Loading clinical trials...

MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase 2, 52 Week, Single Center, Open-Label Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 Injectable Suspension for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

NCT03706521•Biosplice Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the safety and efficacy of lorecivivint (LOR) injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects. Efficacy was primarily evaluated via magnetic resonance imaging (MRI).

Detailed Description

This phase 2 study was a single center, open-label study of lorecivivint (LOR) (internal identification SM04690) injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg LOR per 2 mL injection. The primary objective was to evaluate the efficacy of LOR for the treatment of knee OA via magnetic resonance imaging (MRI) by assessing various cartilage health biomarkers, including cartilage thickness, cartilage volume, and cartilage quality and hydration markers. The study was terminated early due to COVID-19-related issues (e.g., temporary site closures impacting data collection).

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

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)
•Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening Visit
•Primary source of pain throughout the body is due to OA in the target knee
•Daily OA knee pain diary average Numeric Rating Scale (NRS) intensity score ≥4 and ≤8 in the target knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1
•Pain NRS scores recorded for the target knee on at least 4 out of the 7 days immediately preceding Day 1
•Daily OA knee pain diary average NRS intensity score \<4 in the non-target knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1
•Pain NRS scores recorded for the non-target knee on at least 4 out of the 7 days immediately preceding Day 1
•Baseline mJSW by radiograph between 2 and 4 mm, inclusive, in the target knee at the Screening Visit as assessed by independent central readers
•Total WOMAC score of 96-192 (out of 240) for the target knee at Day 1 regardless of if the subject is on symptomatic oral treatment
+26 more criteria

Exclusion Criteria

•Women who are pregnant, lactating, or have a positive pregnancy test result at the Screening Visit
•Women of childbearing potential who are sexually active, and who are not willing to use an acceptable method of birth control during the study period
•Men of childbearing potential who are sexually active and have a partner who is capable of becoming pregnant, neither of whom are agreeable to using an acceptable method of birth control during the study period
•Body mass index (BMI) \> 40
•Partial or complete joint replacement in either knee
•Currently requires: a) regular use (in the opinion of the Investigator) of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches), or b) use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware)
•Radiographic disease Stage 0, 1, or 4 in the target knee at the Screening Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by independent central readers
•Previous treatment with lorecivivint (SM04690)
•Subjects who have previously failed screening on this protocol and fail to meet re-screening criteria
•Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to the Screening Visit
+2 more criteria

Locations (1)

Research Site

San Francisco, California, United States

Key Dates

Start Date

March 11, 2019

Primary Completion Date

July 22, 2020

Completion Date

December 21, 2020

Last Updated

March 4, 2026

Enrollment

ACTUAL participants

Conditions

Knee Osteoarthritis

Interventions

lorecivivint

DRUG

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

View study

RECRUITINGNA

General vs Spinal in Total Joint Arthroplasty (TJA)

NCT06747494

Knee OsteoarthritisHip Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

General vs Spinal in Total Joint Arthroplasty (TJA)

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression

ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA

Effectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery.

IDENTIFICATION OF BIOMARKERS ASSOCIATED WITH THE SEVERITY AND RADIO-CLINICAL PROGRESSION OF KNEE OSTEOARTHRITIS