A Controlled Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Intra-Articular Injection of a Solution of High and Low Molecular Weight Sodium Hyaluronate (HL-01) in the Treatment of Pain in Symptomatic Knee Osteoarthritis

The goal of this clinical trial is to test HL-01 in patients with knee osteoarthritis pain. The main question[s] it aims to answer are:

• Measure the change in average daily knee pain intensity scores from baseline to the end of the study using a pain scale that measures pain on a scale of 0 to 10
• Measure the change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scales measuring knee pain, stiffness, and function from baseline to the end of the study
• Measure the change in EuroQol EQ-5D-5L quality of life assessments from baseline to end of the study
• Measure change of participant and physician assessment of how the target knee pain and function are affected by the condition from baseline to end of the study
• Measure how often rescue medication is taken from baseline to end of the study
• Assess how well participants tolerate the study medication injection (investigational drug or placebo)
• Assess whether there are any adverse reactions or side effects from the study medication injection

Participants will be asked to complete the following:

• Provide informed consent
• Knee X-ray of target knee
• Complete physical health assessments (e.g., target knee assessment, height, weight, physical exam) at several timepoints throughout the study
• Provide demographic information and their medical/surgical history
• Provide blood and urine samples at several timepoints throughout the study
• Injection of study medication (investigational drug or placebo)

• Complete electronic diaries for the following:

  • Record average daily knee pain intensity scores during screening to confirm eligibility for the study
  • Record average daily knee pain intensity scores after receiving the study medication injection until they complete the study
  • Complete WOMAC scales assessing knee pain, stiffness, and function at baseline, Week 6, Week 12 and/or the end of the study
  • Complete EuroQol EQ-5D-5L quality of life assessments at baseline, Week 6, Week 12 and/or the end of the study
  • Complete global assessment of how the target knee pain and function are affected by the condition at baseline, Week 6, Week 12 and/or the end of the study

Study Overview

• Status: Not yet recruiting
• Conditions: Osteo Arthritis of the Knee
• Intervention / Treatment: Drug: Sodium hyaluronate solution - 3.36%; Drug: Sterile buffered solution

• Study Type: Interventional
• Enrollment (Estimated): 704
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marta Bignamini; Phone Number: +4 158 360 1666; Email: marta.bignamini@ibsa.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age is between 40 and 80 years of age
• Have symptoms of knee osteoarthritis (OA) for at least 6 months
• Meet American College of Rheumatology criteria (clinical and radiological) for knee OA
• Body mass index (BMI) is less than or equal to 40 kg/m2
• Target knee x-ray grade Kellgren-Lawerence (KL) grade 2 or 3
• Have failed at least one prior conservative therapy for knee OA in last 12 months, which includes physical therapy, NSAIDs, and other pain medications
• The knee pain scores during screening and baseline must meet specified qualifying criteria for both the target and the contralateral (non-target) knees
• Willing to complete all electronic diaries and only use study-provided acetaminophen for pain management while participating in the study
• Have negative pregnancy tests during Screening and prior to injection and will not be pregnant or nursing or plan to be pregnant while participating in the study
• Must use a highly effective birth control method if sexually active

Exclusion Criteria:

• Have taken or had any prohibited medications, supplements, or therapies that could have an influence on study assessments. Some may be permitted with stable dose or after stopping for a period of time. Please refer to physician for further details.
• Have active infections or target knee conditions that may compromise study drug administration
• Have exclusionary lab values determined during Screening
• Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee
• Have or had primarily patellofemoral OA, severe malalignment, certain knee surgeries, or other excluded target knee conditions
• Have joint disorders, uncontrolled fibromyalgia, or clinically significant conditions that could interfere with study assessments or compromise participant safety
• Received another clinical trial therapy, medication, or product with 90 days of Screening
• Have non-compliance with study diaries during Screening
• Involved in litigation, disability, or worker's compensation matters based on OA pain
• Allergic to study drug, HA, placebo, or acetaminophen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High and Low Molecular Weight Sodium Hyaluronate (HL-01); Patients will receive single intra-articular knee injection of 3.36% HL-01.	Drug: Sodium hyaluronate solution - 3.36%; Sodium hyaluronate solution, 3.36%, for intra-articular injection.
Placebo Comparator: Sterile buffered solution; Patients randomized to placebo will receive single intra-articular knee injection of 3.36% sterile buffered solution (sodium chloride).	Drug: Sterile buffered solution; Sodium chloride, for intra-articular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of the average daily pain intensity score.	The average daily (24 hour) pain intensity score will be measured on a numeric rating scale (NRS) ranging from 0 to 10. The Baseline value will be the mean of the daily records over the 7-day period before Day 1.	From Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Change in WOMAC function subscale from Baseline to Week 12.	Baseline to Week 12.

Collaborators and Investigators

• Sponsor: IBSA Institut Biochimique SA

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 9, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis of the knee
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 24US-Hai08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No