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
9 september 2026 bijgewerkt door: IBSA Institut Biochimique SA
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
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
704
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Marta Bignamini
- Telefoonnummer: +4 158 360 1666
- E-mail: marta.bignamini@ibsa.ch
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: High and Low Molecular Weight Sodium Hyaluronate (HL-01)
Patients will receive single intra-articular knee injection of 3.36% HL-01.
|
Sodium hyaluronate solution, 3.36%, for intra-articular injection.
|
|
Placebo-vergelijker: Sterile buffered solution
Patients randomized to placebo will receive single intra-articular knee injection of 3.36% sterile buffered solution (sodium chloride).
|
Sodium chloride, for intra-articular injection.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline of the average daily pain intensity score.
Tijdsspanne: 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.
|
From Baseline to Week 12
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Tijdsspanne: Baseline to Week 12.
|
Change in WOMAC function subscale from Baseline to Week 12.
|
Baseline to Week 12.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 september 2026
Primaire voltooiing (Geschat)
30 juni 2027
Studie voltooiing (Geschat)
30 juni 2027
Studieregistratiedata
Eerst ingediend
9 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 september 2026
Eerst geplaatst (Werkelijk)
15 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 september 2026
Laatste update ingediend die voldeed aan QC-criteria
9 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 24US-Hai08
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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