Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

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

Inclusion Criteria:

1. Aged 50 to 75 years old (inclusive), gender unrestricted;
2. Body Mass Index (BMI) within the range of 18 ≤ BMI ≤ 35;
3. 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;
4. 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;
5. 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;
6. 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;
7. 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;
8. Willing to cooperate with the clinical trial and able to sign the informed consent form.

Exclusion Criteria:

1. With other diseases that cause knee pain and dysfunction (e.g., autoimmune arthritis, infectious arthritis, gouty arthritis, knee joint tumors, etc.);
2. With pain in other body parts exceeding knee pain, which may interfere with the assessment of the knee joint;
3. With significantly narrowed joint space or bony ankylosis due to bone bridge formation between joints;
4. With lower extremity pain caused by lumbar spinal stenosis or lumbar disc herniation;
5. With systemic infection or severe local infection;
6. With clinically significant abnormalities in any item of the four infectious disease screening tests;
7. With a history of knee joint surgery, open trauma within 1 year, or intra-articular injection, radiotherapy, or arthroscopy within 6 months;
8. With intra-articular corticosteroid block therapy for the knee joint or long-term (continuous ≥2 weeks) use of corticosteroids or immunosuppressants within 6 months;
9. With a history of taking Chinese herbal decoctions or proprietary Chinese medicines for knee pain within 1 month;
10. With physical therapy or topical medication (e.g., electromagnetic therapy, cupping, acupuncture, plasters, fumigation, etc.) on the knee joint within 1 week;
11. With severe diseases of the heart, brain, liver, kidney, hematologic, endocrine, or immune systems (e.g., AST/ALT or creatinine ≥2.0×ULN, glycosylated hemoglobin ≥8%, hemophilia, etc.);
12. With malignant tumors;
13. Planning to undergo elective knee joint surgery during the study period;
14. With obvious knee joint effusion (significant joint swelling or bulging) or severe venous/lymphatic stasis of the lower extremities;
15. Requiring long-term use of warfarin or other anticoagulants (except for a stable daily dose of aspirin ≤100 mg and/or clopidogrel);
16. With consciousness disturbance or mental illness, unable to complete self-assessment;
17. With a history of drug abuse or alcoholism;
18. With a history of allergy to the raw materials of the study product and control product, or atopic diathesis (previous allergy to protein-based drugs or food);
19. With a positive pregnancy test, pregnant/lactating women, those with recent childbearing plans, or those unable to take reliable contraceptive measures during the study;
20. Having participated in other clinical trials of drugs, biological agents, or medical products within 3 months;
21. Other circumstances deemed inappropriate for participation in this clinical trial by the investigator.

Conditions2

Interventions1

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