NCT03122860

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

A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	SM04690	Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
OTHER	Placebo	Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
OTHER	Sham	Healthcare professional-administered intra-articular injection performed once on Day 1 of the study

Timeline

• Start date: 2017-04-24
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2017-04-21
• Last updated: 2021-06-11
• Results posted: 2021-05-18

Locations

74 sites across 1 country: United States

Regulatory

• FDA-regulated drug study