A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Biosplice Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a knee injection called lorecivivint for people with severe knee osteoarthritis. The injection aims to reduce pain and improve movement by targeting the painful knee directly. Lorecivivint (LOR) is being tested for its potential to treat osteoarthritis.

Eligibility Criteria

Inclusion Criteria

Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)

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

Radiographic disease Stage 2 or 3 in target knee within 24 weeks of the Screening Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by independent central readers

Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)

Primary source of pain throughout the body is due to OA in the target knee

Body mass index (BMI) ≤ 35 kg/m2 at the Screening Visit

You have been experiencing knee pain for at least 26 weeks before the screening visit, which is consistent with osteoarthritis.

You are between the ages of 40 and 80 and generally in good health, except for knee osteoarthritis.