Phase II Clinical Trial of LEVI-04

Phase II Clinical Trial of LEVI-04

Levicept is conducting a multiple arm, multicenter, prospective, randomized, double-blind, placebo-controlled, Phase II study of LEVI-04 intravenous infusion for the treatment of pain due to osteoarthritis of the knee. The purpose of the trial is to evaluate the efficacy, safety, and tolerability of five monthly infusions of LEVI-04 as compared to placebo in participants with radiographic and symptomatic knee osteoarthritis. Up to 624 participants will be enrolled and randomized to one of four Treatment Arms at the ratio 1:1:1:1. ClinicalTrials.gov ID: NCT05618782

Nordic Bioscience is the lead CRO for the trial.

Levicept successfully completed a Phase I clinical trial with LEVI-04 in March 2021. The trial confirmed favourable safety, tolerability and pharmacokinetic profile. Analysis of biomarkers indicated target engagement and provided early supporting evidence of efficacy / proof-of-concept, ClinicalTrials.gov ID: NCT03227796

For general information regarding LEVI-04 please contact info@levicept.com