A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone marrow lesions.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.

Criteria

Key Inclusion Criteria:

• Male at least 50 years of age, or postmenopausal female

• Meets the ACR clinical criteria for knee osteoarthritis

• Bone Marrow Lesion of the knee present on MRI

• Additional criteria may apply

Key Exclusion Criteria:

• Previous surgery on index knee

• Any prior use of bisphosphonates within 6 months of screening

• Additional criteria may apply