Phase III Clinical Trial of LEVI-04
Levicept is developing a Phase III clinical plan for LEVI-04, a first-in-class treatment for osteoarthritis and other pain indications. The treatment will be developed for subcutaneous self-administration.
We don’t currently have any clinical studies that are open to new patients, but this may be possible at the next stage of clinical development.
Phase II Clinical Trial of LEVI-04
Levicept successfully completed a pivotal multiple arm, multicentre, prospective, randomized, double-blind, placebo-controlled, Phase II study of LEVI-04 monthly intravenous infusion for the treatment of pain due to osteoarthritis (OA) of the knee in July 2024.
The trial recruited more than 510 patients and was designed 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.
LEVI-04 demonstrated significant differences to placebo at Week 17 for all primary and secondary endpoints for all doses evaluated:
- The primary endpoint was WOMAC[1] pain assessment (change from baseline at Week 17). The mean reduction in WOMAC pain score from baseline was greater than 50% for all three doses of LEVI-04 and all statistically different to placebo.
- Secondary endpoints were WOMAC subscales of function and joint stiffness, patient global assessment and daily pain scores and all statistically different to placebo.
Standard safety monitoring plus peripheral nervous system assessments showed LEVI-04 to be well tolerated. There was no increase in incidence of rapidly progressive osteoarthritis (RPOA) as measured via detailed, closely examined, radiographic analysis.
ClinicalTrials.gov ID: NCT05618782.
[1] The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale – a recognised standard pain scale
Phase I Clinical Trial of LEVI-04
Levicept successfully completed a Phase I clinical trial with LEVI-04 in healthy volunteers and patients with osteoarthritis in March 2021. The trial confirmed the favourable safety, tolerability and pharmacokinetic profile of LEVI-04.
ClinicalTrials.gov ID: NCT03227796