Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Placebo: Administration Method: Intra-articular injection; the medial and lateral joint spaces are recommended as the injection sites. Total Number of Injections: 6 times

ALT001: Administration Method: Intra-articular injection; the medial and lateral joint spaces are recommended as the injection sites. Total Number of Injections: 6 times

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in the WOMAC Pain Score of the target knee joint at 24 weeks (14 weeks after the last injection) compared with the baseline. — 24 weeks (14 weeks after the last injection)
  The WOMAC Index (Western Ontario and McMaster Universities Osteoarthritis Index) is a commonly used assessment tool for evaluating symptom severity and joint function in patients with knee joint disorders \[6\]. It comprises three dimensions: pain, stiffness, and physical function. Through the assessment of these three dimensions, the degree of pain, joint mobility, and difficulty in performing daily activities in patients' daily lives can be objectively evaluated. The WOMAC score is a composite rating of the patient's subjective experience within the 48 hours prior to each assessment. WOMAC Pain Score includes five items: pain when walking on a flat surface, climbing up or down stairs, pain at night, pain when sitting or lying down, and pain when standing upright. For detailed scoring criteria, see Annex 1. During the treatment period and the final follow-up period, the pain assessment is based on the patient's experience within the 48 hours prior to the current visit.
• Changes in the levels of inflammatory factors IL-1β, IL-6, and TNF-α in the synovial fluid of the target knee joint during treatment and at 14 weeks post-treatment compared with the baseline. — 14 weeks
  IL-1β, IL-6, and TNF-α, the three cytokines, can promote the production of other inflammatory factors by activating the NF-κB and MAPK signaling pathways, thereby exacerbating the degree of inflammatory response. Although this interaction can trigger a more robust immune response, it may also induce chronic inflammation and tissue damage. The levels of IL-1β, IL-6, and TNF-α serve as important predictive markers for monitoring the disease progression of osteoarthritis (OA). (For patients from whom synovial fluid cannot be aspirated, irrigate the joint cavity with 5 ml of sterile water for injection first before aspiration; the entire procedure must be performed under strict aseptic conditions.)

Trial sites (1)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

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