mg SM04690	-3.32	Standard Deviation 10.00	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Vehicle	-0.38	Standard Deviation 7.89	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	0.07 mg SM04690	-0.34	Standard Deviation 7.28	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Vehicle	1.34	Standard Deviation 7.77	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	0.07 mg SM04690	-0.76	Standard Deviation 8.81	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Vehicle	-1.82	Standard Deviation 8.47	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	0.07 mg SM04690	-2.06	Standard Deviation 7.18	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	Vehicle	-4.56	Standard Deviation 9.84	mg/cm^3
Change in Total BMD From Baseline in the Treated Knee Compared to Placebo by qCT	0.07 mg SM04690	-3.76	Standard Deviation 9.94	mg/cm^3

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase A	STARTED	Vehicle	50
Phase A	STARTED	0.07 mg SM04690	51
Phase A	COMPLETED	Vehicle	38
Phase A	COMPLETED	0.07 mg SM04690	39
Phase A	NOT COMPLETED	Vehicle	12
Phase A	NOT COMPLETED	0.07 mg SM04690	12
Phase B	STARTED	Vehicle	32
Phase B	STARTED	0.07 mg SM04690	33
Phase B	COMPLETED	Vehicle	24
Phase B	COMPLETED	0.07 mg SM04690	29

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events36

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	Blood pressure increased	Investigations	0.07 mg SM04690	4	51	4
other	Blood pressure increased	Investigations	Vehicle	1	50	2
other	Sinusitis	Infections and infestations	0.07 mg SM04690	3	51	4
other	Sinusitis	Infections and infestations	Vehicle	1	50	1
other	COVID-19	Infections and infestations	0.07 mg SM04690	2	51	2
other	COVID-19	Infections and infestations	Vehicle	0	50	0
other	Influenza	Infections and infestations	0.07 mg SM04690	2	51	2
other	Influenza	Infections and infestations	Vehicle	0	50	0
other	Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	0.07 mg SM04690	2	51	2
other	Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Vehicle	0	50	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.07 mg SM04690	0	51
Total, all-cause mortality	Vehicle	0	50
Total, other adverse events	0.07 mg SM04690	11	51
Total, other adverse events	Vehicle	14	50
Total, serious adverse events	0.07 mg SM04690	2	51
Total, serious adverse events	Vehicle	2	50

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
0.07 mg SM04690 vs Vehicle: deaths from any cause	Trial comparisons
0.07 mg SM04690 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03727022

GET https://conductscience.org/api/trials/v1/NCT03727022/events?page=2

API reference For AI assistants