Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Phase 2 Completed 518 enrolled Levicept Nordic Bioscience Clinical Development (NBCD) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 2, randomized, double-blind, placebo-controlled trial of multiple doses and multiple administrations of LEVI-04 for the treatment of pain due to osteoarthritis of the knee.

Timeline

Start: 2022-10-19
Primary completion: 2024-05-20
Completion: 2024-05-20

Publications

Conaghan PG, Katz N, Bihlet AR, Guermazi A, Rom D, Perkins MC, Hughes B, Herholdt C, Bombelka I, Westbrook S. Efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2026 Mar 28;407(10535):1237-1248. doi: 10.1016/S0140-6736(26)00131-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	LEVI-04	Protein / enzyme biologic	0.3 mg/kg	Intravenous
Comparator	LEVI-04	Protein / enzyme biologic	1 mg/kg	Intravenous
Comparator	LEVI-04	Protein / enzyme biologic	2 mg/kg	Intravenous

Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Summary

Timeline

Publications

Drugs

Indications