Evaluating the Efficacy and Safety of Intra-articular Injection of HS-20116 in Patients With Knee Osteoarthritis

NCT07047196 | Completed Phase 3

• 1 other identifier: HS-20116-301
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the efficacy and safety of HS-20116 for intra-articular use in patients with symptomatic knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis,Hansoh, Chitosan Solution for Intra-Articular Use

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score

  Change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at Week 12 after the first injection.

  12 weeks after the first injection.

Study Arms (2)

HS-20116

EXPERIMENTAL

HS-20116 administered as a single intra-articular injection (3 mL per dose)

Device: HS-20116

Medical Chitosan (for intra-articular injection)

ACTIVE COMPARATOR

Medical Chitosan administered as 2-3 intra-articular injections (2-3 mL per dose) in total.

Device: Medical Chitosan (for intra-articular injection)

Interventions

HS-20116 DEVICE

Innovative chitosan-based biomaterial intended for intra-articular injection

HS-20116

Medical Chitosan (for intra-articular injection) DEVICE

Medical chitosan for intra-articular injection

Medical Chitosan (for intra-articular injection)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 40-85 years (inclusive);
• Body mass index (BMI) ≤ 35 kg/m2;
• Primary knee osteoarthritis in accordance with the clinical and radiological diagnostic criteria of the American College of Rheumatology (ACR), unilateral or bilateral femorotibial arthritis, with or without patellofemoral arthritis;
• A radiographic Kellgren and Lawrence (K\&L) grade of II to III in the treated knee within 6 months prior to randomization;
• Recurrent knee pain for at least 6 months at screening, with no or poor response to the first-line oral non-opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDS);
• After a washout period of 48 h for analgesics, the degree of pain before bilateral knee injection was assessed using the WOMAC pain score (5-grade Likert method) prior to randomization, which should meet the following criteria:
• Treated knee: WOMAC pain score of 7-17, of which item A1 was at least 2;
• Non-treated knee: WOMAC pain score of no more than 6.
• Completely free to move;
• Willing to undergo a 48-h analgesic washout period prior to visit;

You may not qualify if:

• Concomitant synovial chondromatosis and villonodular synovitis of the knee;
• Patellofemoral osteoarthritis only, where symptoms including pain mostly originated from the patellofemoral joint (patellofemoral pain syndrome);
• Onset of clinically significant knee effusion, knee inflammation or associated symptoms, or abnormal gross examination or volume of synovial fluid at the time of joint aspiration on the day of injection;
• Obvious varus or valgus deformity of the treated knee after clinical evaluation or imaging evaluation as judged by the investigator;
• Concomitant autoimmune diseases, autoinflammatory diseases, or infectious arthritis, such as rheumatoid arthritis, psoriatic arthritis, articular chondrocalcinosis, gout, ankylosing spondylitis, and lupus erythematosus;
• Other concomitant pathological changes affecting joint treatment/evaluation, such as arthrodysplasia, ipsilateral hip osteoarthritis, aseptic bone necrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, lumbosacral radicular pain, femoral nerve or sciatic nerve radicular pain, venous or lymphatic obstruction, arteritis, tendon disorder, etc.;
• Skin infection, skin lesions, or chronic dermatosis at the puncture site;
• Any knee injury, surgical history, or arthroscopy and treatment within 6 months prior to screening; or any surgery or other invasive operation expected to be performed during the trial;
• Prior injection with hyaluronic acid into the treated knee within 6 months prior to randomization.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Affiliated hospital of nantong university

Nantong, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Liu Fan

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: August 13, 2024
• Primary Completion: February 26, 2025
• Study Completion: April 27, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)