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Tests treatment safety and results for Osteoarthritis of the Knee
Official title Study to Assess the Safety and Pharmacokinetics of AVD275 Injection in Patients With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT07338266
What this study is testing
What is AVD275 Intra-articular Injection?
AVD275 Intra-articular Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for osteoarthritis of the knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to understand the safety, drug concentration and distribution of an intra-articular injectable formulation of celecoxib, AVD275, in patients with knee osteoarthritis. One single injection at three different doses of the drug will be studied in a sequential order, and each participant will be monitored for 24 weeks over ten clinical visits.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75
You may be able to join if
- Written consent to participate in the study; Willingness and ability to comply with the study procedures, visit schedules and follow verbal and...
- Male or female: 20 years to 75 years of age
- Symptoms associated with OA of the knee for ≥6 months prior to screening (patient reported is acceptable); Knee OA may be unilateral or bilateral
- Currently meets ACR Criteria (clinical and radiological) for OA as follows:
- Knee pain
You likely can't join if
- Any condition that could confound the patient's assessment of index knee pain in judgement of the investigator (for example, peri-articular pain of...
- Malalignment of greater than 10 degrees in the femorotibial axis of the index knee on standing; Unstable joint (such as tornanterior cruciate...
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis, arthritis associated with...
- Effusion at screening that likely requires joint aspiration for symptom relief from day 2 to day 83 during the study, as indicated by at least four...
- Intra-articular corticosteroids or intra-articular nonsteroidal antiinflammatory drugs (NSAIDs) (investigational or marketed) in the index knee...
- Intramuscular or oral corticosteroids within 1 month of screening
See the full eligibility criteria
Who can join
- Written consent to participate in the study; Willingness and ability to comply with the study procedures, visit schedules and follow verbal and written instructions
- Male or female: 20 years to 75 years of age
- Symptoms associated with OA of the knee for ≥6 months prior to screening (patient reported is acceptable); Knee OA may be unilateral or bilateral
- Currently meets ACR Criteria (clinical and radiological) for OA as follows:
- Knee pain
- At least one of the following:
- Age \> 50 years
- Stiffness \< 30 minutes
- Crepitus
- Osteophytes
- Kellgren-Lawrence (K-L) Grade 1-4 in the index knee based on X-ray performed during screening (locally read) within 6 months from screening
- Body mass index (BMI) ≤ 40 kg/m2
- Ambulatory and in good general health
What rules you out
- Any condition that could confound the patient's assessment of index knee pain in judgement of the investigator (for example, peri-articular pain of any cause or secondary arthritis that involves the index knee, joint...
- Malalignment of greater than 10 degrees in the femorotibial axis of the index knee on standing; Unstable joint (such as tornanterior cruciate ligament) or traumatic knee injury to the index knee (such as meniscal root...
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis, arthritis associated with inflammatory bowel disease, crystal disease of the index knee (e.g. gout...
- Effusion at screening that likely requires joint aspiration for symptom relief from day 2 to day 83 during the study, as indicated by at least four joint drainages in the past year
- Intra-articular corticosteroids or intra-articular nonsteroidal antiinflammatory drugs (NSAIDs) (investigational or marketed) in the index knee within 2 months of screening; Intra-articular hyaluronic acid...
- Intramuscular or oral corticosteroids within 1 month of screening
- Patients who received opioids (excluding tramadol and tapentadol) within 2 weeks of screening
- Any other investigational drug/biologic use within 3 months of screening
- Prior diagnostic arthroscopy to the index knee within 3 months of screening; Prior arthroscopic or open surgery of the index knee (including microfracture and meniscectomy) within 6 months of screening；Prior...
- Planned/anticipated surgery of the index knee, any other surgery, or hospitalization during the study period
- Known hypersensitivity to any form of NSAIDs (including celecoxib), sulfonamide-containing drugs, carboxymethyl cellulose, polysorbate 80 or lidocaine; History of severe allergic reactions
- Active or history of malignancy within the past 3 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the knee, or effectively managed cervical carcinoma
- Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral or parasitic infections (including HIV, hepatitis B or C viruses), or ocular herpes simplex; Any infection requiring intravenous...
- Any clinically significant laboratory parameters or ECG abnormality as judged by the investigator
- Uncontrolled diabetes as indicated by a hemoglobin A1c of \>7.5% at screening
- History of atherosclerotic cardiovascular disease (ASCVD) defined as prior myocardial infarction, stroke (ischaemic or haemorrhagic), transient ischemic attack, coronary revascularization (e.g., PCI, CABG), peripheral...
- OR a calculated 10-year ASCVD risk ≥10% based on age, sex, race, total/HDL cholesterol, systolic blood pressure, diabetes, smoking status;
- OR current use of dual antiplatelet therapy, chronic anticoagulation (e.g., warfarin, direct oral anticoagulants), or high-dose aspirin (\>300 mg/day)
- Abnormal liver function with AST or ALT \> 2 upper limit of normal (ULN) at screening
- Abnormal kidney function with eGFR \< 45 mL/min/1.73m2 at screening
- Platelet count outside normal range at screening
- WBC count \ 20000 cells/mm3 at screening
- Active uncontrolled psychiatric disorder including psychosis (e.g. schizophrenia), bipolar disorder, uncontrolled anxiety disorder and major depressive disorder
- Positive drug screen (opiates, amphetamines, cocaine metabolites, benzodiazepines, cannabinoids); Active substance abuse (drugs or alcohol), history of chronic substance abuse within the past year, or prior chronic...
- Skin breakdown at the knee where the injection would take place; Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site
- Women who are pregnant or nursing; Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using a highly effective method of contraception...
- Any other clinically significant acute or chronic medical conditions (e.g. bleeding disorder) that, in the judgement of the investigator, would preclude the use of an intra-articular NSAID or that could compromise...
The study team makes the final eligibility decision.
Where it's taking place
- Wahroonga, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wahroonga, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.