Adults 40 to 80, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in OA Pain in the Target Knee (Pain NRS)Primary· Baseline and Week 12
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain numeric rating scale (NRS). 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.
Group
Value
95% CI
0.07 mg Lorecivivint
-2.24
± 0.13
Vehicle
-2.49
± 0.13
Change From Baseline in OA Pain in the Target Knee (Pain NRS)Secondary· Baseline and Week 24
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). 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.
Group
Value
95% CI
0.07 mg Lorecivivint
-2.42
± 0.14
Vehicle
-2.56
± 0.13
Change From Baseline in OA Pain in the Target Knee (Pain NRS)Secondary· Baseline and Week 52
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). 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.
Group
Value
95% CI
0.07 mg Lorecivivint
-2.31
± 0.14
Vehicle
-2.47
± 0.14
Change From Baseline in OA Function in the Target Knee (WOMAC Function)Secondary· Baseline and Week 12
Evaluate change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used 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 an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest
Group
Value
95% CI
0.07 mg Lorecivivint
-21.87
± 1.34
Vehicle
-23.67
± 1.34
Change From Baseline in OA Function in the Target Knee (WOMAC Function)Secondary· Baseline and Week 24
Evaluate change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used 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 an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest
Group
Value
95% CI
0.07 mg Lorecivivint
-23.07
± 1.42
Vehicle
-23.93
± 1.41
Change From Baseline in OA Function in the Target Knee (WOMAC Function)Secondary· Baseline and Week 52
Evaluate change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used 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 an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest
Group
Value
95% CI
0.07 mg Lorecivivint
-22.08
± 1.48
Vehicle
-22.95
± 1.48
Change From Baseline in OA Disease Activity (Patient Global Assessment)Secondary· Baseline and Week 12
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right).
For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Group
Value
95% CI
0.07 mg Lorecivivint
-25.26
± 1.45
Vehicle
-25.89
± 1.45
Change From Baseline in OA Disease Activity (Patient Global Assessment)Secondary· Baseline and Week 24
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right).
For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Group
Value
95% CI
0.07 mg Lorecivivint
-25.41
± 1.50
Vehicle
-26.31
± 1.50
Change From Baseline in OA Disease Activity (Patient Global Assessment)Secondary· Baseline and Week 52
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right).
For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Group
Value
95% CI
0.07 mg Lorecivivint
-23.79
± 1.63
Vehicle
-24.76
± 1.63
Change From Baseline in Medial Joint Space Width (mJSW) in the Target KneeSecondary· Baseline and Week 52
Evaluate change from baseline in mJSW as documented by radiograph of the target knee
Group
Value
95% CI
0.07 mg Lorecivivint
-0.10
± 0.03
Vehicle
-0.07
± 0.03
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
0.07 mg Lorecivivint
Serious: 12/249 (5%)
Deaths: 1/249
Vehicle
Serious: 13/252 (5%)
Deaths: 0/252
Serious adverse events (28 terms)
Reaction
System
0.07 mg Lorecivivint
Vehicle
COVID-19 pneumonia
Infections and infestations
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Rib fracture
Injury, poisoning and procedural complications
—
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
—
Alcoholic pancreatitis
Gastrointestinal disorders
—
—
Clostridium difficile infection
Infections and infestations
—
—
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05603754 — A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatm
· Phase 3
· completed
NCT04931667 — 3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis
· Phase 3
· terminated
NCT04520607 — A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
· Phase 3
· terminated
NCT04385303 — Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
· Phase 3
· completed
Other recruiting trials for Knee Osteoarthritis
Currently open trials in the same condition.
NCT06906939 — A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression
· EARLY_PHASE1
· recruiting
NCT05823727 — Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing Afte
· NA
· recruiting
NCT07370480 — Knee Osteoarthritis and Thermal Spa Treatment
· NA
· recruiting
NCT07507175 — Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis
· NA
· recruiting
NCT07386600 — Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA
· NA
· recruiting
Other Biosplice Therapeutics, Inc. trials
Trials by the same sponsor.
NCT05603754 — A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatm
· Phase 3
· completed
NCT05084859 — A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With H
· Phase 1
· terminated
NCT04931667 — 3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis
· Phase 3
· terminated
NCT04598542 — Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers
· Phase 1
· completed
NCT04520607 — A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biosplice Therapeutics, Inc.
Last refreshed: 13 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03928184.