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Not yet recruitingNCT07819461Updated Oct 7, 2026

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 interventional study of Sodium hyaluronate solution - 3.36% and Sterile buffered solution in Osteo Arthritis of the Knee, sponsored by IBSA Institut Biochimique SA. Not yet recruiting. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by IBSA Institut Biochimique SA · Phase 3, Interventional, and Treatment

Updated Oct 7, 2026Title changedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
704
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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
02

Conditions studied

  • Osteo Arthritis of the Knee

Keywords

  • Osteoarthritis of the knee
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.

This study's planned enrollment of 704 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

IBSA Institut Biochimique SA is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Browse IBSA Institut Biochimique SA studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • (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 method if sexually active

Exclusion criteria

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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
704 participants (estimated)

Study arms

  • 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%

  • 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

Interventions

  • DrugSodium hyaluronate solution - 3.36%

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

  • DrugSterile buffered solution

    Sodium chloride, for intra-articular injection.

06

What researchers measure

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.

    Time frame: 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.

    Time frame: Baseline to Week 12.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.

Of 65 industry-sponsored phase 3 interventional studies under Osteoarthritis, Knee, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 27. This study's planned 9 months is below that.

Counting every sponsor, half of 100 studies reached it within 21 months; a quarter within 15 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2026
First posted
Sep 15, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): how it is measured was reworded
Oct 7, 2026
Title
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
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): how it is measured was reworded
    Title 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
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07819461
Lead sponsor
IBSA Institut Biochimique SA
Responsible party
Sponsor
First posted
Sep 15, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Marta Bignamini
Contact
marta.bignamini@ibsa.ch
+4 158 360 1666

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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