Not yet recruiting

NCT Number: NCT07819461

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

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Osteo Arthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium hyaluronate solution - 3.36%

Drug

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

Sterile buffered solution

Drug

Sodium chloride, for intra-articular injection.

Primary outcomes

Change from Baseline of the average daily pain intensity score.

Time frame: From Baseline to Week 12

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.

Secondary outcomes

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

Time frame: Baseline to Week 12.

Change in WOMAC function subscale from Baseline to Week 12.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Bignamini

CONTACT

[email protected]

+4 158 360 1666

Sponsors and collaborators

Lead sponsor

IBSA Institut Biochimique SA

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 15, 2026
Registry last updated: Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting