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Showing 1–13 of 13 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: SM04690 Clear all
Completed Phase 2 Interventional Results available

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

NCT03727022
View directory record Official record
Conditions
Knee Osteoarthritis
Interventions
Placebo, SM04690
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
13
States / cities
Phoenix, Arizona • Canoga Park, California • Carmichael, California + 9 more
Source: ClinicalTrials.gov public record
Updated Jan 11, 2026 · Synced Sep 3, 2026, 2:31 AM EDT
Terminated Phase 1 Interventional

A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease

NCT03246399
View directory record Official record
Conditions
Degenerative Disc Disease
Interventions
SM04690
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
25 Years to 55 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
4
States / cities
San Diego, California • Charleston, South Carolina • Tyler, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 22, 2019 · Synced Sep 3, 2026, 2:31 AM EDT
Completed Phase 1 Interventional

Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

NCT02095548
View directory record Official record
Conditions
Moderate to Severe Osteoarthritis
Interventions
SM04690, 0.03mg/2mL, SM04690, 0.07mg/2mL, SM04690, 0.23mg/2mL, Placebo
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
50 Years to 75 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
7
States / cities
Tucson, Arizona • El Cajon, California • Walnut Creek, California + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 9, 2015 · Synced Sep 3, 2026, 2:31 AM EDT
Completed Phase 3 Interventional Results available

Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis

NCT03928184
View directory record Official record
Conditions
Knee Osteoarthritis
Interventions
Lorecivivint, Placebo
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
501 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
99
States / cities
Birmingham, Alabama • Peoria, Arizona • Phoenix, Arizona + 85 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2026 · Synced Sep 3, 2026, 2:31 AM EDT
Completed Phase 3 Interventional Results available

Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)

NCT04385303
View directory record Official record
Conditions
Knee Osteoarthritis
Interventions
Lorecivivint, Placebo
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
496 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
76
States / cities
Birmingham, Alabama • Mobile, Alabama • Phoenix, Arizona + 69 more
Source: ClinicalTrials.gov public record
Updated Feb 3, 2026 · Synced Sep 3, 2026, 2:31 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers

NCT04598542
View directory record Official record
Conditions
Drug-Drug Interaction
Interventions
Lorecivivint (LOR), Triamcinolone acetonide (TA)
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jan 11, 2021 · Synced Sep 3, 2026, 2:31 AM EDT
Terminated Phase 2 Interventional Results available

MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis

NCT03706521
View directory record Official record
Conditions
Knee Osteoarthritis
Interventions
lorecivivint
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Mar 3, 2026 · Synced Sep 3, 2026, 2:31 AM EDT
Completed No phase listed Observational

An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis

NCT02951026
View directory record Official record
Conditions
Osteoarthritis
Interventions
Not applicable (no therapy is administered as part of this study)
Other
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
703 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
62
States / cities
Birmingham, Alabama • Oro Valley, Arizona • Phoenix, Arizona + 59 more
Source: ClinicalTrials.gov public record
Updated Apr 16, 2020 · Synced Sep 3, 2026, 2:31 AM EDT
Completed Phase 2 Interventional Results available

A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

NCT02536833
View directory record Official record
Conditions
Osteoarthritis
Interventions
SM04690, Placebo
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
455 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
36
States / cities
Mobile, Alabama • Phoenix, Arizona • Tucson, Arizona + 32 more
Source: ClinicalTrials.gov public record
Updated Mar 16, 2021 · Synced Sep 3, 2026, 2:31 AM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES)

NCT05603754
View directory record Official record
Conditions
Knee Osteoarthritis
Interventions
Lorecivivint, Placebo
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
499 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
44
States / cities
Tucson, Arizona • Cerritos, California • La Mesa, California + 35 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 3, 2026, 2:31 AM EDT
Completed Phase 2 Interventional Results available

A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

NCT03122860
View directory record Official record
Conditions
Knee Osteoarthritis
Interventions
SM04690, Placebo, Sham
Drug · Other
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
700 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
74
States / cities
Anniston, Alabama • Birmingham, Alabama • Mobile, Alabama + 68 more
Source: ClinicalTrials.gov public record
Updated Jun 10, 2021 · Synced Sep 3, 2026, 2:31 AM EDT
Terminated Phase 3 Interventional Results available

3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis

NCT04931667
View directory record Official record
Conditions
Osteoarthritis of the Knee
Interventions
Lorecivivint
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
4
States / cities
Tucson, Arizona • Winter Park, Florida • Oak Brook, Illinois + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 30, 2026 · Synced Sep 3, 2026, 2:31 AM EDT
Terminated Phase 3 Interventional Results available

A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee

NCT04520607
View directory record Official record
Conditions
Osteoarthritis, Knee
Interventions
Placebo, Lorecivivint
Drug
Lead sponsor
Biosplice Therapeutics, Inc.
Industry
Eligibility
41 Years to 81 Years
Enrollment
276 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
42
States / cities
Tucson, Arizona • Anaheim, California • Pomona, California + 39 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2026 · Synced Sep 3, 2026, 2:31 AM EDT