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
2026年9月9日 更新者：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
調査の概要
研究の種類
介入
入学 (推定)
704
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Marta Bignamini
- 電話番号：+4 158 360 1666
- メール：marta.bignamini@ibsa.ch
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline of the average daily pain intensity score.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
時間枠：Baseline to Week 12.
|
Change in WOMAC function subscale from Baseline to Week 12.
|
Baseline to Week 12.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月30日
一次修了 (推定)
2027年6月30日
研究の完了 (推定)
2027年6月30日
試験登録日
最初に提出
2026年9月9日
QC基準を満たした最初の提出物
2026年9月9日
最初の投稿 (実際)
2026年9月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月9日
最終確認日
2026年9月1日
詳しくは
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