Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

NCT07404891 | Recruiting DMC

• 1 other identifier: ALT001-CN-IIT-09002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Change in the WOMAC Pain Score of the target knee joint at 24 weeks (14 weeks after the last injection) compared with the baseline.

  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.

  24 weeks (14 weeks after the last injection)

• 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.

  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.)

  14 weeks

Secondary Outcomes (4)

• Changes in the WOMAC Physical Function Score of the target knee joint at 2, 4, 6, 8, 10, 12, 18 (non-mandatory) and 24 weeks compared with the baseline.

  2, 4, 6, 8, 10, 12, 18(non-mandatory)

• Changes in the WOMAC Total Score of the target knee joint at 2, 4, 6, 8, 10, 12, 18 (non-mandatory) and 24 weeks compared with the baseline.

  2, 4, 6, 8, 10, 12, 18 (non-mandatory) and 24 weeks

• Changes in the VAS Pain Score of the target knee joint at 2, 4, 6, 8, 10, 12, 18 (non-mandatory) and 24 weeks compared with the baseline.

  2, 4, 6, 8, 10, 12, 18 (non-mandatory) and 24 weeks

• Deep proteomics indicators

  During treatment and at 14 weeks post-treatment

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

2 vials per administration, once every 2 weeks, intra-articular injection.

Other: Placebo

ALT001 Low-Dose Group

EXPERIMENTAL

1 vial per administration, once every 2 weeks, intra-articular injection.

Drug: ALT001

ALT001 High-Dose Group

EXPERIMENTAL

2 vials per administration, once every 2 weeks, intra-articular injection.

Drug: ALT001

Interventions

Placebo OTHER

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

Placebo Group

ALT001 DRUG

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

ALT001 High-Dose Group; ALT001 Low-Dose Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• With other diseases that cause knee pain and dysfunction (e.g., autoimmune arthritis, infectious arthritis, gouty arthritis, knee joint tumors, etc.);
• With pain in other body parts exceeding knee pain, which may interfere with the assessment of the knee joint;
• With significantly narrowed joint space or bony ankylosis due to bone bridge formation between joints;
• With lower extremity pain caused by lumbar spinal stenosis or lumbar disc herniation;
• With systemic infection or severe local infection;
• With clinically significant abnormalities in any item of the four infectious disease screening tests;
• With a history of knee joint surgery, open trauma within 1 year, or intra-articular injection, radiotherapy, or arthroscopy within 6 months;
• With intra-articular corticosteroid block therapy for the knee joint or long-term (continuous ≥2 weeks) use of corticosteroids or immunosuppressants within 6 months;
• With a history of taking Chinese herbal decoctions or proprietary Chinese medicines for knee pain within 1 month;
• With physical therapy or topical medication (e.g., electromagnetic therapy, cupping, acupuncture, plasters, fumigation, etc.) on the knee joint within 1 week;
• 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.);
• With malignant tumors;
• Planning to undergo elective knee joint surgery during the study period;
• With obvious knee joint effusion (significant joint swelling or bulging) or severe venous/lymphatic stasis of the lower extremities;
• Requiring long-term use of warfarin or other anticoagulants (except for a stable daily dose of aspirin ≤100 mg and/or clopidogrel);

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Xiaodong Guo, PhD

CONTACT

027-85871865; xiaodongguo@hust.edu.cn

Zekang Xiong, PhD

CONTACT

027-85871865; xzkrunus@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 12, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the project finished，publications on this study will be available from PubMed.
• Access Criteria: Relevant data may be requested via xiaodongguo@hust.edu.cn.

Locations

CN (1)