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

Recruiting in Palo Alto (17 mi)

+70 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Biosplice Therapeutics, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study also includes one cohort that receives a 2 mL IA injection of vehicle (placebo), and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).

Research Team

Yusuf Yazici, M.D.

Principal Investigator

Biosplice Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

Ambulatory

Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)

Pain compatible with OA of the knee(s) for at least 26 weeks prior to screening

Treatment Details

Interventions

• Placebo (Other)
• Sham (Other)
• SM04690 (Small Molecule)

Participant Groups

Group I: 0.23 mg SM04690 Experimental Treatment 1 Intervention

Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle

Group II: 0.15 mg SM04690 Experimental Treatment 1 Intervention

Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle

Group III: 0.07 mg SM04690 Experimental Treatment 1 Intervention

Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle

Group IV: 0.03 mg SM04690 Experimental Treatment 1 Intervention

Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle

Group V: Sham Placebo Group 1 Intervention

Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle

Group VI: Placebo Placebo Group 1 Intervention

Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle

Who Is Running the Clinical Trial?

Biosplice Therapeutics, Inc.

Lead Sponsor

Trials

22

Recruited

5,300+