Single-Center, Randomized, Double-Blind, Parallel-Controlled Clinical Trial to Evaluate the Efficacy and Safety of ALT001 for Osteoarthritis
This clinical trial will focus on the core efficacy endpoints including relief of pain intensity, improvement of joint motor function and enhancement of quality of life in patients. Meanwhile, it will strictly monitor key safety indicators such as the occurrence of various adverse events after medication, the severity and duration of adverse reactions, and conduct a multi-dimensional and multi-level comprehensive assessment. The study aims to clarify the clinical benefit profile and safety risks of the investigational product ALT001, and provide scientific, detailed and reliable evidence-based medical data to support the optimization of clinical treatment guidelines and the formulation of individualized treatment regimens for knee osteoarthritis. Patients enrolled in the trial will receive investigational product treatment on the basis of conventional therapy. They will be randomly assigned to the placebo group, low-dose group and high-dose group at a ratio of 1:1:1. For each treatment course, patients in all groups will receive an injection of 2 vials of the investigational product into a single knee joint (for bilateral knee osteoarthritis, both knees may be injected, with one fixed knee joint selected for subsequent assessments). The injection will be administered once every 2 weeks for a total of 6 administrations.
• Aged 50 to 75 years old (inclusive), gender unrestricted;
• Body Mass Index (BMI) within the range of 18 ≤ BMI ≤ 35;
• Meets the diagnostic criteria for osteoarthritis (OA) in Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2021 Edition) \[1\]. A diagnosis of knee osteoarthritis can be made if criterion ① plus any 2 of criteria ②, ③, ④, ⑤ are satisfied:
• ① Recurrent knee pain within the past 1 month;
• ② X-ray (standing or weight-bearing position) shows narrowed joint space, subchondral bone sclerosis and/or cystic changes, and osteophyte formation at the joint margin;
• ③ Aged ≥ 50 years;
• ④ Morning stiffness duration ≤ 30 minutes;
• ⑤ Crepitus (sensation or sound) during joint movement;
• Kellgren-Lawrence grade of Grade Ⅰ to Ⅲ for at least one knee joint on anteroposterior and lateral (stress) X-ray of bilateral knee joints within 6 months;
• A score of 4 to 8 points (inclusive) for pain on flat ground walking or stair climbing in the WOMAC Pain Score of at least one knee joint;
• For participants who have been taking glucosamine or diacerein-containing drugs before the screening period, the dosage must be kept stable throughout the entire clinical trial;
• Discontinued all analgesic drugs for more than 2 weeks before the screening period, and agreed not to use any other analgesic drugs except rescue medication throughout the entire study;
• Willing to cooperate with the clinical trial and able to sign the informed consent form.