Osteo Arthritis of the KneePhase 3NCT07819461
A 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 study testing Sodium hyaluronate solution - 3.36% and Sterile buffered solution in people with Osteo Arthritis of the Knee, run by IBSA Institut Biochimique SA.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- Sodium hyaluronate solution - 3.36% and Sterile buffered solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 704 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
Read more
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
- Being tested
- Sodium hyaluronate solution - 3.36%, Sterile buffered solution
- Keywords
- Osteoarthritis of the knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate solution - 3.36%Drug
Sodium hyaluronate solution, 3.36%, for intra-articular injection.
Sterile buffered solutionDrug
Sodium chloride, for intra-articular injection.
| Study group | Role | What they receive |
|---|---|---|
| High and Low Molecular Weight Sodium Hyaluronate (HL-01) | Experimental | Patients will receive single intra-articular knee injection of 3.36% HL-01. Receives: 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). Receives: Drug: Sterile buffered solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Week 12
Secondary outcomes (1)
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Change in WOMAC function subscale from Baseline to Week 12. The test questions are scored on a 0 to 10 point NRS, with 0 meaning no symptom/difficulty and 10 meaning extreme symptom/difficulty. Each subscale score and the total score will be averaged to provide subscale and total scores between 0 and 10.
Measured: Baseline to Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 704 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819461
- Sponsor's protocol ID
- 24US-Hai08
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07819461
- Acronym / sponsor ID
- 24US-Hai08
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- Osteoarthritis of the knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 704 participants (estimated)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High and Low Molecular Weight Sodium Hyaluronate (HL-01) | Experimental | Drug: Sodium hyaluronate solution - 3.36%Patients will receive single intra-articular knee injection of 3.36% HL-01. |
| Sterile buffered solution | Placebo comparator | Drug: Sterile buffered solutionPatients randomized to placebo will receive single intra-articular knee injection of 3.36% sterile buffered solution (sodium chloride). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium hyaluronate solution - 3.36%Sodium hyaluronate solution, 3.36%, for intra-articular injection. | Drug | High and Low Molecular Weight Sodium Hyaluronate (HL-01) |
| Sterile buffered solutionSodium chloride, for intra-articular injection. | Drug | Sterile buffered solution |
Primary outcome
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.
1 secondary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline to Week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium hyaluronate solution - 3.36% and Sterile buffered solution in people with Osteo Arthritis of the Knee, run by IBSA Institut Biochimique SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Bignamini (+4 158 360 1666, marta.bignamini@ibsa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of the average daily pain intensity score. (time frame: From Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.