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

NCT07819461 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 24US-Hai08
• Study Type: interventional
• Target: 704
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteo Arthritis of the Knee

Keywords

Osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline to Week 12.

Study Arms (2)

High and Low Molecular Weight Sodium Hyaluronate (HL-01)

EXPERIMENTAL

Patients will receive single intra-articular knee injection of 3.36% HL-01.

Drug: Sodium hyaluronate solution - 3.36%

Sterile buffered solution

PLACEBO COMPARATOR

Patients randomized to placebo will receive single intra-articular knee injection of 3.36% sterile buffered solution (sodium chloride).

Drug: Sterile buffered solution

Interventions

Sodium hyaluronate solution - 3.36% DRUG

Sodium hyaluronate solution, 3.36%, for intra-articular injection.

High and Low Molecular Weight Sodium Hyaluronate (HL-01)

Sterile buffered solution DRUG

Sodium chloride, for intra-articular injection.

Sterile buffered solution

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marta Bignamini

CONTACT

+4 158 360 1666; marta.bignamini@ibsa.ch

Study Design

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

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share