Arthritis Rheumatol: Phase 2 Randomized Trial of Lorevante's Treatment of Knee Osteoarthritis

The study was designed to assess the safety and efficacy of the new Wnt pathway regulator, Lorevent (SM04690), for the treatment of pain and inhibitive structural progression in moderate to severe symptomatic knee osteoarthritis (OA)in the 52-week, 2a, multicenter, randomized, double-blind, placebo (PBO) control, dose range trial, subjects were given a single 2mL joint injection of 0.03 mg, 0.07 mg or 0.23 mg Lorevinte or PBOThe efficacy was evaluated by changes in the subscale of WOMAC pain (0-100) and WOMAC functions ( 0-100) as well as imaging joint gap width (mJSW)Covariance analysis and multiple interpolation were performed after baseline correction to evaluate the efficacyThis proof-of-concept study evaluated the end-of-the-part subgroup (UNIWP-) of the intended treatment population and the pre-determined monolater asymptomatic (UNI) subject group and another one-sided symptomatic subject without extensive pain455 subjects were randomly grouped??。 The main endpoint was compared to the PBO, and the PAIN improved in Week 13None of the dose groups reached the primary endpoint (change from baseline by 0.03 mg, -23.3 to 2.2; 0.07 mg, -23.5 to 2.1; 0.23 mg, -21.3 to 2.2; PBO, -22.1 to 2.1; P.0.05)All groups (including PBO) showed a clinically significant improvement over the baselineWeek 52 assessed the persistence of the responseWeek 52 in the pre-determined UNI and hindi WP groups, 0.07mg Lorivint significantly improved WOMAC pain compared to PBO (group differences:UNI,-8.73--17.44,-0.03) P.049;UNI-,-111.21-20 .99, -1.43, P-0.025) and WOMAC features (UNI, -10.26,-19.82, -0.69) , P-0.036; UNI WP-,-13.38 .24.33, -2.43, P.017)Compared to the baseline, the average change in the 52nd week mJSW was -0.04mm in the 0.03mg queue, -0.09mm in the 0.07mg queue, -0.16mm in the 0.23mg queue and -0.14mm in the PBO groupAt week 52, there was a statistically significant difference between mJSW in none of the treatment group and PBOIn the two one-sided subgroups, the 0.07 mg dose significantly increased mJSW (UNI, 0.39mm ,0.09mm, 0.72), P.021; UNI WP-, 0.42mm .04, 0.80,P.032) significantly increased compared to PBOThere was no statistical difference between the 0.03 mg and 0.23 mg dose groups and The PBOLorevint's safety and tolerance are goodthe 2a,-proof-of-concept trial did not reach the main endpoint; however, it identified a target population that could assess the potential efficacy of Lorevint