Efficacy and Safety of XT-150 in Osteoarthritis of the Knee

Phase 2 Completed 289 enrolled Xalud Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee.

Timeline

Start: 2020-02-14
Primary completion: 2022-04-26
Completion: 2022-04-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Stage A: 0.15 mg/ml XT-150 vs Stage A: Placebo; Odds Ratio (OR) 0.655 (95% CI 0.347 to 1.237) NCT04124042 ↗

registry analysis (superiority test); Stage A: 0.15 mg/ml XT-150 vs Stage A: Placebo; p = 0.413; Mean Difference (Final Values) 0.44 (95% CI -0.62 to 1.50); Mixed Models Analysis NCT04124042 ↗

registry analysis (superiority test); Stage A: 0.45 mg/ml XT-150 vs Stage A: Placebo; p = 0.629; Mean Difference (Final Values) 0.26 (95% CI -0.79 to 1.31); Mixed Models Analysis NCT04124042 ↗

Publications

Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	XT-150	Other / unclassified	0.15 mg/ml	Other
Subject	XT-150	Other / unclassified	0.45 mg/ml	Other