NCT05618782

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

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Levicept · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of a Screening Period (including a Diary Run- In/analgesic wash-out Period), Randomization, Post-Randomization Period, and a Follow-up Period. Up to 624 participants will be enrolled and randomized to one of four Treatment Arms at the ratio 1:1:1:1 The overall objective of this study is to evaluate the efficacy and safety of LEVI-04 compared to placebo in patients with knee OA.

Conditions

• Pain
• Osteo Arthritis Knee
• Knee Osteoarthritis
• Arthritis
• Joint Diseases
• Musculoskeletal Diseases
• Rheumatic Diseases

Interventions

Type	Name	Description
DRUG	LEVI-04	LEVI-04, a fully human chimeric fusion protein that combines the Fc fragment of human immunoglobulin G1 with the p75 neurotrophin receptor (p75 NTR), for the treatment of chronic pain.
OTHER	Placebo	Saline vehicle

Timeline

• Start date: 2022-10-19
• Primary completion: 2024-05-20
• Completion: 2024-05-20
• First posted: 2022-11-16
• Last updated: 2025-11-20
• Results posted: 2025-10-06

Locations

13 sites across 5 countries: Czechia, Denmark, Hong Kong, Moldova, Poland